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Trial record 49 of 6392 for:    zero

Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation (ZERO-AF)

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: NCT01687166
Recruitment Status : Completed
First Posted : September 18, 2012
Results First Posted : June 18, 2018
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Paroxysmal Atrial Fibrillation (PAF)
Interventions Device: Blazer Open-Irrigated Ablation Catheter (Boston Scientific)
Device: FDA Approved Open-Irrigated Ablation Catheter
Enrollment 398
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Blazer Open-Irrigated Ablation Catheter Control Blazer Open-Irrigated Ablation Catheter Roll-In Control Roll-In
Hide Arm/Group Description

Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system

Blazer Open-Irrigated Ablation Catheter (Boston Scientific)

FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.

FDA Approved Open-Irrigated Ablation Catheter

Blazer Open-Irrigated Ablation Catheter Roll-In Subjects (Not randomized)

Non-Randomized Subjects treated with an FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.

FDA Approved Open-Irrigated Ablation Catheter

Period Title: Overall Study
Started 167 172 56 3
Completed 139 145 42 1
Not Completed 28 27 14 2
Reason Not Completed
Attempt subject             2             3             2             0
Did not meet eligibility criteria             4             6             1             1
Adverse Event             2             1             0             0
Physician Decision             3             2             1             0
Withdrawal by Subject             11             4             3             0
Lost to Follow-up             2             5             1             0
Equipment/Device Availability             0             1             0             0
Death             1             1             0             0
Protocol Violation             1             1             1             0
Subject moved out of state             0             1             0             0
Patient unable to be compliant             1             0             0             0
Physician choice to use different device             1             2             4             0
Insurance             0             0             1             1
Arm/Group Title Blazer Open-Irrigated Ablation Catheter Control Blazer Open-Irrigated Ablation Catheter Roll-In Control Roll-In Total
Hide Arm/Group Description

Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system

Blazer Open-Irrigated Ablation Catheter (Boston Scientific)

FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.

FDA Approved Open-Irrigated Ablation Catheter

Blazer Open-Irrigated Ablation Catheter Roll-In Subjects (Not randomized)

Non-Randomized Subjects treated with an FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.

FDA Approved Open-Irrigated Ablation Catheter

Total of all reporting groups
Overall Number of Baseline Participants 167 172 56 3 398
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 167 participants 172 participants 56 participants 3 participants 398 participants
60  (11) 59  (10) 62  (10) 61  (10) 60  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants 172 participants 56 participants 3 participants 398 participants
Female
62
  37.1%
65
  37.8%
15
  26.8%
1
  33.3%
143
  35.9%
Male
105
  62.9%
107
  62.2%
41
  73.2%
2
  66.7%
255
  64.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants 172 participants 56 participants 3 participants 398 participants
Sweden
0
   0.0%
1
   0.6%
0
   0.0%
0
   0.0%
1
   0.3%
United States
107
  64.1%
112
  65.1%
46
  82.1%
2
  66.7%
267
  67.1%
United Kingdom
3
   1.8%
3
   1.7%
1
   1.8%
0
   0.0%
7
   1.8%
Australia
6
   3.6%
5
   2.9%
2
   3.6%
0
   0.0%
13
   3.3%
France
3
   1.8%
3
   1.7%
0
   0.0%
0
   0.0%
6
   1.5%
Portugal
3
   1.8%
2
   1.2%
3
   5.4%
1
  33.3%
9
   2.3%
Germany
18
  10.8%
18
  10.5%
0
   0.0%
0
   0.0%
36
   9.0%
Spain
27
  16.2%
28
  16.3%
4
   7.1%
0
   0.0%
59
  14.8%
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 167 participants 172 participants 56 participants 3 participants 398 participants
173  (9) 174  (9) 175  (11) 175  (11) 174  (10)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 167 participants 172 participants 56 participants 3 participants 398 participants
89  (19) 90  (22) 94  (21) 79  (15) 90  (21)
Resting Heart Rate  
Mean (Standard Deviation)
Unit of measure:  Bpm
Number Analyzed 167 participants 172 participants 56 participants 3 participants 398 participants
71  (19) 67  (15) 68  (17) 68  (7) 69  (17)
New York Heart Assessment (NYHA) Class   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants 172 participants 56 participants 3 participants 398 participants
I
67
  40.1%
64
  37.2%
20
  35.7%
3
 100.0%
154
  38.7%
II
17
  10.2%
13
   7.6%
10
  17.9%
0
   0.0%
40
  10.1%
Non Heart Failure (HF)
76
  45.5%
92
  53.5%
24
  42.9%
0
   0.0%
192
  48.2%
Not Assessed
7
   4.2%
3
   1.7%
2
   3.6%
0
   0.0%
12
   3.0%
[1]
Measure Description:

NYHA Class at enrollment based upon the following definitions:

Class I - Subjects with heart disease who are able to remain at a comfortable state while performing ordinary physical activity Class II - Subjects who are comfortable at rest or with mild exertion but experience symptoms with more strenuous activity Class III - Subjects who are comfortable at rest but experience symptoms with mild activity Class IV - Subjects who are symptomatic at rest and are unable to carry out any physical activity

1.Primary Outcome
Title Procedure-related Complication Free Rate
Hide Description

The safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group serious adverse event rate is non-inferior to that of the control group.

The safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group rate of significant pulmonary vein stenosis (≥70% reduction in diameter from baseline) and atrio-esophageal fistulas is non-inferior to that of the control group.

Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome Measures were not assessed for the non-randomized participants.
Arm/Group Title Blazer Open-Irrigated Ablation Catheter Control
Hide Arm/Group Description:

Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system

Blazer Open-Irrigated Ablation Catheter (Boston Scientific)

FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.

FDA Approved Open-Irrigated Ablation Catheter

Overall Number of Participants Analyzed 157 164
Measure Type: Count of Participants
Unit of Measure: Participants
140
  89.2%
148
  90.2%
2.Primary Outcome
Title Chronic Success Rate
Hide Description

The primary effectiveness of the Blazer OI catheter will be evaluated by demonstrating that the proportion of subjects free from failure* in the investigational group is non-inferior to those in the control group.

*failure is defined as a randomized subject being an acute procedural failure, having more than one repeat procedure during the 90 day blanking period or having a documented symptomatic atrial fibrillation, atrial tachycardia, atrial fibrillation between 91 days and 12 months post-procedure.

Time Frame Within 12 months of the index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome Measures were not assessed for the non-randomized participants.
Arm/Group Title Blazer Open-Irrigated Ablation Catheter Control
Hide Arm/Group Description:

Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system

Blazer Open-Irrigated Ablation Catheter (Boston Scientific)

FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.

FDA Approved Open-Irrigated Ablation Catheter

Overall Number of Participants Analyzed 157 164
Measure Type: Count of Participants
Unit of Measure: Participants
102
  65.0%
108
  65.9%
3.Secondary Outcome
Title Acute Success
Hide Description Demonstration that the investigational group acute procedural success rate is non-inferior to that of the control group. Acute procedural success is defined as a subject that successfully had all clinically relevant veins electrically isolated, by demonstration of entrance block at a minimum and no evidence of exit conduction with the randomized investigational or control catheter only.
Time Frame Acute- During Index Procedure, 20 minutes after confirmation of Pulmonary Vein Isolation
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome Measures were not assessed for the non-randomized participants.
Arm/Group Title Blazer Open-Irrigated Ablation Catheter Control
Hide Arm/Group Description:

Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system

Blazer Open-Irrigated Ablation Catheter (Boston Scientific)

FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.

FDA Approved Open-Irrigated Ablation Catheter

Overall Number of Participants Analyzed 157 164
Measure Type: Count of Participants
Unit of Measure: Participants
155
  98.7%
163
  99.4%
Time Frame Adverse events were collected from enrollment to end of follow-up ~12Months.
Adverse Event Reporting Description Adverse event data is reported for treatment and attempt subjects.
 
Arm/Group Title Blazer Open-Irrigated Ablation Catheter Randomized FDA Approved Open-Irrigated Ablation Catheter Randomized Blazer Open-Irrigated Ablation Catheter Roll-In FDA Approved Open-Irrigated Ablation Catheter Roll-In
Hide Arm/Group Description

Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system

Blazer Open-Irrigated Ablation Catheter (Boston Scientific)

FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.

FDA Approved Open-Irrigated Ablation Catheter

Roll-In Cases for Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system

Blazer Open-Irrigated Ablation Catheter (Boston Scientific)

Roll-In Cases for FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.

FDA Approved Open-Irrigated Ablation Catheter

All-Cause Mortality
Blazer Open-Irrigated Ablation Catheter Randomized FDA Approved Open-Irrigated Ablation Catheter Randomized Blazer Open-Irrigated Ablation Catheter Roll-In FDA Approved Open-Irrigated Ablation Catheter Roll-In
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/159 (0.63%)      1/167 (0.60%)      0/51 (0.00%)      0/1 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Blazer Open-Irrigated Ablation Catheter Randomized FDA Approved Open-Irrigated Ablation Catheter Randomized Blazer Open-Irrigated Ablation Catheter Roll-In FDA Approved Open-Irrigated Ablation Catheter Roll-In
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   66/159 (41.51%)      65/167 (38.92%)      19/51 (37.25%)      0/1 (0.00%)    
Cardiac disorders         
Arrhythmia (Ablation Procedure)   3/159 (1.89%)  3 2/167 (1.20%)  2 1/51 (1.96%)  1 0/1 (0.00%)  0
Atrial fibrillation (AF)   18/159 (11.32%)  18 27/167 (16.17%)  28 6/51 (11.76%)  6 0/1 (0.00%)  0
Atrial flutter (type 1 Isthmus Dependent)   3/159 (1.89%)  3 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Atrial tachycardia   2/159 (1.26%)  4 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Atypical Atrial Flutter   5/159 (3.14%)  6 2/167 (1.20%)  2 1/51 (1.96%)  1 0/1 (0.00%)  0
Atypical atrial flutter   1/159 (0.63%)  1 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Cardiac arrest   2/159 (1.26%)  2 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Cardiac tamponade/perforation   4/159 (2.52%)  4 3/167 (1.80%)  3 0/51 (0.00%)  0 0/1 (0.00%)  0
Cardiomyopathy   1/159 (0.63%)  1 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Cerebrovascular accident (CVA)   1/159 (0.63%)  1 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Chest pain - Heart failure   0/159 (0.00%)  0 0/167 (0.00%)  0 1/51 (1.96%)  1 0/1 (0.00%)  0
Coronary Artery Disease   1/159 (0.63%)  1 2/167 (1.20%)  2 0/51 (0.00%)  0 0/1 (0.00%)  0
Heart failure   1/159 (0.63%)  1 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Heart failure symptoms - Unspecified   1/159 (0.63%)  1 0/167 (0.00%)  0 1/51 (1.96%)  2 0/1 (0.00%)  0
Hypertension   0/159 (0.00%)  0 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Hypotension   1/159 (0.63%)  1 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Multiple heart failure symptoms   1/159 (0.63%)  1 0/167 (0.00%)  0 1/51 (1.96%)  2 0/1 (0.00%)  0
Myocardial infarction   2/159 (1.26%)  2 0/167 (0.00%)  0 1/51 (1.96%)  1 0/1 (0.00%)  0
Other SVT (AVRT, AVNRT, EAT etc.   0/159 (0.00%)  0 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Palpitations   0/159 (0.00%)  0 1/167 (0.60%)  1 1/51 (1.96%)  1 0/1 (0.00%)  0
Pericardial Effusion (Ablation Procedure)   2/159 (1.26%)  2 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Pericarditis (Ablation Procedure)   1/159 (0.63%)  1 0/167 (0.00%)  0 2/51 (3.92%)  2 0/1 (0.00%)  0
Premature atrial contractions (PAC)   1/159 (0.63%)  1 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Pulmonary Vein Stenosis - Significant (>70%)   1/159 (0.63%)  1 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Pulmonary edema - Heart failure   1/159 (0.63%)  1 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Pulmonary embolism (PE)   1/159 (0.63%)  1 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Sinus bradycardia   1/159 (0.63%)  1 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Syncope   1/159 (0.63%)  1 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Endocrine disorders         
Endocrine   0/159 (0.00%)  0 1/167 (0.60%)  1 1/51 (1.96%)  1 0/1 (0.00%)  0
Gastrointestinal disorders         
Gastrointestinal   5/159 (3.14%)  5 4/167 (2.40%)  4 2/51 (3.92%)  3 0/1 (0.00%)  0
General disorders         
Adverse medication reaction   0/159 (0.00%)  0 0/167 (0.00%)  0 2/51 (3.92%)  2 0/1 (0.00%)  0
Alcohol dependency   1/159 (0.63%)  1 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Cancer   1/159 (0.63%)  1 3/167 (1.80%)  3 0/51 (0.00%)  0 0/1 (0.00%)  0
Chest pain   3/159 (1.89%)  3 2/167 (1.20%)  2 1/51 (1.96%)  1 0/1 (0.00%)  0
Dizziness   5/159 (3.14%)  5 2/167 (1.20%)  2 0/51 (0.00%)  0 0/1 (0.00%)  0
Fluid volume overload( i.e. diuresis, electrolyte imbalance) (Ablation Procedure)   2/159 (1.26%)  2 0/167 (0.00%)  0 1/51 (1.96%)  1 0/1 (0.00%)  0
Head, eyes, ears, nose, throat (HEENT)   3/159 (1.89%)  3 2/167 (1.20%)  2 3/51 (5.88%)  4 0/1 (0.00%)  0
Hiccups   0/159 (0.00%)  0 0/167 (0.00%)  0 1/51 (1.96%)  1 0/1 (0.00%)  0
IV infiltrate   0/159 (0.00%)  0 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Multiple symptoms   1/159 (0.63%)  2 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Infections and infestations         
Sanguineous drainage   0/159 (0.00%)  0 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Systemic infection   0/159 (0.00%)  0 2/167 (1.20%)  2 0/51 (0.00%)  0 0/1 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Musculoskeletal   9/159 (5.66%)  9 3/167 (1.80%)  3 2/51 (3.92%)  2 0/1 (0.00%)  0
Psychiatric disorders         
Psychological   0/159 (0.00%)  0 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Renal and urinary disorders         
Genitourinary   8/159 (5.03%)  9 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Renal   1/159 (0.63%)  1 0/167 (0.00%)  0 2/51 (3.92%)  2 0/1 (0.00%)  0
Renal insufficiency - Heart failure   0/159 (0.00%)  0 0/167 (0.00%)  0 1/51 (1.96%)  1 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Dyspnea   0/159 (0.00%)  0 1/167 (0.60%)  1 1/51 (1.96%)  1 0/1 (0.00%)  0
Pulmonary   11/159 (6.92%)  12 7/167 (4.19%)  8 1/51 (1.96%)  1 0/1 (0.00%)  0
Vascular disorders         
AV Fistula   1/159 (0.63%)  1 1/167 (0.60%)  1 1/51 (1.96%)  1 0/1 (0.00%)  0
Hematoma (Ablation Procedure)   2/159 (1.26%)  2 1/167 (0.60%)  1 1/51 (1.96%)  1 0/1 (0.00%)  0
Rectus sheath hematoma   1/159 (0.63%)  1 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Blazer Open-Irrigated Ablation Catheter Randomized FDA Approved Open-Irrigated Ablation Catheter Randomized Blazer Open-Irrigated Ablation Catheter Roll-In FDA Approved Open-Irrigated Ablation Catheter Roll-In
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   104/159 (65.41%)      95/167 (56.89%)      33/51 (64.71%)      0/1 (0.00%)    
Blood and lymphatic system disorders         
Hematological   1/159 (0.63%)  1 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Cardiac disorders         
1st degree AV block   7/159 (4.40%)  7 5/167 (2.99%)  5 0/51 (0.00%)  0 0/1 (0.00%)  0
2nd degree AV block   0/159 (0.00%)  0 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Angina   1/159 (0.63%)  1 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Aortic root atheromatosis   0/159 (0.00%)  0 0/167 (0.00%)  0 1/51 (1.96%)  1 0/1 (0.00%)  0
Arrhythmia (Ablation Procedure)   1/159 (0.63%)  1 0/167 (0.00%)  0 1/51 (1.96%)  1 0/1 (0.00%)  0
Arterial/Venous Thromboembolic Events   1/159 (0.63%)  1 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Atrial fibrillation (AF)   22/159 (13.84%)  22 32/167 (19.16%)  33 12/51 (23.53%)  12 0/1 (0.00%)  0
Atrial flutter (type 1 Isthmus Dependent)   3/159 (1.89%)  3 2/167 (1.20%)  2 2/51 (3.92%)  2 0/1 (0.00%)  0
Atrial tachycardia   11/159 (6.92%)  11 6/167 (3.59%)  6 0/51 (0.00%)  0 0/1 (0.00%)  0
Atypical Atrial Flutter   3/159 (1.89%)  3 3/167 (1.80%)  3 0/51 (0.00%)  0 0/1 (0.00%)  0
Bradycardia with pauses   0/159 (0.00%)  0 0/167 (0.00%)  0 1/51 (1.96%)  1 0/1 (0.00%)  0
Breathing difficulties   0/159 (0.00%)  0 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Brugada syndrome   1/159 (0.63%)  1 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Chest pain   12/159 (7.55%)  13 6/167 (3.59%)  9 3/51 (5.88%)  3 0/1 (0.00%)  0
Chest pain – Ischemic   0/159 (0.00%)  0 0/167 (0.00%)  0 1/51 (1.96%)  1 0/1 (0.00%)  0
Cyst on ascending aorta   1/159 (0.63%)  1 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Heart failure symptoms - Unspecified   0/159 (0.00%)  0 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Hypertension   5/159 (3.14%)  6 3/167 (1.80%)  3 1/51 (1.96%)  1 0/1 (0.00%)  0
Hypotension   1/159 (0.63%)  1 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Hypotension (Ablation Procedure)   0/159 (0.00%)  0 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Intracardiac thrombus with no thromboembolic event   2/159 (1.26%)  2 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Intraventricular conduction delay   0/159 (0.00%)  0 0/167 (0.00%)  0 1/51 (1.96%)  1 0/1 (0.00%)  0
Junctional ectopic rhythm   1/159 (0.63%)  1 0/167 (0.00%)  0 1/51 (1.96%)  1 0/1 (0.00%)  0
Long QT   0/159 (0.00%)  0 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Multiple heart failure symptoms   1/159 (0.63%)  1 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Nonsustained ventricular tachycardia (NSVT)   1/159 (0.63%)  1 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Other SVT (AVRT, AVNRT, EAT etc.   1/159 (0.63%)  1 1/167 (0.60%)  1 3/51 (5.88%)  3 0/1 (0.00%)  0
Palpitations   4/159 (2.52%)  4 6/167 (3.59%)  7 2/51 (3.92%)  2 0/1 (0.00%)  0
Pericardial Effusion (Ablation Procedure)   3/159 (1.89%)  3 3/167 (1.80%)  3 1/51 (1.96%)  1 0/1 (0.00%)  0
Pericardial effusion   1/159 (0.63%)  1 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Pericardial effusion - Unrelated to procedure   2/159 (1.26%)  2 0/167 (0.00%)  0 1/51 (1.96%)  1 0/1 (0.00%)  0
Pleuritis (Ablation Procedure)   0/159 (0.00%)  0 1/167 (0.60%)  1 2/51 (3.92%)  2 0/1 (0.00%)  0
Premature atrial contractions (PAC)   5/159 (3.14%)  5 2/167 (1.20%)  2 1/51 (1.96%)  1 0/1 (0.00%)  0
Premature ventricular contractions (PVC)   1/159 (0.63%)  1 3/167 (1.80%)  3 1/51 (1.96%)  1 0/1 (0.00%)  0
Pulmonary Vein Stenosis - Mild or Moderate (<70%)   4/159 (2.52%)  4 0/167 (0.00%)  0 2/51 (3.92%)  2 0/1 (0.00%)  0
Pulmonary Vein Stenosis - Significant (>70%)   0/159 (0.00%)  0 2/167 (1.20%)  2 0/51 (0.00%)  0 0/1 (0.00%)  0
Right bundle branch block   1/159 (0.63%)  1 0/167 (0.00%)  0 1/51 (1.96%)  1 0/1 (0.00%)  0
Sinus arrhythmia   0/159 (0.00%)  0 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Sinus bradycardia   5/159 (3.14%)  5 6/167 (3.59%)  6 2/51 (3.92%)  2 0/1 (0.00%)  0
Sinus tachycardia   8/159 (5.03%)  8 4/167 (2.40%)  4 0/51 (0.00%)  0 0/1 (0.00%)  0
Syncope   2/159 (1.26%)  2 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Tachycardia (Ablation Procedure)   1/159 (0.63%)  1 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Thrombus (No embolism) (Ablation Procedure)   0/159 (0.00%)  0 0/167 (0.00%)  0 1/51 (1.96%)  1 0/1 (0.00%)  0
Typical atrial flutter   1/159 (0.63%)  1 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Ventricular tachycardia (VT)   1/159 (0.63%)  1 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Endocrine disorders         
Endocrine   2/159 (1.26%)  2 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Eye disorders         
Visual Blurring/Disturbances (Ablation Procedure)   1/159 (0.63%)  1 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Gastrointestinal disorders         
Cirrhosis   0/159 (0.00%)  0 0/167 (0.00%)  0 1/51 (1.96%)  1 0/1 (0.00%)  0
Gastrointestinal   9/159 (5.66%)  10 9/167 (5.39%)  12 3/51 (5.88%)  3 0/1 (0.00%)  0
Gastroparesis (Ablation Procedure)   1/159 (0.63%)  1 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Increased GERD   0/159 (0.00%)  0 0/167 (0.00%)  0 1/51 (1.96%)  1 0/1 (0.00%)  0
General disorders         
Abnormal laboratory values   6/159 (3.77%)  6 1/167 (0.60%)  1 2/51 (3.92%)  2 0/1 (0.00%)  0
Adverse medication reaction   9/159 (5.66%)  11 8/167 (4.79%)  8 3/51 (5.88%)  3 0/1 (0.00%)  0
Allergic reaction   1/159 (0.63%)  1 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Allergic reaction (Ablation Procedure)   1/159 (0.63%)  1 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Anesthesia/Sedation related complication (Ablation Procedure)   1/159 (0.63%)  3 0/167 (0.00%)  0 1/51 (1.96%)  1 0/1 (0.00%)  0
Cancer   0/159 (0.00%)  0 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Dehydration   1/159 (0.63%)  1 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Difficulty sleeping   0/159 (0.00%)  0 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Dizziness   2/159 (1.26%)  2 7/167 (4.19%)  7 2/51 (3.92%)  2 0/1 (0.00%)  0
Epistaxis   1/159 (0.63%)  1 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Exacerbation of existing condition (Ablation Procedure)   0/159 (0.00%)  0 0/167 (0.00%)  0 1/51 (1.96%)  1 0/1 (0.00%)  0
Fatigue   1/159 (0.63%)  1 0/167 (0.00%)  0 1/51 (1.96%)  1 0/1 (0.00%)  0
Fever   1/159 (0.63%)  1 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Fluid retention   0/159 (0.00%)  0 1/167 (0.60%)  1 1/51 (1.96%)  1 0/1 (0.00%)  0
Groin pain   1/159 (0.63%)  1 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Head, eyes, ears, nose, throat (HEENT)   13/159 (8.18%)  13 12/167 (7.19%)  14 3/51 (5.88%)  3 0/1 (0.00%)  0
Hemorrhage (Ablation Procedure)   2/159 (1.26%)  2 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Integumentary   5/159 (3.14%)  5 3/167 (1.80%)  3 1/51 (1.96%)  1 0/1 (0.00%)  0
Physical trauma   3/159 (1.89%)  3 2/167 (1.20%)  2 1/51 (1.96%)  1 0/1 (0.00%)  0
Sore throat   0/159 (0.00%)  0 3/167 (1.80%)  3 1/51 (1.96%)  1 0/1 (0.00%)  0
Infections and infestations         
Lyme disease   1/159 (0.63%)  1 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Non-toxic LLE cellulitis   0/159 (0.00%)  0 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Back discomfort   0/159 (0.00%)  0 1/167 (0.60%)  1 1/51 (1.96%)  1 0/1 (0.00%)  0
Musculoskeletal   7/159 (4.40%)  7 8/167 (4.79%)  8 2/51 (3.92%)  2 0/1 (0.00%)  0
Nervous system disorders         
Neurological   1/159 (0.63%)  1 5/167 (2.99%)  5 1/51 (1.96%)  1 0/1 (0.00%)  0
Pain neuromuscular/non cardiovascular (Ablation Procedure)   2/159 (1.26%)  2 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Peripheral neuropathy   0/159 (0.00%)  0 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Psychiatric disorders         
Depression   0/159 (0.00%)  0 0/167 (0.00%)  0 1/51 (1.96%)  1 0/1 (0.00%)  0
Psychological   2/159 (1.26%)  2 2/167 (1.20%)  2 0/51 (0.00%)  0 0/1 (0.00%)  0
Renal and urinary disorders         
Genitourinary   10/159 (6.29%)  10 10/167 (5.99%)  10 4/51 (7.84%)  4 0/1 (0.00%)  0
Renal   1/159 (0.63%)  1 0/167 (0.00%)  0 1/51 (1.96%)  1 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Dyspnea   8/159 (5.03%)  8 1/167 (0.60%)  1 1/51 (1.96%)  1 0/1 (0.00%)  0
Dyspnea on exertion   1/159 (0.63%)  1 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Pulmonary   11/159 (6.92%)  14 9/167 (5.39%)  9 1/51 (1.96%)  2 0/1 (0.00%)  0
Vagal denervation symptoms   0/159 (0.00%)  0 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Vascular disorders         
AV Fistula   0/159 (0.00%)  0 0/167 (0.00%)  0 1/51 (1.96%)  1 0/1 (0.00%)  0
Edema (Ablation Procedure)   2/159 (1.26%)  2 0/167 (0.00%)  0 1/51 (1.96%)  1 0/1 (0.00%)  0
Groin bleed (Ablation Procedure)   0/159 (0.00%)  0 0/167 (0.00%)  0 1/51 (1.96%)  1 0/1 (0.00%)  0
Hematoma (Ablation Procedure)   7/159 (4.40%)  7 4/167 (2.40%)  4 4/51 (7.84%)  4 0/1 (0.00%)  0
Peripheral edema   3/159 (1.89%)  3 0/167 (0.00%)  0 1/51 (1.96%)  1 0/1 (0.00%)  0
Peripheral edema - Heart failure   0/159 (0.00%)  0 1/167 (0.60%)  1 0/51 (0.00%)  0 0/1 (0.00%)  0
Pseudoaneurysm   0/159 (0.00%)  0 0/167 (0.00%)  0 1/51 (1.96%)  1 0/1 (0.00%)  0
Swollen groin   2/159 (1.26%)  2 0/167 (0.00%)  0 0/51 (0.00%)  0 0/1 (0.00%)  0
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Manager
Organization: Boston Scientific
Phone: 617-218-3849
EMail: weismanm@bsci.com
Layout table for additonal information
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01687166     History of Changes
Other Study ID Numbers: CDM00048665
First Submitted: August 29, 2012
First Posted: September 18, 2012
Results First Submitted: February 15, 2018
Results First Posted: June 18, 2018
Last Update Posted: November 21, 2018