Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Attain Performa(TM) Quadripolar Lead Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01751022
Recruitment Status : Completed
First Posted : December 17, 2012
Results First Posted : December 5, 2016
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Heart Failure
Intervention Device: Device: Attain Performa Pacing Lead (along with a standard CRT-D system)
Enrollment 1202
Recruitment Details  
Pre-assignment Details

Out of the 1202 Intial enrollments; 77 were excluded due to to the following pre-implant events:

  1. unsuccessful cannulation (25)
  2. death (3)
  3. Exit prior to implant attempt (43)
  4. Attain Performa Lead implant not attempted (6)

Resulting in 1125 subjects with Attain Performa Lead Implant Attempts

Arm/Group Title Model 4298 Model 4398 Model 4598
Hide Arm/Group Description Patients with an implant attempt for the Attain Performa Lead Model 4298 Patients with an implant attempt for the Attain Performa Lead Model 4398 Patients with an implant attempt for the Attain Performa Lead Model 4598
Period Title: Overall Study
Started 499 326 300
Completed 443 [1] 282 [1] 273 [1]
Not Completed 56 44 27
[1]
6 month visit
Arm/Group Title Attain Performa LV Lead Model 4298 Attain Performa LV Lead Model 4398 Attain Performa LV Lead Model 4598 Total
Hide Arm/Group Description Subjects with an attempted Attain Performa LV Lead Model 4298 implant Subjects with an attempted Attain Performa LV Lead Model 4398 implant Subjects with an attempted Attain Performa LV Lead Model 4598 implant Total of all reporting groups
Overall Number of Baseline Participants 499 326 300 1125
Hide Baseline Analysis Population Description
Subjects with an attempted Attain Performa LV Lead implant
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 499 participants 326 participants 300 participants 1125 participants
68  (11) 66  (11) 67  (11) 67  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 499 participants 326 participants 300 participants 1125 participants
Female
143
  28.7%
93
  28.5%
93
  31.0%
329
  29.2%
Male
356
  71.3%
233
  71.5%
207
  69.0%
796
  70.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 499 participants 326 participants 300 participants 1125 participants
Subject/physician chose not to provide information 14 9 5 28
Not reportable per local laws or regulations 30 21 48 99
American Indian or Alaska Native 4 0 5 9
Asian 7 8 17 32
Black or African American 38 21 17 76
Hispanic or Latino 18 11 11 40
Native Hawaiian or Pacific Islander 0 1 0 1
White or Caucasian 387 252 197 836
Two or more races 1 3 0 4
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 499 participants 326 participants 300 participants 1125 participants
United States 360 249 152 761
Malaysia 0 1 1 2
Greece 0 1 0 1
Saudi Arabia 9 6 2 17
Austria 8 0 2 10
Netherlands 13 1 9 23
Slovakia 4 2 7 13
Slovenia 0 5 3 8
Chile 12 0 0 12
France 0 2 8 10
Serbia 0 2 8 10
Romania 11 0 1 12
Hungary 0 3 4 7
United Kingdom 13 4 14 31
Switzerland 2 1 1 4
India 3 3 15 21
Spain 3 1 0 4
Canada 17 22 21 60
Belgium 3 1 5 9
Norway 5 0 0 5
Finland 0 3 1 4
Denmark 1 1 8 10
Italy 8 10 10 28
South Africa 3 2 2 7
Israel 0 2 2 4
Australia 17 1 5 23
Germany 7 3 19 29
New York Heart Association Classification (NYHA)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 499 participants 326 participants 300 participants 1125 participants
I 8 4 4 16
II 125 94 89 308
III 352 216 198 766
IV 14 12 9 35
[1]
Measure Description: NYHA Functional Classification is assessed as following. Class I: No limitation of physical activity. Class II:Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Unable to carry on any physical activity without discomfort. For more details see American Heart Association website http://www.heart.org/HEARTORG/Conditions/HeartFailure/AboutHeartFailure/Classes-of-Heart-Failure_UCM_306328_Article.jsp#.V_5rPPkrJD8
Left Ventricular Ejection Fraction (LVEF)  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 499 participants 326 participants 300 participants 1125 participants
25  (7) 26  (7) 27  (7) 26  (7)
QRS (Electrocardiogram Complex)  
Mean (Standard Deviation)
Unit of measure:  Ms
Number Analyzed 499 participants 326 participants 300 participants 1125 participants
155  (23) 156  (24) 156  (23) 156  (23)
1.Primary Outcome
Title Lead Complication-free Rate at 6 Months
Hide Description

The three Attain Performa LV leads models are evaluated separately. The primary safety objective is listed as following:

- Model 4298/4398: The Attain Performa Model 4298/4398 lead will be considered safe if the probability of subjects freed of Attain Performa lead-related complications at 6 months post-implant is greater than 87% (i.e., the one-sided 97.5% lower confidence bound must be greater than 87%).

- Model 4598: The safety performance of the Attain Performa Model 4598 lead will be characterized by summarizing the probability of subjects who are free from Attain Performa LV lead related complications at 6 months.

The lower boundaries of the 97.5% confidence intervals for the all lead models are greater than the pacing threshold of 87%, thus concluding that the crtiera was met for all lead models.

Time Frame Implant to 6 months post-implant
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with an attempted Attain Performa LV Lead Model. Results for lead model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; results for lead model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; results for lead model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.
Arm/Group Title Attain Performa LV Lead Model 4298 Attain Performa LV Lead Model 4398 Attain Performa LV Lead Model 4598
Hide Arm/Group Description:
Subjects with an attempted Attain Performa LV Lead Model 4298 implant.
Subjects with an attempted Attain Performa LV Lead Model 4398 implant.
Subjects with an attempted Attain Performa LV Lead Model 4598 implant.
Overall Number of Participants Analyzed 499 326 300
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: Survival Probability (%)
96.04
(94.30 to 100)
98.75
(97.55 to 100)
96.21
(94.04 to 100)
2.Primary Outcome
Title LV Pacing Capture Thresholds Per Attain Performa Lead Model
Hide Description [Not Specified]
Time Frame 6 months post-implant
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with Attain Performa LV Lead Model implanted and valid pacing thresholds measured at the 6 month follow-up visit. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report V. 1, 29AUG2014.
Arm/Group Title Attain Performa LV Lead Model 4298 Attain Performa LV Lead Model 4398 Attain Performa LV Lead Model 4598
Hide Arm/Group Description:
Subjects with Attain Performa LV Lead Model 4298 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
Subjects with Attain Performa LV Lead Model 4398 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
Subjects with Attain Performa LV Lead Model 4598 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
Overall Number of Participants Analyzed 395 266 266
Mean (97.5% Confidence Interval)
Unit of Measure: percentage of participants
93.92
(91.09 to 100)
96.24
(93.20 to 100)
95.86
(92.72 to 100)
3.Secondary Outcome
Title Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities
Hide Description Percentage of patients with presence of PNS in all LV lead pacing polarities at 8.0 V at 0.5ms performed at 6-month visit.
Time Frame 6 months post-implant
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with Attain Performa LV Lead implanted and at least 1 valid pacing threshold at any LV lead pacing polarity measured at the 6 month visit. Results for model 4298 comes from its PMA-S Clinical Report V1, 27MAR14; for model 4398 comes from its PMA-S Clinical Report V3, 03SEP14; for model 4598 comes from its PMA-S Clinical Report V1, 29AUG14.
Arm/Group Title Attain Performa LV Lead Model 4298 Attain Performa LV Lead Model 4398 Attain Performa LV Lead Model 4598
Hide Arm/Group Description:
Subjects with Attain Performa LV Lead Model 4298 implanted and at least one valid pacing threshold at any LV lead pacing polarity measured at the 6 month follow-up visit.
Subjects with Attain Performa LV Lead Model 4398 implanted and at least one valid pacing threshold at any LV lead pacing polarity measured at the 6 month follow-up visit.
Subjects with Attain Performa LV Lead Model 4598 implanted and at least one valid pacing threshold at any LV lead pacing polarity measured at the 6 month.
Overall Number of Participants Analyzed 395 267 267
Measure Type: Number
Unit of Measure: percentage of participants
LV1-RV COIL 42.03 44.19 44.57
LV1-LV2 38.48 40.45 35.58
LV1-LV3 38.99 40.45 35.58
LV1-LV4 34.18 34.83 37.83
LV2-RV COIL 33.92 33.71 27.72
LV2 -LV1 34.94 32.21 27.34
LV2-LV3 12.66 18.35 10.86
LV2-LV4 27.85 25.47 22.47
LV3-RV COIL 31.39 31.84 24.72
LV3-LV1 33.42 31.46 31.84
LV3-LV2 12.91 15.36 8.61
LV3-LV4 26.58 23.60 18.73
LV4-RV COIL 21.52 17.98 19.10
LV4-LV1 26.58 24.34 24.72
LV4-LV2 21.27 20.22 17.60
LV4-LV3 20.76 19.10 16.10
4.Secondary Outcome
Title Percentage of Subjects With Successful Implant Per Attain Performa Lead Model
Hide Description [Not Specified]
Time Frame Implant up to 1-month post implant
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with an attempted Attain Performa LV Lead Model. Results for lead model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; results for lead model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; results for lead model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.
Arm/Group Title Model 4298 Model 4398 Model 4598
Hide Arm/Group Description:
Patients with an implant attempt for the Attain Performa Lead Model 4298
Patients with an implant attempt for the Attain Performa Lead Model 4398
Patients with an implant attempt for the Attain Performa Lead Model 4598
Overall Number of Participants Analyzed 499 326 300
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
97.60
(95.84 to 98.75)
97.55
(95.22 to 98.93)
98.00
(95.70 to 99.26)
5.Secondary Outcome
Title Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model
Hide Description [Not Specified]
Time Frame Implant up to 1-month post implant
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with an attempted Attain Performa LV Lead Model. Results for lead model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; results for lead model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; results for lead model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.
Arm/Group Title Attain Performa LV Lead Model 4298 Attain Performa LV Lead Model 4398 Attain Performa LV Lead Model 4598
Hide Arm/Group Description:
Subjects with an attempted Attain Performa LV Lead Model 4298 implant
Subjects with an attempted Attain Performa LV Lead Model 4398 implant
Subjects with an attempted Attain Performa LV Lead Model 4598 implant
Overall Number of Participants Analyzed 499 326 300
Measure Type: Number
Unit of Measure: percentage of participants
Acceptable 98.00 98.47 98.67
Unacceptable 0.20 0.31 0.33
No Response 1.80 1.23 1.00
6.Secondary Outcome
Title Pacing Capture Thresholds at the Final Programmed Pacing Polarity
Hide Description [Not Specified]
Time Frame 6 months post-implant
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with Attain Performa LV Lead Model implanted and valid pacing thresholds measured at the 6 month follow-up visit. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report V. 1, 29AUG2014.
Arm/Group Title Attain Performa LV Lead Model 4298 Attain Performa LV Lead Model 4398 Attain Performa LV Lead Model 4598
Hide Arm/Group Description:
Subjects with Attain Performa LV Lead Model 4298 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
Subjects with Attain Performa LV Lead Model 4398 implanted and valid pacing thresholds measured at the 6 month follow-up.
Subjects with Attain Performa LV Lead Model 4598 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
Overall Number of Participants Analyzed 395 266 266
Mean (Standard Deviation)
Unit of Measure: Volts
1.06  (0.74) 1.15  (0.76) 1.10  (0.79)
7.Secondary Outcome
Title Implant Related Times Per Attain Performa Lead Model
Hide Description [Not Specified]
Time Frame Implant up to 1-month post implant
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with Attain Performa LV Lead Model successfully implanted. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.
Arm/Group Title Attain Performa LV Lead Model 4298 Attain Performa LV Lead Model 4398 Attain Performa LV Lead Model 4598
Hide Arm/Group Description:
Subjects with Attain Performa LV Lead Model 4298 implanted successfully.
Subjects with Attain Performa LV Lead Model 4398 implanted successfully.
Subjects with Attain Performa LV Lead Model 4598 implanted successfully.
Overall Number of Participants Analyzed 487 318 294
Mean (Standard Deviation)
Unit of Measure: minutes
Cannulation 6.3  (9.5) 8.45  (14.47) 6.87  (11.19)
Fluoroscopy 21.7  (15.4) 23.00  (17.29) 18.77  (12.66)
LV Lead Placement 13.0  (15.9) 17.26  (26.21) 11.82  (14.17)
Total Operation 109.6  (49.0) 107.96  (53.46) 95.09  (43.38)
8.Secondary Outcome
Title Pacing Impedance at the Final Programmed Pacing Polarity
Hide Description

Pacing impedance for each LV pacing polarity. Noticed that pacing impedance values are not recorded for reversed LV pacing polarities, since impedance from LV1 to LV2 is the same as from LV2 to LV1.

Impedance is a measurement of current/resistance between the pacing lead and the cardiac tissue (measured in Ohms).

Time Frame 6 month post-implant
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with Attain Performa LV lead implanted and complete Medtronic Quad CRT-D system and valid measures of lead impedance at 6-month visit. Results for model 4298 comes from its PMA-S Clinical Report V1, 27MAR14; for model 4398 comes from its PMA-S Clinical Report V3, 03SEP14; for model 4598 comes from its PMA-S Clinical Report V1, 29AUG14.
Arm/Group Title Attain Performa LV Lead Model 4298 Attain Performa LV Lead Model 4398 Attain Performa LV Lead Model 4598
Hide Arm/Group Description:
Subjects with Attain Performa LV Lead Model 4298 implanted and complete Medtronic Quad CRT-D system and valid measures of lead impedance at 6-month visit.
Subjects with Attain Performa LV Lead Model 4398 implanted and complete Medtronic Quad CRT-D system and valid measures of lead impedance at 6-month visit.
Subjects with Attain Performa LV Lead Model 4598 implanted and complete Medtronic Quad CRT-D system and valid measures of lead impedance at 6-month visit.
Overall Number of Participants Analyzed 395 266 267
Mean (Standard Deviation)
Unit of Measure: Ohms
LV1 to RV Coil 460.56  (124.26) 466.24  (123.63) 496.45  (133.92)
LV1 to LV2 780.49  (228.00) 802.52  (240.30) 826.69  (275.82)
LV1 to LV3 776.64  (192.41) 792.62  (195.78) 826.15  (278.05)
LV1 to LV4 750.14  (171.98) 761.79  (175.08) 799.70  (225.09)
LV2 to RV Coil 462.63  (168.82) 476.71  (193.46) 483.99  (247.31)
LV2 to LV3 562.40  (179.24) 568.36  (197.87) 580.02  (247.99)
LV2 to LV4 730.26  (196.11) 755.85  (214.04) 756.48  (257.78)
LV3 to RV Coil 450.29  (107.29) 458.86  (110.62) 468.90  (247.12)
LV3 to LV4 715.20  (159.58) 733.30  (164.21) 740.99  (254.57)
LV4 to RV Coil 406.24  (87.12) 407.17  (87.09) 421.69  (180.51)
9.Secondary Outcome
Title Complication Rate for Individual Attain Performa Lead Related Events
Hide Description [Not Specified]
Time Frame 6 month post-Implant
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with Attain Performa LV Lead Model successfully implanted. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.
Arm/Group Title Attain Performa LV Lead Model 4298 Attain Performa LV Lead Model 4398 Attain Performa LV Lead Model 4598
Hide Arm/Group Description:
Subjects with Attain Performa LV Lead Model 4298 implanted successfully.
Subjects with Attain Performa LV Lead Model 4398 implanted successfully.
Subjects with Attain Performa LV Lead Model 4598 implanted successfully.
Overall Number of Participants Analyzed 487 318 294
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3.70
(2.20 to 5.78)
1.58
(0.51 to 3.64)
3.74
(1.88 to 6.60)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Attain Performa LV Lead Model 4298 Attain Performa LV Lead Model 4398 Attain Performa LV Lead Model 4598
Hide Arm/Group Description Subjects with an attempted Attain Performa LV Lead Model 4298 implant. Results as showed in the Model 4298 PMA-S Clinical Report Version 1, 27MAR2014. Subjects with an attempted Attain Performa LV Lead Model 4398 implant. Results as showed in the Model 4398 PMA-S Clinical Report Version 3, 03SEP2014. Subjects with an attempted Attain Performa LV Lead Model 4598 implant. Results as showed in the Model 4598 PMA-S Clinical Report Version 1, 29AUG2014.
All-Cause Mortality
Attain Performa LV Lead Model 4298 Attain Performa LV Lead Model 4398 Attain Performa LV Lead Model 4598
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Attain Performa LV Lead Model 4298 Attain Performa LV Lead Model 4398 Attain Performa LV Lead Model 4598
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   218/499 (43.69%)      134/326 (41.10%)      117/300 (39.00%)    
Blood and lymphatic system disorders       
Anemia  1  5/499 (1.00%)  5 1/326 (0.31%)  1 2/300 (0.67%)  2
Cardiac disorders       
AFib  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Acute coronary syndrome  1  1/499 (0.20%)  1 2/326 (0.61%)  2 1/300 (0.33%)  1
Acute heart failure  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Alcoholic cardiomyopathy  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Angina pectoris  1  1/499 (0.20%)  1 2/326 (0.61%)  2 0/300 (0.00%)  0
Aortic regurgitation  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Aortic valve stenosis  1  2/499 (0.40%)  2 0/326 (0.00%)  0 0/300 (0.00%)  0
Arrhythmia supraventricular  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Arteriosclerosis coronary artery  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  2
Asystole  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Atrial arrhythmia  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Atrial fibrillation  1  16/499 (3.21%)  18 12/326 (3.68%)  16 3/300 (1.00%)  3
Atrial fibrillation paroxysmal  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Atrial fibrillation with rapid ventricular response  1  4/499 (0.80%)  4 1/326 (0.31%)  1 3/300 (1.00%)  3
Atrial flutter  1  4/499 (0.80%)  5 5/326 (1.53%)  7 2/300 (0.67%)  2
Atrial tachycardia  1  1/499 (0.20%)  1 0/326 (0.00%)  0 1/300 (0.33%)  1
Atypical angina  1  2/499 (0.40%)  2 2/326 (0.61%)  9 1/300 (0.33%)  1
Cardiac arrest  1  0/499 (0.00%)  0 4/326 (1.23%)  4 0/300 (0.00%)  0
Cardiac arrhythmia  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Cardiac perforation  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Cardiac tamponade  1  0/499 (0.00%)  0 1/326 (0.31%)  1 2/300 (0.67%)  2
Cardiogenic shock  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Cardiomyopathy  1  0/499 (0.00%)  0 2/326 (0.61%)  2 0/300 (0.00%)  0
Cardiopulmonary arrest  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Cardiorenal syndrome  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Cardiovascular disease, unspecified  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Chronic heart failure  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Congestive heart failure  1  1/499 (0.20%)  1 4/326 (1.23%)  4 2/300 (0.67%)  2
Coronary artery disease  1  2/499 (0.40%)  3 0/326 (0.00%)  0 1/300 (0.33%)  1
Decompensated heart failure  1  57/499 (11.42%)  84 30/326 (9.20%)  51 33/300 (11.00%)  46
Electromechanical dissociation  1  1/499 (0.20%)  1 0/326 (0.00%)  0 1/300 (0.33%)  1
Heart fluttering  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Intracardiac mass  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Left ventricular dysfunction  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Mitral valve disease  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Monomorphic ventricular tachycardia  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Myocardial infarction  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Non ST segment elevation myocardial infarction  1  1/499 (0.20%)  1 2/326 (0.61%)  3 3/300 (1.00%)  3
Non-ischemic cardiomyopathy  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Non-sustained ventricular tachycardia  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Paroxysmal atrial fibrillation  1  0/499 (0.00%)  0 2/326 (0.61%)  2 0/300 (0.00%)  0
Pericardial effusion  1  2/499 (0.40%)  2 3/326 (0.92%)  4 0/300 (0.00%)  0
Pericarditis  1  1/499 (0.20%)  1 1/326 (0.31%)  1 0/300 (0.00%)  0
Permanent atrial fibrillation  1  0/499 (0.00%)  0 0/326 (0.00%)  0 2/300 (0.67%)  2
Persistent atrial fibrillation  1  3/499 (0.60%)  3 2/326 (0.61%)  2 4/300 (1.33%)  4
Premature ventricular contractions  1  3/499 (0.60%)  3 0/326 (0.00%)  0 0/300 (0.00%)  0
Recurrent atrial fibrillation  1  0/499 (0.00%)  0 0/326 (0.00%)  0 2/300 (0.67%)  2
Supraventricular tachycardia  1  0/499 (0.00%)  0 2/326 (0.61%)  2 1/300 (0.33%)  1
Sustained ventricular tachycardia  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Systolic dysfunction  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Tachyarrhythmia  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Tachycardia  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Torsades de pointes  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Tricuspid valve disease  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Unstable angina  1  3/499 (0.60%)  3 0/326 (0.00%)  0 0/300 (0.00%)  0
Ventricular ectopic beats  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Ventricular fibrillation  1  3/499 (0.60%)  3 0/326 (0.00%)  0 3/300 (1.00%)  3
Ventricular flutter  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Ventricular tachyarrhythmia  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Ventricular tachycardia  1  4/499 (0.80%)  4 1/326 (0.31%)  1 7/300 (2.33%)  8
Congenital, familial and genetic disorders       
Patent ductus arteriosus  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Ear and labyrinth disorders       
Benign paroxysmal positional vertigo  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Vertigo positional  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Endocrine disorders       
Hyperthyroidism  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Eye disorders       
Right cataract  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Vitreous hemorrhage  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Gastrointestinal disorders       
Abdominal catastrophe  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Abdominal pain  1  2/499 (0.40%)  3 2/326 (0.61%)  2 1/300 (0.33%)  1
Acute duodenal ulcer  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Acute pancreatitis  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Antral ulcer  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Barrett s esophagus  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Diarrhea  1  1/499 (0.20%)  2 0/326 (0.00%)  0 1/300 (0.33%)  1
Diverticular perforation  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
GI bleed  1  7/499 (1.40%)  9 2/326 (0.61%)  2 2/300 (0.67%)  2
GI upset  1  1/499 (0.20%)  1 1/326 (0.31%)  1 0/300 (0.00%)  0
Gastro intestinal bleed  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Gastrocutaneous fistula  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Gastrointestinal bleed  1  1/499 (0.20%)  1 0/326 (0.00%)  0 1/300 (0.33%)  1
Hernia hiatal  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Inguinal hernia  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Intestinal mass  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Irritable bowel syndrome  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Nausea  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Oesophageal reflux  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Parotid cyst  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Ruptured diverticulum  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Small bowel obstruction  1  2/499 (0.40%)  2 0/326 (0.00%)  0 0/300 (0.00%)  0
Umbilical hernia  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Vomiting  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
General disorders       
Adverse drug reaction  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Chest Pain  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Chest discomfort  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Chest pain  1  10/499 (2.00%)  10 7/326 (2.15%)  24 3/300 (1.00%)  3
Chest tightness  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Chronic chest pain  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Coronary restenosis  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Device capturing issue  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Device connection issue  1  3/499 (0.60%)  3 2/326 (0.61%)  2 1/300 (0.33%)  1
Device malfunction  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Drug side effect  1  0/499 (0.00%)  0 3/326 (0.92%)  3 0/300 (0.00%)  0
Elevated pacing threshold  1  2/499 (0.40%)  2 0/326 (0.00%)  0 0/300 (0.00%)  0
Fever  1  1/499 (0.20%)  1 1/326 (0.31%)  1 0/300 (0.00%)  0
Hypothermia  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Implant site edema  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Implant site erythema  1  2/499 (0.40%)  2 0/326 (0.00%)  0 0/300 (0.00%)  0
Implant site hematoma  1  2/499 (0.40%)  2 2/326 (0.61%)  2 1/300 (0.33%)  1
Implant site pain  1  3/499 (0.60%)  3 1/326 (0.31%)  1 0/300 (0.00%)  0
Inappropriate phrenic nerve stimulation  1  1/499 (0.20%)  1 1/326 (0.31%)  2 0/300 (0.00%)  0
Inappropriate stimulation of diaphragm  1  1/499 (0.20%)  1 1/326 (0.31%)  1 0/300 (0.00%)  0
Injection site reaction  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Lead dislodgement  1  16/499 (3.21%)  17 3/326 (0.92%)  4 8/300 (2.67%)  8
Loss of capture  1  1/499 (0.20%)  1 1/326 (0.31%)  1 0/300 (0.00%)  0
Multi organ failure  1  2/499 (0.40%)  2 0/326 (0.00%)  0 1/300 (0.33%)  1
Non-cardiac chest pain  1  2/499 (0.40%)  2 2/326 (0.61%)  4 1/300 (0.33%)  1
Pain  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Phantom shocks  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Premature battery depletion  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Substernal chest pain  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Sudden death  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Undersensing  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Unknown cause of death  1  4/499 (0.80%)  4 1/326 (0.31%)  1 4/300 (1.33%)  4
Weakness  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Hepatobiliary disorders       
Acute cholecystitis  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Cholecystitis  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Cholelithiasis  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Chronic cholecystitis  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Hepatitis  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Infections and infestations       
Abdominal sepsis  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Abscess jaw  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Acute bronchitis  1  1/499 (0.20%)  1 1/326 (0.31%)  1 1/300 (0.33%)  1
Acute gastroenteritis  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Acute tracheobronchitis  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Appendicitis  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Bacteremia  1  3/499 (0.60%)  4 1/326 (0.31%)  1 0/300 (0.00%)  0
Bronchitis  1  1/499 (0.20%)  1 1/326 (0.31%)  1 0/300 (0.00%)  0
Bronchitis acute  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Bronchitis viral  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Bronchopneumonia  1  1/499 (0.20%)  1 1/326 (0.31%)  1 0/300 (0.00%)  0
C.difficile colitis  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Cellulitis  1  1/499 (0.20%)  1 1/326 (0.31%)  1 0/300 (0.00%)  0
Cellulitis of leg  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Cellulitis of toe  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Diverticulitis  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Endocarditis  1  1/499 (0.20%)  1 1/326 (0.31%)  1 0/300 (0.00%)  0
Gastroenteritis  1  0/499 (0.00%)  0 1/326 (0.31%)  1 1/300 (0.33%)  1
Implant site infection  1  5/499 (1.00%)  5 2/326 (0.61%)  2 2/300 (0.67%)  2
Infection of amputation stump  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Neutropenic sepsis  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Osteomyelitis  1  0/499 (0.00%)  0 0/326 (0.00%)  0 2/300 (0.67%)  2
Peritonitis  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Pneumonia  1  7/499 (1.40%)  8 8/326 (2.45%)  9 9/300 (3.00%)  12
Prosthesis related infection  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Pulmonary sepsis  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Renal abscess  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Sepsis  1  5/499 (1.00%)  5 2/326 (0.61%)  3 1/300 (0.33%)  1
Sepsis MRSA  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Sepsis syndrome  1  0/499 (0.00%)  0 0/326 (0.00%)  0 2/300 (0.67%)  3
Septic joint  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Septic shock  1  2/499 (0.40%)  2 0/326 (0.00%)  0 1/300 (0.33%)  1
Sigmoid diverticulitis  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Staphylococcal infection  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Staphylococcus aureus septicemia  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Streptococcus viridans group infection  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Urinary tract infection  1  5/499 (1.00%)  6 0/326 (0.00%)  0 2/300 (0.67%)  2
Injury, poisoning and procedural complications       
Compression fracture  1  2/499 (0.40%)  2 1/326 (0.31%)  1 0/300 (0.00%)  0
Contusion of hip  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Digoxin toxicity  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
False aneurysm  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Femur fracture  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Foreign body in esophagus  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Fracture  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Fractured cervical spine  1  1/499 (0.20%)  1 1/326 (0.31%)  1 0/300 (0.00%)  0
Hip fracture  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Humerus fracture  1  2/499 (0.40%)  2 0/326 (0.00%)  0 1/300 (0.33%)  1
Intraoperative bleeding  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Medication error  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Motor vehicle accident  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Patella fracture  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Postoperative bleeding  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Seroma  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Spurious aneurysm  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Stab wound  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Subdural hematoma  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Subdural hemorrhage  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Therapeutic procedural complication  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Trochanteric femoral fracture  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Twiddler s syndrome  1  1/499 (0.20%)  1 0/326 (0.00%)  0 2/300 (0.67%)  2
Vascular pseudoaneurysm  1  1/499 (0.20%)  2 1/326 (0.31%)  1 0/300 (0.00%)  0
Investigations       
Abnormal coagulation profile  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Elevated liver enzymes  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Subtherapeutic INR  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration  1  2/499 (0.40%)  2 0/326 (0.00%)  0 1/300 (0.33%)  1
Diabetes mellitus  1  1/499 (0.20%)  1 0/326 (0.00%)  0 1/300 (0.33%)  1
Failure to thrive  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Gout  1  2/499 (0.40%)  2 0/326 (0.00%)  0 0/300 (0.00%)  0
Hyperkalemia  1  2/499 (0.40%)  2 0/326 (0.00%)  0 1/300 (0.33%)  1
Hypoglycemia  1  1/499 (0.20%)  1 1/326 (0.31%)  1 0/300 (0.00%)  0
Hypokalemia  1  3/499 (0.60%)  4 0/326 (0.00%)  0 0/300 (0.00%)  0
Hyponatremia  1  5/499 (1.00%)  5 1/326 (0.31%)  1 0/300 (0.00%)  0
Hypovolemia  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Volume depletion  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Volume overload  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Musculoskeletal and connective tissue disorders       
Arthritis  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Arthrosis  1  0/499 (0.00%)  0 1/326 (0.31%)  1 1/300 (0.33%)  1
Back pain  1  0/499 (0.00%)  0 1/326 (0.31%)  1 1/300 (0.33%)  1
Cervical disc herniation  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Degenerative joint disease  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Muscle weakness  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Osteoarthritis  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Osteoarthritis knee  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Pain in hip  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Rhabdomyolysis  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Rheumatoid arthritis  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Tendonitis  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Adenocarcinoma  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Adenocarcinoma lung  1  2/499 (0.40%)  2 0/326 (0.00%)  0 0/300 (0.00%)  0
Bladder cancer  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Bowel cancer  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Breast cancer  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Colon cancer  1  1/499 (0.20%)  1 0/326 (0.00%)  0 1/300 (0.33%)  1
Lung adenocarcinoma  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Lung cancer  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Multiple myeloma  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Multiple myeloma progression  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Pancreatic adenocarcinoma  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Pancreatic cancer  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Pituitary tumour  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Prostate adenoma  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Prostate cancer  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Renal cell carcinoma  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Squamous cell carcinoma of lung  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Nervous system disorders       
Ataxia  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
CVA  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Carotid artery stenosis  1  1/499 (0.20%)  1 1/326 (0.31%)  1 1/300 (0.33%)  1
Cerebral infarct  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Cerebrovascular accident  1  1/499 (0.20%)  1 1/326 (0.31%)  1 0/300 (0.00%)  0
Convulsive seizure  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Dizziness  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Dysarthria  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Encephalopathy  1  1/499 (0.20%)  1 0/326 (0.00%)  0 1/300 (0.33%)  1
Headache  1  2/499 (0.40%)  2 0/326 (0.00%)  0 0/300 (0.00%)  0
Hemorrhagic stroke  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Hepatic encephalopathy  1  1/499 (0.20%)  2 0/326 (0.00%)  0 0/300 (0.00%)  0
Hydrocephalus  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Intracerebral hemorrhage  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Intracranial hemorrhage  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Ischemic stroke  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Lethargy  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Lightheadedness  1  2/499 (0.40%)  2 0/326 (0.00%)  0 0/300 (0.00%)  0
Metabolic encephalopathy  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Myasthenia gravis  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Myasthenia gravis crisis  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Myelitis transverse  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Stroke  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Syncope  1  6/499 (1.20%)  6 2/326 (0.61%)  2 3/300 (1.00%)  3
Transient ischemic attacks  1  1/499 (0.20%)  1 0/326 (0.00%)  0 2/300 (0.67%)  2
Psychiatric disorders       
Acute delirium  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Delirium  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Hallucinations  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Mental status changes  1  2/499 (0.40%)  2 0/326 (0.00%)  0 1/300 (0.33%)  1
Renal and urinary disorders       
Acute kidney injury  1  1/499 (0.20%)  1 1/326 (0.31%)  3 1/300 (0.33%)  1
Acute on chronic renal failure  1  1/499 (0.20%)  1 0/326 (0.00%)  0 1/300 (0.33%)  1
Acute renal failure  1  5/499 (1.00%)  6 2/326 (0.61%)  2 3/300 (1.00%)  6
Acute renal insufficiency  1  0/499 (0.00%)  0 1/326 (0.31%)  1 2/300 (0.67%)  2
Chronic kidney disease  1  2/499 (0.40%)  2 2/326 (0.61%)  3 0/300 (0.00%)  0
Chronic renal insufficiency  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Dysuria  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Hematuria  1  1/499 (0.20%)  1 2/326 (0.61%)  2 0/300 (0.00%)  0
Injury to kidney  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Kidney failure  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Kidney stone  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Renal failure  1  5/499 (1.00%)  5 1/326 (0.31%)  1 2/300 (0.67%)  2
Renal insufficiency  1  1/499 (0.20%)  1 1/326 (0.31%)  1 2/300 (0.67%)  2
Renal mass  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Retention urinary  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Urinary incontinence  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Urinary retention  1  0/499 (0.00%)  0 1/326 (0.31%)  1 1/300 (0.33%)  1
Reproductive system and breast disorders       
Ovarian mass  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Respiratory, thoracic and mediastinal disorders       
Acute on chronic respiratory failure  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Acute pulmonary edema  1  2/499 (0.40%)  2 0/326 (0.00%)  0 1/300 (0.33%)  1
Acute respiratory distress syndrome  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Acute respiratory failure  1  3/499 (0.60%)  3 2/326 (0.61%)  2 0/300 (0.00%)  0
Aspiration pneumonia  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
COPD  1  0/499 (0.00%)  0 2/326 (0.61%)  2 1/300 (0.33%)  1
COPD exacerbation  1  1/499 (0.20%)  5 0/326 (0.00%)  0 1/300 (0.33%)  1
Chronic obstructive pulmonary disease  1  1/499 (0.20%)  1 1/326 (0.31%)  1 1/300 (0.33%)  1
Dyspnea  1  0/499 (0.00%)  0 2/326 (0.61%)  2 1/300 (0.33%)  1
Flash pulmonary edema  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Hemothorax  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Hypercapnic respiratory failure  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Interstitial pulmonary fibrosis  1  1/499 (0.20%)  1 0/326 (0.00%)  0 1/300 (0.33%)  1
Lung nodule  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Pleural effusion  1  3/499 (0.60%)  4 0/326 (0.00%)  0 1/300 (0.33%)  1
Pleuritic pain  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Pneumothorax  1  5/499 (1.00%)  6 3/326 (0.92%)  3 4/300 (1.33%)  4
Pulmonary embolism  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Pulmonary hypertension  1  1/499 (0.20%)  1 0/326 (0.00%)  0 1/300 (0.33%)  1
Pulmonary toxicity  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Respiratory failure  1  4/499 (0.80%)  4 2/326 (0.61%)  2 0/300 (0.00%)  0
Respiratory insufficiency  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Shortness of breath  1  0/499 (0.00%)  0 1/326 (0.31%)  1 1/300 (0.33%)  1
Sleep apnea  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Skin and subcutaneous tissue disorders       
Angioedema  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Diabetic foot ulcer  1  1/499 (0.20%)  1 0/326 (0.00%)  0 1/300 (0.33%)  1
Dry gangrene  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Foot ulcer  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Surgical and medical procedures       
AV fistula excision  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Enterostomy closure  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Inguinal hernia repair  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Vascular disorders       
Aneurysm  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Aortic aneurysm rupture  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Aortic stenosis  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Arterial bleeding  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Bleeding varicose vein  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Claudication  1  0/499 (0.00%)  0 1/326 (0.31%)  1 1/300 (0.33%)  3
DVT  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Deep vein thrombosis  1  2/499 (0.40%)  2 3/326 (0.92%)  3 1/300 (0.33%)  1
Hemorrhage  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Hypertension  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Hypertension worsened  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Hypertensive episode  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Hypotension  1  4/499 (0.80%)  6 2/326 (0.61%)  2 5/300 (1.67%)  5
Ischemia  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Leg ischemia  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Obstructive arteriosclerosis of lower extremities  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Orthostatic hypotension  1  0/499 (0.00%)  0 1/326 (0.31%)  1 2/300 (0.67%)  2
Peripheral arterial disease  1  1/499 (0.20%)  1 0/326 (0.00%)  0 1/300 (0.33%)  1
Peripheral arterial occlusive disease  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Peripheral vascular disease  1  0/499 (0.00%)  0 2/326 (0.61%)  2 1/300 (0.33%)  1
Subclavian vein thrombosis  1  0/499 (0.00%)  0 0/326 (0.00%)  0 2/300 (0.67%)  2
Uncontrolled hypertension  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Attain Performa LV Lead Model 4298 Attain Performa LV Lead Model 4398 Attain Performa LV Lead Model 4598
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   155/499 (31.06%)      84/326 (25.77%)      84/300 (28.00%)    
Blood and lymphatic system disorders       
Leukocytosis  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Cardiac disorders       
AFib  1  1/499 (0.20%)  1 0/326 (0.00%)  0 1/300 (0.33%)  1
Acute coronary syndrome  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Angina pectoris  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Atrial fibrillation  1  12/499 (2.40%)  13 3/326 (0.92%)  3 12/300 (4.00%)  13
Atrial fibrillation with rapid ventricular response  1  1/499 (0.20%)  1 1/326 (0.31%)  1 0/300 (0.00%)  0
Atrial flutter  1  2/499 (0.40%)  3 2/326 (0.61%)  2 0/300 (0.00%)  0
Atrial tachycardia  1  3/499 (0.60%)  3 2/326 (0.61%)  2 1/300 (0.33%)  1
Atypical angina  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Bradycardia  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Cardiac sarcoidosis  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Congestive heart failure  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Coronary artery disease  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Decompensated heart failure  1  31/499 (6.21%)  35 18/326 (5.52%)  18 14/300 (4.67%)  17
Junctional rhythm  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
LV dyssynchrony  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Monomorphic ventricular tachycardia  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Non-sustained ventricular tachycardia  1  4/499 (0.80%)  4 2/326 (0.61%)  2 1/300 (0.33%)  2
Palpitations  1  2/499 (0.40%)  2 0/326 (0.00%)  0 3/300 (1.00%)  3
Paroxysmal atrial fibrillation  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Paroxysmal atrial tachycardia  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Paroxysmal ventricular tachycardia  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Pericardial effusion  1  1/499 (0.20%)  1 0/326 (0.00%)  0 1/300 (0.33%)  1
Persistent atrial fibrillation  1  2/499 (0.40%)  2 0/326 (0.00%)  0 0/300 (0.00%)  0
Premature beat atrial  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Premature ventricular contractions  1  1/499 (0.20%)  1 2/326 (0.61%)  2 0/300 (0.00%)  0
Recurrent ventricular tachycardia  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Sinus tachycardia  1  1/499 (0.20%)  1 2/326 (0.61%)  2 0/300 (0.00%)  0
Supraventricular tachycardia  1  4/499 (0.80%)  4 0/326 (0.00%)  0 1/300 (0.33%)  1
Sustained ventricular tachycardia  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  2
Tachycardia  1  0/499 (0.00%)  0 1/326 (0.31%)  1 1/300 (0.33%)  1
Ventricular fibrillation  1  2/499 (0.40%)  4 1/326 (0.31%)  1 1/300 (0.33%)  1
Ventricular tachycardia  1  8/499 (1.60%)  9 2/326 (0.61%)  2 3/300 (1.00%)  3
Gastrointestinal disorders       
Vomiting  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
General disorders       
Adverse drug reaction  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Chest pain  1  8/499 (1.60%)  11 3/326 (0.92%)  3 4/300 (1.33%)  4
Chest pressure  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Device alarm issue  1  2/499 (0.40%)  2 0/326 (0.00%)  0 0/300 (0.00%)  0
Device connection issue  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Device damage  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Device electrical impedance issue  1  1/499 (0.20%)  1 1/326 (0.31%)  1 0/300 (0.00%)  0
Device migration  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Device stimulation issue  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Edema extremities  1  2/499 (0.40%)  3 0/326 (0.00%)  0 0/300 (0.00%)  0
Elevated pacing threshold  1  2/499 (0.40%)  2 2/326 (0.61%)  2 1/300 (0.33%)  1
Failure to capture  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Fatigue  1  3/499 (0.60%)  3 1/326 (0.31%)  1 0/300 (0.00%)  0
Impedance increased  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Implant site bleeding  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Implant site bruising  1  2/499 (0.40%)  2 0/326 (0.00%)  0 0/300 (0.00%)  0
Implant site burning  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Implant site edema  1  0/499 (0.00%)  0 1/326 (0.31%)  1 1/300 (0.33%)  1
Implant site erythema  1  1/499 (0.20%)  1 0/326 (0.00%)  0 1/300 (0.33%)  1
Implant site hematoma  1  11/499 (2.20%)  12 5/326 (1.53%)  5 0/300 (0.00%)  0
Implant site irritation  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Implant site numbness  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Implant site pain  1  7/499 (1.40%)  10 4/326 (1.23%)  6 5/300 (1.67%)  5
Inappropriate device stimulation of tissue  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Inappropriate phrenic nerve stimulation  1  18/499 (3.61%)  20 23/326 (7.06%)  27 18/300 (6.00%)  19
Inappropriate stimulation of diaphragm  1  21/499 (4.21%)  23 13/326 (3.99%)  14 8/300 (2.67%)  8
Lead dislodgement  1  4/499 (0.80%)  4 0/326 (0.00%)  0 0/300 (0.00%)  0
Lead impedance abnormally low  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Lead microdislodgement  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Loss of capture  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Non-cardiac chest pain  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Oversensing  1  4/499 (0.80%)  4 0/326 (0.00%)  0 2/300 (0.67%)  2
Pacing threshold increased  1  0/499 (0.00%)  0 3/326 (0.92%)  3 0/300 (0.00%)  0
Phantom shocks  1  2/499 (0.40%)  3 0/326 (0.00%)  0 0/300 (0.00%)  0
Swelling arm  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Tissue erosion associated with device  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Undersensing  1  3/499 (0.60%)  3 0/326 (0.00%)  0 0/300 (0.00%)  0
Weakness worsened  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Wound healing delayed  1  2/499 (0.40%)  2 0/326 (0.00%)  0 0/300 (0.00%)  0
Infections and infestations       
Cellulitis  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Cystitis  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Implant site cellulitis  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Implant site infection  1  1/499 (0.20%)  1 1/326 (0.31%)  1 3/300 (1.00%)  3
Osteomyelitis  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Injury, poisoning and procedural complications       
Anemia postoperative  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Cardiac vein dissection  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Contusion of chest wall  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Coronary sinus dissection  1  1/499 (0.20%)  1 0/326 (0.00%)  0 3/300 (1.00%)  3
Coronary sinus perforation  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Incision site pain  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Opiate toxicity  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Scalp laceration  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Investigations       
Oxygen saturation low  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Raised blood pressure  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Troponin increased  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Metabolism and nutrition disorders       
Fluid overload  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Hyperkalemia  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Hyperlipidemia  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Hypervolemia  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Hypokalemia  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Volume overload  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Chest wall pain  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Musculoskeletal stiffness  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Pain in arm  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Nervous system disorders       
Carotid artery occlusion  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Cerebrovascular accident  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Dizziness  1  1/499 (0.20%)  1 1/326 (0.31%)  1 1/300 (0.33%)  1
Lightheadedness  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Loss of consciousness  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Near syncope  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Paresthesia  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Pre-syncope  1  1/499 (0.20%)  1 1/326 (0.31%)  1 0/300 (0.00%)  0
Syncope  1  1/499 (0.20%)  2 1/326 (0.31%)  1 1/300 (0.33%)  1
Thrombotic stroke  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Vasovagal reaction  1  1/499 (0.20%)  1 1/326 (0.31%)  1 0/300 (0.00%)  0
Psychiatric disorders       
Anxiety  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Renal and urinary disorders       
Acute renal insufficiency  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Chronic kidney disease  1  2/499 (0.40%)  2 0/326 (0.00%)  0 0/300 (0.00%)  0
Nephrosclerosis  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Respiratory, thoracic and mediastinal disorders       
Cheyne-Stokes respiration  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Dyspnea  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Exertional dyspnea  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Hydrothorax  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Paroxysmal nocturnal dyspnea  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Pleural effusion  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Pneumothorax  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Shortness of breath  1  3/499 (0.60%)  3 1/326 (0.31%)  1 1/300 (0.33%)  1
Skin and subcutaneous tissue disorders       
Diaphoresis  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Erythema multiforme type skin reaction  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Itching  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Ulcus cruris  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Venous stasis ulcer  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Vascular disorders       
Abdominal aortic aneurysm  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Aortic stenosis  1  0/499 (0.00%)  0 1/326 (0.31%)  1 0/300 (0.00%)  0
Arterial insufficiency peripheral  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Bleeding varicose vein  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Cardiovascular collapse  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Deep vein thrombosis  1  1/499 (0.20%)  1 0/326 (0.00%)  0 3/300 (1.00%)  3
Hematoma  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Hypertension  1  6/499 (1.20%)  6 0/326 (0.00%)  0 4/300 (1.33%)  4
Hypertension worsened  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Hypotension  1  11/499 (2.20%)  14 2/326 (0.61%)  2 1/300 (0.33%)  1
Low BP  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Orthostatic hypotension  1  3/499 (0.60%)  3 1/326 (0.31%)  1 0/300 (0.00%)  0
Peripheral vascular disease  1  1/499 (0.20%)  1 2/326 (0.61%)  2 0/300 (0.00%)  0
Superior vena cava stenosis  1  1/499 (0.20%)  1 0/326 (0.00%)  0 0/300 (0.00%)  0
Thrombosis  1  0/499 (0.00%)  0 0/326 (0.00%)  0 1/300 (0.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Shelby Li
Organization: Medtronic
Phone: +17635262704
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT01751022     History of Changes
Other Study ID Numbers: Attain Performa(TM)
First Submitted: December 3, 2012
First Posted: December 17, 2012
Results First Submitted: February 29, 2016
Results First Posted: December 5, 2016
Last Update Posted: December 5, 2016