Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Clinical Performance of the Protecta ICD and CRT-D

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: NCT00982397
Recruitment Status : Completed
First Posted : September 23, 2009
Results First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Tachyarrhythmias
Heart Failure
Ventricular Dysfunction
Interventions Device: Protecta VR-ICD
Device: Protecta DR-ICD or CRT-D
Enrollment 2770
Recruitment Details  
Pre-assignment Details Twenty patients were excluded from analysis, because they did not meet the eligibility criteria; 1 patient did not sign consent, 1 patient participated in a confounding trial, 8 patients did not have an implant attempted, 5 patients failed implant, and 5 patients received a device other than the Protecta.Total enrolled=2790, total analyzed=2770
Arm/Group Title DR-ICD/CRT-D VR-ICD
Hide Arm/Group Description Patients implanted with a dual-chamber ICD (DR-ICD) or cardiac resynchronization therapy defibrillator (CRT-D). Patients implanted with a single-chamber ICD (VR-ICD).
Period Title: Phase I
Started 236 0
Completed 236 0
Not Completed 0 0
Period Title: Phase II/Overall Study
Started [1] 2019 751
Secondary Prevention Randomized 18/24NID [2] 231 122
Secondary Prevention Randomized 30/40NID [2] 221 131
Completed 2019 751
Not Completed 0 0
[1]
Note additional subjects were enrolled for Phase II
[2]
NID=number of intervals to detect prior to therapy delivery
Arm/Group Title DR-ICD/CRT-D VR-ICD Total
Hide Arm/Group Description Patients implanted with a dual-chamber ICD (DR-ICD) or cardiac resynchronization therapy defibrillator (CRT-D). Patients implanted with a single-chamber ICD (VR-ICD). Total of all reporting groups
Overall Number of Baseline Participants 2019 751 2770
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2019 participants 751 participants 2770 participants
65.9  (12.1) 61.9  (12.1) 64.8  (12.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2019 participants 751 participants 2770 participants
Female
430
  21.3%
140
  18.6%
570
  20.6%
Male
1589
  78.7%
611
  81.4%
2200
  79.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2019 participants 751 participants 2770 participants
Austria 44 14 58
Canada 119 145 264
Colombia 18 4 22
Czech Republic 33 30 63
Denmark 60 42 102
Germany 248 57 305
India 7 18 25
Israel 104 58 162
Italy 61 11 72
Japan 144 37 181
Malaysia 17 2 19
Netherlands 154 86 240
Saudi Arabia 121 43 164
Slovenia 15 0 15
South Africa 7 0 7
Spain 24 30 54
Sweden 17 3 20
Switzerland 13 0 13
United Arab Emirates 1 4 5
United Kingdom 103 11 114
United States 709 156 865
LVEF  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 2019 participants 751 participants 2770 participants
31.8  (13.0) 33.3  (13.5) 32.2  (13.2)
QRS  
Mean (Standard Deviation)
Unit of measure:  Ms
Number Analyzed 2019 participants 751 participants 2770 participants
133.7  (33.7) 107.1  (21.9) 125.9  (33.0)
Indication   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2019 participants 751 participants 2770 participants
Secondary Prevention 593 254 847
Primary Prevention 1426 497 1923
[1]
Measure Description:

Primary prevention is an ICD indication to prevent sudden cardiac death. It refers to use of ICDs in individuals who are at risk for, but have not yet had, an episode of sustained VT, VF, or cardiac arrest.

Secondary prevention refers to an ICD indication for patients who have survived 1 or more cardiac arrests or sustained ventricular tachycardia. Patients with cardiac conditions associated with a high risk of sudden death who have unexplained syncope that is likely to be due to self-terminating ventricular arrhythmias are also considered to have a secondary prevention indication.

Heart Failure Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2019 participants 751 participants 2770 participants
NYHA I 232 187 419
NYHA II 758 346 1104
NYHA III 754 99 853
NYHA IV 30 8 38
No Heart Failure 245 109 354
Unknown 0 2 2
[1]
Measure Description:

NYHA Class I-No limitation of physical activity. NYHA Class II-Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).

NYHA Class III-Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.

NYHA Class IV-Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.

1.Primary Outcome
Title Percentage of Subjects Who Are Inappropriate Shock Free
Hide Description Primary objective of Phase II. Subjects implanted with a VR device will be analyzed separately from subjects implanted with a DR / CRT-D device. An inappropriate shock is a shock delivered by the defibrillator when the patient's heart rhythm was not a tachyarrhythmia, as adjudicated by the independent Episode Review Committee .
Time Frame Implant to one year post-implant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DR-ICD/CRT-D VR-ICD
Hide Arm/Group Description:
Patients implanted with a dual-chamber ICD (DR-ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
Patients implanted with a single-chamber ICD (VR-ICD).
Overall Number of Participants Analyzed 2019 751
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
98.5
(97.9 to 99.0)
97.5
(96.1 to 98.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DR-ICD/CRT-D
Comments The study was designed to include at least 1,131 patients with DR/CRT-D ICD devices in order to estimate the inappropriate shock free rate at 1 year post-implant with 1% precision.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants
Estimated Value 98.5
Confidence Interval (2-Sided) 95%
97.9 to 99.0
Estimation Comments Therapy rates were analyzed using competing risks survival analysis methods, accounting for death as a competing risk.Therapy incidence rates were estimated using cumulative incidence functions and reported with 95% confidence interval.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VR-ICD
Comments This study was designed to include at least 610 patients with VR-ICD devices in order to estimate the inappropriate shock free rate at 1 year post-implant with a precision of 2%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants
Estimated Value 97.5
Confidence Interval (2-Sided) 95%
96.1 to 98.5
Estimation Comments Therapy rates were analyzed using competing risks survival analysis methods, accounting for death as a competing risk.Therapy incidence rates were estimated using cumulative incidence functions and reported with 95% confidence interval.
2.Primary Outcome
Title Percentage of Subjects With Unanticipated Severe Adverse Device Effects (Phase I)
Hide Description In Phase I, only DR-ICD/CRT-D devices were implanted, so that for Phase I objectives there is only 1 arm to report results for.
Time Frame Implant to one month post-implant
Hide Outcome Measure Data
Hide Analysis Population Description
Phase I subjects (a subset of the total number of subjects) implanted with a Protecta device with at least 30 days of follow-up or a USADE within the first 30 days post-implant are included in this analysis. One hundred subjects met the criteria above and are included in the analysis.
Arm/Group Title Phase I
Hide Arm/Group Description:
Subjects enrolled in Phase I of the study (Protecta).
Overall Number of Participants Analyzed 100
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
0 [1] 
(NA to 3.0)
[1]
As specified in the protocol and analysis plan, only a one-sided 95% binomial upper confidence bound is used.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase I
Comments Using the one-sided one proportion Exact Test in PASS sample size software, a sample size of 76 subjects with 1-month follow-up was calculated to be required for the evaluation of this objective. To ensure adequate testing of the Protecta XT CRT-D device, the 76 subjects must have included at least 34 CRT-D subjects. Assuming an attrition rate of 10%, a sample size of 85 subjects enrolled was calculated to be required.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is for comparison against a performance criterion of 10%.
Method Exact Binomial
Comments [Not Specified]
3.Primary Outcome
Title Percentage of Phase I Subjects Where the Ventricular Fibrillation (VF) Detection Time With Protecta Features on is no More Than 2 Seconds Longer Than the VF Detection Time With Protecta Features Off
Hide Description In Phase I, only DR-ICD/CRT-D devices were implanted, so that for Phase I objectives there is only 1 arm to report results for.
Time Frame At implant
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 236 subjects implanted, 40 subjects / episodes were classified as not useable. In Phase I, only DR-ICD/CRT-D devices were implanted, so that for Phase I objectives there is only 1 arm to report results for.
Arm/Group Title Phase I
Hide Arm/Group Description:
Subjects enrolled in Phase I of the study (Protecta).
Overall Number of Participants Analyzed 196
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: percentage of patients
100 [1] 
(98.1 to NA)
[1]
As specified in the protocol and analysis plan, a one-side lower confidence bound was used.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase I
Comments P, the expected proportion of successes under the null hypothesis, was 95%. α, the Type I error rate, is 0.025. Power is 90%. Pa, the assumed true proportion of successes, is 99%. Based on the above assumptions, at least 173 subjects with a useable time to VF detection testing were required for this objective. Assuming a 5% rate for the potential non-adherence to the testing protocol, the required enrollment sample size was 183.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is for comparison of the observed proportion of successes against a protocol-specified performance criterion of 95%.
Method Confidence interval and hypothesis test
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Secondary Prevention Subjects Who Are Syncopal Event Free
Hide Description [Not Specified]
Time Frame Implant to one year post-implant
Hide Outcome Measure Data
Hide Analysis Population Description
Includes randomized secondary prevention patients from Phase II.
Arm/Group Title 18/24 NID 30/40 NID
Hide Arm/Group Description:
Secondary prevention subjects in Phase II randomized to 18/24 NID. (18/24 NID indicates the number of intervals used to detect VF was programmed to 18 of 24 intervals).
Secondary prevention subjects in Phase II randomized to 30/40 NID. (30/40 NID indicates the number of intervals used to detect VF was programmed to 30 of 40 intervals).
Overall Number of Participants Analyzed 353 352
Measure Type: Number
Unit of Measure: percentage of patients
96 96
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 18/24 NID, 30/40 NID
Comments The expected syncopal event free rate was 0.984 in both programming groups. alpha, Type I error was 0.05. Power, 1-beta, was 80%. Non-inferiority margin 5% Based on the above assumptions and Farrington-Manning test, a total of 230 subjects was required. By further assuming 15% attrition rate and 5 % of crossover rate, a total of 300 subjects were needed.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Ho: p1 ≤ p2 - 0.05 Ha: p1 > p2 - 0.05 Where p1 was the syncopal event free rate at one year post implant by programming VF NID 30/40 and p2 for NID = 18/24. If the null-hypothesis was rejected it was concluded that NID = 30/40 did not decrease the syncope free rate by more than 5% compared to NID = 18/24 and hence was non-inferior.
Statistical Test of Hypothesis P-Value 0.0013
Comments P-Value is for non-inferiority
Method Farrington-Manning
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0
Confidence Interval (2-Sided) 90%
-2.7 to 2.7
Estimation Comments The 90% Confidence Interval is for the difference (p1-p2), where p1=syncope free rate 30/40 arm and p2=syncope free rate 18/24 arm. Estimated value and confidence interval reflect percentages.
Time Frame Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Adverse Event Reporting Description Other (non-serious) AE data were not collected for this study.
 
Arm/Group Title DR-ICD/CRT-D VR-ICD
Hide Arm/Group Description Patients implanted with a dual-chamber ICD (DR-ICD) or cardiac resynchronization therapy defibrillator (CRT-D). Patients implanted with a single-chamber ICD (VR-ICD).
All-Cause Mortality
DR-ICD/CRT-D VR-ICD
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
DR-ICD/CRT-D VR-ICD
Affected / at Risk (%) Affected / at Risk (%)
Total   452/2019 (22.39%)   125/751 (16.64%) 
Blood and lymphatic system disorders     
Anaemia  1  8/2019 (0.40%)  1/751 (0.13%) 
Anaemia of malignant disease  1  1/2019 (0.05%)  0/751 (0.00%) 
Leukocytosis  1  1/2019 (0.05%)  0/751 (0.00%) 
Pancytopenia  1  1/2019 (0.05%)  0/751 (0.00%) 
Spontaneous haematoma  1  1/2019 (0.05%)  0/751 (0.00%) 
Cardiac disorders     
Acute coronary syndrome  1  1/2019 (0.05%)  2/751 (0.27%) 
Acute myocardial infarction  1  8/2019 (0.40%)  3/751 (0.40%) 
Angina pectoris  1  19/2019 (0.94%)  4/751 (0.53%) 
Angina unstable  1  6/2019 (0.30%)  2/751 (0.27%) 
Arrhythmia supraventricular  1  1/2019 (0.05%)  0/751 (0.00%) 
Arteriosclerosis coronary artery  1  1/2019 (0.05%)  0/751 (0.00%) 
Atrial fibrillation  1  33/2019 (1.63%)  4/751 (0.53%) 
Atrial flutter  1  10/2019 (0.50%)  2/751 (0.27%) 
Atrial tachycardia  1  2/2019 (0.10%)  2/751 (0.27%) 
Bradycardia  1  1/2019 (0.05%)  0/751 (0.00%) 
Cardiac arrest  1  7/2019 (0.35%)  0/751 (0.00%) 
Cardiac failure  1  108/2019 (5.35%)  29/751 (3.86%) 
Cardiac failure acute  1  1/2019 (0.05%)  1/751 (0.13%) 
Cardiac failure chronic  1  4/2019 (0.20%)  0/751 (0.00%) 
Cardiac failure congestive  1  6/2019 (0.30%)  2/751 (0.27%) 
Cardiac perforation  1  1/2019 (0.05%)  0/751 (0.00%) 
Cardiogenic shock  1  1/2019 (0.05%)  0/751 (0.00%) 
Coronary artery disease  1  1/2019 (0.05%)  3/751 (0.40%) 
Coronary artery occlusion  1  1/2019 (0.05%)  0/751 (0.00%) 
Coronary artery stenosis  1  1/2019 (0.05%)  1/751 (0.13%) 
Extrasystoles  1  1/2019 (0.05%)  0/751 (0.00%) 
Heart valve incompetence  1  0/2019 (0.00%)  2/751 (0.27%) 
Hypertrophic cardiomyopathy  1  2/2019 (0.10%)  0/751 (0.00%) 
Ischaemic cardiomyopathy  1  1/2019 (0.05%)  1/751 (0.13%) 
Mitral valve disease mixed  1  0/2019 (0.00%)  1/751 (0.13%) 
Mitral valve incompetence  1  2/2019 (0.10%)  2/751 (0.27%) 
Myocardial infarction  1  4/2019 (0.20%)  0/751 (0.00%) 
Palpitations  1  2/2019 (0.10%)  0/751 (0.00%) 
Pericardial effusion  1  2/2019 (0.10%)  0/751 (0.00%) 
Pericarditis  1  1/2019 (0.05%)  0/751 (0.00%) 
Pulseless electrical activity  1  1/2019 (0.05%)  0/751 (0.00%) 
Sinus tachycardia  1  0/2019 (0.00%)  1/751 (0.13%) 
Supraventricular tachycardia  1  1/2019 (0.05%)  0/751 (0.00%) 
Tachycardia  1  2/2019 (0.10%)  0/751 (0.00%) 
Torsade de pointes  1  1/2019 (0.05%)  0/751 (0.00%) 
Ventricular arrhythmia  1  5/2019 (0.25%)  1/751 (0.13%) 
Ventricular fibrillation  1  5/2019 (0.25%)  2/751 (0.27%) 
Ventricular tachyarrhythmia  1  6/2019 (0.30%)  1/751 (0.13%) 
Ventricular tachycardia  1  40/2019 (1.98%)  14/751 (1.86%) 
Congenital, familial and genetic disorders     
Atrial septal defect  1  1/2019 (0.05%)  0/751 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  1/2019 (0.05%)  0/751 (0.00%) 
Endocrine disorders     
Hyperparathyroidism tertiary  1  1/2019 (0.05%)  0/751 (0.00%) 
Hyperthyroidism  1  1/2019 (0.05%)  0/751 (0.00%) 
Eye disorders     
Retinal detachment  1  0/2019 (0.00%)  1/751 (0.13%) 
Retinopathy proliferative  1  1/2019 (0.05%)  0/751 (0.00%) 
Gastrointestinal disorders     
Abdominal hernia  1  1/2019 (0.05%)  0/751 (0.00%) 
Abdominal pain  1  1/2019 (0.05%)  0/751 (0.00%) 
Abdominal pain upper  1  1/2019 (0.05%)  0/751 (0.00%) 
Abdominal wall haemorrhage  1  1/2019 (0.05%)  0/751 (0.00%) 
Colitis  1  1/2019 (0.05%)  0/751 (0.00%) 
Colitis ischaemic  1  1/2019 (0.05%)  0/751 (0.00%) 
Colonic polyp  1  1/2019 (0.05%)  0/751 (0.00%) 
Constipation  1  1/2019 (0.05%)  0/751 (0.00%) 
Diarrhoea  1  0/2019 (0.00%)  1/751 (0.13%) 
Duodenal ulcer  1  0/2019 (0.00%)  1/751 (0.13%) 
Dyspepsia  1  1/2019 (0.05%)  0/751 (0.00%) 
Enteritis  1  2/2019 (0.10%)  0/751 (0.00%) 
Gastritis  1  1/2019 (0.05%)  0/751 (0.00%) 
Gastrointestinal haemorrhage  1  6/2019 (0.30%)  0/751 (0.00%) 
Ileus  1  1/2019 (0.05%)  0/751 (0.00%) 
Inguinal hernia  1  1/2019 (0.05%)  0/751 (0.00%) 
Pancreatitis  1  1/2019 (0.05%)  0/751 (0.00%) 
Pancreatitis acute  1  1/2019 (0.05%)  0/751 (0.00%) 
Polyp colorectal  1  1/2019 (0.05%)  0/751 (0.00%) 
Rectal haemorrhage  1  0/2019 (0.00%)  1/751 (0.13%) 
Umbilical hernia  1  1/2019 (0.05%)  0/751 (0.00%) 
Upper gastrointestinal haemorrhage  1  1/2019 (0.05%)  1/751 (0.13%) 
General disorders     
Adverse drug reaction  1  0/2019 (0.00%)  2/751 (0.27%) 
Asthenia  1  1/2019 (0.05%)  1/751 (0.13%) 
Catheter site haemorrhage  1  1/2019 (0.05%)  0/751 (0.00%) 
Chest pain  1  14/2019 (0.69%)  4/751 (0.53%) 
Death  1  5/2019 (0.25%)  3/751 (0.40%) 
Device battery issue  1  1/2019 (0.05%)  0/751 (0.00%) 
Device capturing issue  1  1/2019 (0.05%)  0/751 (0.00%) 
Device dislocation  1  32/2019 (1.58%)  3/751 (0.40%) 
Device electrical impedance issue  1  2/2019 (0.10%)  0/751 (0.00%) 
Device extrusion  1  1/2019 (0.05%)  0/751 (0.00%) 
Device failure  1  1/2019 (0.05%)  0/751 (0.00%) 
Device issue  1  1/2019 (0.05%)  0/751 (0.00%) 
Device lead damage  1  9/2019 (0.45%)  2/751 (0.27%) 
Device lead issue  1  3/2019 (0.15%)  3/751 (0.40%) 
Device malfunction  1  1/2019 (0.05%)  0/751 (0.00%) 
Device misuse  1  8/2019 (0.40%)  2/751 (0.27%) 
Device pacing issue  1  5/2019 (0.25%)  0/751 (0.00%) 
Device stimulation issue  1  2/2019 (0.10%)  0/751 (0.00%) 
General physical health deterioration  1  2/2019 (0.10%)  0/751 (0.00%) 
Hypothermia  1  1/2019 (0.05%)  0/751 (0.00%) 
Impaired healing  1  1/2019 (0.05%)  0/751 (0.00%) 
Implant site haematoma  1  4/2019 (0.20%)  0/751 (0.00%) 
Implant site pain  1  3/2019 (0.15%)  2/751 (0.27%) 
Multi-organ failure  1  3/2019 (0.15%)  0/751 (0.00%) 
Oedema  1  1/2019 (0.05%)  0/751 (0.00%) 
Oversensing  1  3/2019 (0.15%)  1/751 (0.13%) 
Pyrexia  1  4/2019 (0.20%)  1/751 (0.13%) 
Sudden cardiac death  1  0/2019 (0.00%)  1/751 (0.13%) 
Undersensing  1  1/2019 (0.05%)  0/751 (0.00%) 
  1 [1]  4/2019 (0.20%)  2/751 (0.27%) 
Hepatobiliary disorders     
Bile duct stone  1  1/2019 (0.05%)  0/751 (0.00%) 
Cholelithiasis  1  1/2019 (0.05%)  0/751 (0.00%) 
Hepatic haemorrhage  1  1/2019 (0.05%)  0/751 (0.00%) 
Hepatitis  1  1/2019 (0.05%)  0/751 (0.00%) 
Liver disorder  1  0/2019 (0.00%)  1/751 (0.13%) 
Infections and infestations     
Appendicitis  1  1/2019 (0.05%)  0/751 (0.00%) 
Arthritis bacterial  1  1/2019 (0.05%)  0/751 (0.00%) 
Arthritis infective  1  1/2019 (0.05%)  0/751 (0.00%) 
Bacteraemia  1  1/2019 (0.05%)  1/751 (0.13%) 
Bronchitis  1  2/2019 (0.10%)  0/751 (0.00%) 
Bronchitis viral  1  1/2019 (0.05%)  0/751 (0.00%) 
Cellulitis  1  1/2019 (0.05%)  0/751 (0.00%) 
Device related infection  1  0/2019 (0.00%)  1/751 (0.13%) 
Diverticulitis  1  1/2019 (0.05%)  0/751 (0.00%) 
Endocarditis  1  6/2019 (0.30%)  1/751 (0.13%) 
Endocarditis bacterial  1  2/2019 (0.10%)  0/751 (0.00%) 
Erysipelas  1  3/2019 (0.15%)  1/751 (0.13%) 
Gangrene  1  2/2019 (0.10%)  1/751 (0.13%) 
Gastroenteritis  1  3/2019 (0.15%)  1/751 (0.13%) 
Implant site abscess  1  1/2019 (0.05%)  0/751 (0.00%) 
Implant site infection  1  9/2019 (0.45%)  4/751 (0.53%) 
Infection  1  7/2019 (0.35%)  0/751 (0.00%) 
Lower respiratory tract infection  1  3/2019 (0.15%)  1/751 (0.13%) 
Orchitis  1  1/2019 (0.05%)  0/751 (0.00%) 
Pleural infection  1  1/2019 (0.05%)  0/751 (0.00%) 
Pneumococcal sepsis  1  1/2019 (0.05%)  1/751 (0.13%) 
Pneumonia  1  21/2019 (1.04%)  6/751 (0.80%) 
Pneumonia primary atypical  1  1/2019 (0.05%)  0/751 (0.00%) 
Post procedural infection  1  1/2019 (0.05%)  0/751 (0.00%) 
Sepsis  1  6/2019 (0.30%)  1/751 (0.13%) 
Sinusitis  1  1/2019 (0.05%)  0/751 (0.00%) 
Tuberculosis  1  0/2019 (0.00%)  2/751 (0.27%) 
Upper respiratory tract infection  1  1/2019 (0.05%)  1/751 (0.13%) 
Urinary tract infection  1  7/2019 (0.35%)  1/751 (0.13%) 
Urosepsis  1  1/2019 (0.05%)  0/751 (0.00%) 
Viral infection  1  0/2019 (0.00%)  1/751 (0.13%) 
Wound infection  1  2/2019 (0.10%)  0/751 (0.00%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  1/2019 (0.05%)  0/751 (0.00%) 
Cardiac vein dissection  1  1/2019 (0.05%)  0/751 (0.00%) 
Clavicle fracture  1  1/2019 (0.05%)  0/751 (0.00%) 
Concussion  1  1/2019 (0.05%)  0/751 (0.00%) 
Contusion  1  1/2019 (0.05%)  0/751 (0.00%) 
Fall  1  1/2019 (0.05%)  1/751 (0.13%) 
Femoral neck fracture  1  2/2019 (0.10%)  0/751 (0.00%) 
Femur fracture  1  4/2019 (0.20%)  2/751 (0.27%) 
Hip fracture  1  2/2019 (0.10%)  1/751 (0.13%) 
Humerus fracture  1  1/2019 (0.05%)  0/751 (0.00%) 
In-stent arterial restenosis  1  0/2019 (0.00%)  1/751 (0.13%) 
In-stent coronary artery restenosis  1  0/2019 (0.00%)  1/751 (0.13%) 
Lumbar vertebral fracture  1  1/2019 (0.05%)  0/751 (0.00%) 
Multiple injuries  1  0/2019 (0.00%)  1/751 (0.13%) 
Overdose  1  1/2019 (0.05%)  0/751 (0.00%) 
Pocket erosion  1  1/2019 (0.05%)  0/751 (0.00%) 
Post procedural haemorrhage  1  1/2019 (0.05%)  0/751 (0.00%) 
Skull fracture  1  1/2019 (0.05%)  0/751 (0.00%) 
Spinal fracture  1  1/2019 (0.05%)  0/751 (0.00%) 
Subcutaneous haematoma  1  1/2019 (0.05%)  0/751 (0.00%) 
Subdural haematoma  1  1/2019 (0.05%)  1/751 (0.13%) 
Tendon rupture  1  1/2019 (0.05%)  0/751 (0.00%) 
Tibia fracture  1  1/2019 (0.05%)  0/751 (0.00%) 
Upper limb fracture  1  4/2019 (0.20%)  0/751 (0.00%) 
Vascular pseudoaneurysm  1  0/2019 (0.00%)  1/751 (0.13%) 
Wound  1  1/2019 (0.05%)  0/751 (0.00%) 
Wound secretion  1  1/2019 (0.05%)  0/751 (0.00%) 
Investigations     
Arteriogram coronary  1  4/2019 (0.20%)  1/751 (0.13%) 
Blood creatinine increased  1  1/2019 (0.05%)  0/751 (0.00%) 
Blood glucose increased  1  1/2019 (0.05%)  0/751 (0.00%) 
Blood pressure abnormal  1  1/2019 (0.05%)  0/751 (0.00%) 
Catheterisation cardiac  1  1/2019 (0.05%)  0/751 (0.00%) 
Colonoscopy  1  0/2019 (0.00%)  1/751 (0.13%) 
Investigation  1  2/2019 (0.10%)  1/751 (0.13%) 
Liver function test abnormal  1  1/2019 (0.05%)  0/751 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  3/2019 (0.15%)  2/751 (0.27%) 
Diabetes mellitus  1  1/2019 (0.05%)  0/751 (0.00%) 
Diabetic foot  1  1/2019 (0.05%)  0/751 (0.00%) 
Hyperglycaemia  1  1/2019 (0.05%)  0/751 (0.00%) 
Hyperkalaemia  1  0/2019 (0.00%)  2/751 (0.27%) 
Hypoglycaemia  1  1/2019 (0.05%)  0/751 (0.00%) 
Hyponatraemia  1  1/2019 (0.05%)  0/751 (0.00%) 
Type 2 diabetes mellitus  1  1/2019 (0.05%)  1/751 (0.13%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  2/2019 (0.10%)  0/751 (0.00%) 
Fistula  1  1/2019 (0.05%)  0/751 (0.00%) 
Lumbar spinal stenosis  1  1/2019 (0.05%)  0/751 (0.00%) 
Musculoskeletal chest pain  1  1/2019 (0.05%)  0/751 (0.00%) 
Osteoarthritis  1  1/2019 (0.05%)  2/751 (0.27%) 
Pain in extremity  1  3/2019 (0.15%)  0/751 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  1/2019 (0.05%)  0/751 (0.00%) 
Bladder cancer  1  0/2019 (0.00%)  1/751 (0.13%) 
Colon adenoma  1  1/2019 (0.05%)  1/751 (0.13%) 
Colon cancer  1  0/2019 (0.00%)  1/751 (0.13%) 
Gastrointestinal carcinoma  1  1/2019 (0.05%)  0/751 (0.00%) 
Hepatic neoplasm malignant  1  1/2019 (0.05%)  0/751 (0.00%) 
Hepatic neoplasm malignant non-resectable  1  1/2019 (0.05%)  0/751 (0.00%) 
Intracranial meningioma malignant  1  1/2019 (0.05%)  0/751 (0.00%) 
Leukaemia  1  1/2019 (0.05%)  0/751 (0.00%) 
Lung neoplasm malignant  1  2/2019 (0.10%)  1/751 (0.13%) 
Myeloid leukaemia  1  1/2019 (0.05%)  0/751 (0.00%) 
Myeloproliferative disorder  1  1/2019 (0.05%)  0/751 (0.00%) 
Neoplasm  1  2/2019 (0.10%)  0/751 (0.00%) 
Neoplasm malignant  1  2/2019 (0.10%)  1/751 (0.13%) 
Non-Hodgkin's lymphoma  1  1/2019 (0.05%)  0/751 (0.00%) 
Non-Hodgkin's lymphoma stage IV  1  1/2019 (0.05%)  0/751 (0.00%) 
Pancreatic carcinoma  1  1/2019 (0.05%)  0/751 (0.00%) 
Prostate cancer  1  2/2019 (0.10%)  0/751 (0.00%) 
Rectosigmoid cancer  1  0/2019 (0.00%)  1/751 (0.13%) 
Renal cancer  1  3/2019 (0.15%)  0/751 (0.00%) 
Seminoma  1  0/2019 (0.00%)  1/751 (0.13%) 
Transitional cell carcinoma  1  1/2019 (0.05%)  0/751 (0.00%) 
Nervous system disorders     
Cerebral haemorrhage  1  1/2019 (0.05%)  0/751 (0.00%) 
Cerebral infarction  1  1/2019 (0.05%)  0/751 (0.00%) 
Cerebrovascular accident  1  8/2019 (0.40%)  1/751 (0.13%) 
Cerebrovascular disorder  1  1/2019 (0.05%)  0/751 (0.00%) 
Cognitive disorder  1  0/2019 (0.00%)  1/751 (0.13%) 
Convulsion  1  1/2019 (0.05%)  0/751 (0.00%) 
Dementia  1  0/2019 (0.00%)  1/751 (0.13%) 
Dizziness  1  3/2019 (0.15%)  0/751 (0.00%) 
Epilepsy  1  1/2019 (0.05%)  0/751 (0.00%) 
Hemiparesis  1  1/2019 (0.05%)  0/751 (0.00%) 
Hypokinesia  1  1/2019 (0.05%)  0/751 (0.00%) 
Hypotonia  1  1/2019 (0.05%)  0/751 (0.00%) 
Ischaemic stroke  1  2/2019 (0.10%)  1/751 (0.13%) 
Loss of consciousness  1  1/2019 (0.05%)  0/751 (0.00%) 
Presyncope  1  0/2019 (0.00%)  1/751 (0.13%) 
Syncope  1  18/2019 (0.89%)  3/751 (0.40%) 
Transient ischaemic attack  1  5/2019 (0.25%)  0/751 (0.00%) 
Psychiatric disorders     
Alcohol abuse  1  1/2019 (0.05%)  0/751 (0.00%) 
Anxiety  1  1/2019 (0.05%)  0/751 (0.00%) 
Depression  1  0/2019 (0.00%)  1/751 (0.13%) 
Psychotic disorder due to a general medical condition  1  1/2019 (0.05%)  0/751 (0.00%) 
Renal and urinary disorders     
Haematuria  1  3/2019 (0.15%)  1/751 (0.13%) 
Nephritis  1  1/2019 (0.05%)  0/751 (0.00%) 
Nephrolithiasis  1  1/2019 (0.05%)  0/751 (0.00%) 
Nephropathy  1  4/2019 (0.20%)  0/751 (0.00%) 
Renal failure  1  4/2019 (0.20%)  1/751 (0.13%) 
Renal failure acute  1  4/2019 (0.20%)  3/751 (0.40%) 
Renal failure chronic  1  2/2019 (0.10%)  0/751 (0.00%) 
Renal infarct  1  1/2019 (0.05%)  0/751 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/2019 (0.05%)  0/751 (0.00%) 
Postmenopausal haemorrhage  1  1/2019 (0.05%)  0/751 (0.00%) 
Rectocele  1  1/2019 (0.05%)  0/751 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  2/2019 (0.10%)  0/751 (0.00%) 
Brain hypoxia  1  1/2019 (0.05%)  0/751 (0.00%) 
Bronchitis chronic  1  1/2019 (0.05%)  0/751 (0.00%) 
Chronic obstructive pulmonary disease  1  8/2019 (0.40%)  2/751 (0.27%) 
Dyspnoea  1  17/2019 (0.84%)  3/751 (0.40%) 
Epiglottis ulcer  1  1/2019 (0.05%)  0/751 (0.00%) 
Epistaxis  1  3/2019 (0.15%)  2/751 (0.27%) 
Haemoptysis  1  1/2019 (0.05%)  0/751 (0.00%) 
Haemothorax  1  1/2019 (0.05%)  0/751 (0.00%) 
Hiccups  1  1/2019 (0.05%)  0/751 (0.00%) 
Pleural effusion  1  2/2019 (0.10%)  0/751 (0.00%) 
Pleurisy  1  1/2019 (0.05%)  0/751 (0.00%) 
Pneumothorax  1  6/2019 (0.30%)  2/751 (0.27%) 
Pulmonary congestion  1  2/2019 (0.10%)  0/751 (0.00%) 
Pulmonary embolism  1  0/2019 (0.00%)  1/751 (0.13%) 
Pulmonary fibrosis  1  1/2019 (0.05%)  0/751 (0.00%) 
Pulmonary hypertension  1  2/2019 (0.10%)  0/751 (0.00%) 
Pulmonary oedema  1  1/2019 (0.05%)  1/751 (0.13%) 
Respiratory acidosis  1  1/2019 (0.05%)  0/751 (0.00%) 
Respiratory failure  1  1/2019 (0.05%)  1/751 (0.13%) 
Sleep apnoea syndrome  1  2/2019 (0.10%)  3/751 (0.40%) 
Vocal cord polyp  1  1/2019 (0.05%)  0/751 (0.00%) 
Skin and subcutaneous tissue disorders     
Decubitus ulcer  1  1/2019 (0.05%)  0/751 (0.00%) 
Dermatitis  1  1/2019 (0.05%)  0/751 (0.00%) 
Skin ulcer  1  0/2019 (0.00%)  1/751 (0.13%) 
Surgical and medical procedures     
Adrenalectomy  1  1/2019 (0.05%)  0/751 (0.00%) 
Cardiac ablation  1  1/2019 (0.05%)  0/751 (0.00%) 
Central venous catheter removal  1  1/2019 (0.05%)  0/751 (0.00%) 
Corneal transplant  1  1/2019 (0.05%)  0/751 (0.00%) 
Coronary artery bypass  1  1/2019 (0.05%)  0/751 (0.00%) 
Gastrectomy  1  1/2019 (0.05%)  0/751 (0.00%) 
Heart transplant  1  3/2019 (0.15%)  0/751 (0.00%) 
High frequency ablation  1  3/2019 (0.15%)  0/751 (0.00%) 
Hip arthroplasty  1  1/2019 (0.05%)  0/751 (0.00%) 
Hospitalisation  1  0/2019 (0.00%)  1/751 (0.13%) 
Indwelling catheter management  1  1/2019 (0.05%)  0/751 (0.00%) 
Knee arthroplasty  1  2/2019 (0.10%)  0/751 (0.00%) 
Medical device change  1  11/2019 (0.54%)  0/751 (0.00%) 
Medical device implantation  1  0/2019 (0.00%)  2/751 (0.27%) 
Neurostimulator implantation  1  1/2019 (0.05%)  0/751 (0.00%) 
Radiotherapy  1  0/2019 (0.00%)  1/751 (0.13%) 
Toe amputation  1  1/2019 (0.05%)  1/751 (0.13%) 
Transurethral bladder resection  1  1/2019 (0.05%)  0/751 (0.00%) 
Urethral repair  1  1/2019 (0.05%)  0/751 (0.00%) 
Vertebra dislocation reduction  1  1/2019 (0.05%)  0/751 (0.00%) 
Vertebroplasty  1  1/2019 (0.05%)  0/751 (0.00%) 
Vascular disorders     
Aortic aneurysm  1  1/2019 (0.05%)  0/751 (0.00%) 
Aortic stenosis  1  1/2019 (0.05%)  0/751 (0.00%) 
Arterial occlusive disease  1  1/2019 (0.05%)  0/751 (0.00%) 
Arteriovenous fistula  1  1/2019 (0.05%)  0/751 (0.00%) 
Artery dissection  1  1/2019 (0.05%)  0/751 (0.00%) 
Deep vein thrombosis  1  1/2019 (0.05%)  0/751 (0.00%) 
Embolism arterial  1  1/2019 (0.05%)  0/751 (0.00%) 
Femoral artery occlusion  1  0/2019 (0.00%)  2/751 (0.27%) 
Haematoma  1  1/2019 (0.05%)  0/751 (0.00%) 
Hypertension  1  3/2019 (0.15%)  0/751 (0.00%) 
Hypertensive crisis  1  1/2019 (0.05%)  0/751 (0.00%) 
Hypotension  1  2/2019 (0.10%)  1/751 (0.13%) 
Hypovolaemic shock  1  2/2019 (0.10%)  0/751 (0.00%) 
Iliac artery stenosis  1  1/2019 (0.05%)  0/751 (0.00%) 
Leriche syndrome  1  1/2019 (0.05%)  0/751 (0.00%) 
Peripheral arterial occlusive disease  1  10/2019 (0.50%)  2/751 (0.27%) 
Peripheral ischaemia  1  2/2019 (0.10%)  0/751 (0.00%) 
Peripheral vascular disorder  1  2/2019 (0.10%)  0/751 (0.00%) 
Subclavian vein thrombosis  1  1/2019 (0.05%)  0/751 (0.00%) 
Thrombophlebitis  1  2/2019 (0.10%)  0/751 (0.00%) 
Thrombosis  1  1/2019 (0.05%)  0/751 (0.00%) 
Vasculitis  1  1/2019 (0.05%)  0/751 (0.00%) 
Venous thrombosis  1  0/2019 (0.00%)  1/751 (0.13%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
[1]
Details not available.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
DR-ICD/CRT-D VR-ICD
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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.
In most cases, contracts allow investigators ("PI") to publish per the publication strategy/Clinical Investigation Plan following Medtronic's review for (a) disclosure of confidential information ("CI"), and (b) selection and order of publications by the publications committee. Any such CI is deleted prior to publication/presentation. Medtronic may not otherwise censor/interfere with the publication. PIs may not publish single-site data until the main multi-site publication has occurred.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: CRHF Clinical Research
Organization: Medtronic, plc
Phone: 800-328-2518
EMail: medtroniccrmtrials@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT00982397    
Other Study ID Numbers: PainFree SST
First Submitted: September 22, 2009
First Posted: September 23, 2009
Results First Submitted: May 25, 2016
Results First Posted: November 6, 2017
Last Update Posted: November 6, 2017