Trial Outcomes & Findings for Prospective Evaluation of Open Irrigated Ablation Catheters With High Resolution Mapping to Treat Paroxysmal Atrial Fibrillation (NCT NCT03729830)
NCT ID: NCT03729830
Last Updated: 2026-01-21
Results Overview
This measure reports the observed safety event -free rate at 12 Months follow up. The safety events are a composite of acute primary safety events (events occurring within seven days post-procedure or hospital discharge, whichever is later), and chronic primary safety events (events occurring through 3- or 12-months post-procedure, as listed below). Acute primary safety endpoint events are defined as the following: * Death * Myocardial infarction (MI) * Vagal Nerve Injury/Gastroparesis * Transient ischemic attack (TIA) * Stroke/Cerebrovascular accident (CVA) * Thromboembolism * Pericarditis * Cardiac tamponade/perforation * Pneumothorax * Vascular access complications * Pulmonary edema/heart failure * AV block Chronic primary safety endpoint events are defined as the following occurring through: 3 Months post-procedure 12 Months post-procedure * Atrial esophageal fistula * Pericardial effusion * Pulmonary vein stenosis (symptomatic and requiring intervention)
Recruitment status
COMPLETED
Target enrollment
415 participants
Primary outcome timeframe
12 months
Results posted on
2026-01-21
Participant Flow
Participant milestones
| Measure |
INTERRUPT AF Clinical Study
Patients who underwent treatment with a Boston Scientific open-irrigated ablation catheter for the treatment of paroxysmal atrial fibrillation in conjunction with the Rhymthia Mapping System
Devices/Systems used in the study:
Boston Scientific Open-Irrigated Catheters:
* IntellaNav Open-Irrigated Ablation Catheter
* IntellaNav MiFi Open-Irrigated Ablation Catheter
* IntellaTip MiFi Open-Irrigated Ablation Catheter
* Rhythmia Mapping System Gen 1or Rhythmia HDx, equipped with Software 1.4 or any successive commercially approved versions.
* IntellaMap Orion Catheter
|
|---|---|
|
Overall Study
STARTED
|
415
|
|
Overall Study
Procedure
|
383
|
|
Overall Study
COMPLETED
|
148
|
|
Overall Study
NOT COMPLETED
|
267
|
Reasons for withdrawal
| Measure |
INTERRUPT AF Clinical Study
Patients who underwent treatment with a Boston Scientific open-irrigated ablation catheter for the treatment of paroxysmal atrial fibrillation in conjunction with the Rhymthia Mapping System
Devices/Systems used in the study:
Boston Scientific Open-Irrigated Catheters:
* IntellaNav Open-Irrigated Ablation Catheter
* IntellaNav MiFi Open-Irrigated Ablation Catheter
* IntellaTip MiFi Open-Irrigated Ablation Catheter
* Rhythmia Mapping System Gen 1or Rhythmia HDx, equipped with Software 1.4 or any successive commercially approved versions.
* IntellaMap Orion Catheter
|
|---|---|
|
Overall Study
Active at study close
|
136
|
|
Overall Study
Subject withdrew consent
|
40
|
|
Overall Study
Intent
|
32
|
|
Overall Study
Lost to Follow-up
|
31
|
|
Overall Study
research facility closed down
|
9
|
|
Overall Study
Death
|
5
|
|
Overall Study
Physician Decision
|
4
|
|
Overall Study
No longer meets protocol criteria
|
3
|
|
Overall Study
Protocol Violation
|
6
|
|
Overall Study
Sponsor withdrew subject
|
1
|
Baseline Characteristics
414 analyzed instead of 415 as 1 patient withdrew from the study prior to providing this information
Baseline characteristics by cohort
| Measure |
INTERRUPT AF Clinical Study
n=415 Participants
Patients who underwent treatment with a Boston Scientific open-irrigated ablation catheter for the treatment of paroxysmal atrial fibrillation in conjunction with the Rhymthia Mapping System
Devices/Systems used in the study:
Boston Scientific Open-Irrigated Catheters:
* IntellaNav Open-Irrigated Ablation Catheter
* IntellaNav MiFi Open-Irrigated Ablation Catheter
* IntellaTip MiFi Open-Irrigated Ablation Catheter
* Rhythmia Mapping System Gen 1or Rhythmia HDx, equipped with Software 1.4 or any successive commercially approved versions.
* IntellaMap Orion Catheter
|
|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 10.4 • n=414 Participants • 414 analyzed instead of 415 as 1 patient withdrew from the study prior to providing this information
|
|
Sex: Female, Male
Female
|
155 Participants
n=414 Participants • 414 analyzed instead of 415 as 1 patient withdrew from the study prior to providing this information
|
|
Sex: Female, Male
Male
|
259 Participants
n=414 Participants • 414 analyzed instead of 415 as 1 patient withdrew from the study prior to providing this information
|
|
Race/Ethnicity, Customized
Race · White
|
282 Participants
n=407 Participants • Race not reported for 8 subjects
|
|
Race/Ethnicity, Customized
Race · Black
|
10 Participants
n=407 Participants • Race not reported for 8 subjects
|
|
Race/Ethnicity, Customized
Race · Hispanic or Latino
|
5 Participants
n=407 Participants • Race not reported for 8 subjects
|
|
Race/Ethnicity, Customized
Race · Asian
|
95 Participants
n=407 Participants • Race not reported for 8 subjects
|
|
Race/Ethnicity, Customized
Race · Race Not Disclosed
|
15 Participants
n=407 Participants • Race not reported for 8 subjects
|
|
Region of Enrollment
South Korea
|
21 participants
n=415 Participants
|
|
Region of Enrollment
Monaco
|
6 participants
n=415 Participants
|
|
Region of Enrollment
United States
|
278 participants
n=415 Participants
|
|
Region of Enrollment
Japan
|
82 participants
n=415 Participants
|
|
Region of Enrollment
United Kingdom
|
4 participants
n=415 Participants
|
|
Region of Enrollment
Germany
|
24 participants
n=415 Participants
|
|
Weight
|
87.7 kg
STANDARD_DEVIATION 24.2 • n=413 Participants • Weight not reported for 2 subjects
|
|
Height
|
172.1 cm
STANDARD_DEVIATION 10.2 • n=413 Participants • Height not reported for 2subjects
|
|
BMI
|
29.4 kg/m^2
STANDARD_DEVIATION 7.2 • n=413 Participants • BMI not reported for 2 subjects
|
|
Resting Systolic BP
|
132.6 mmHG
STANDARD_DEVIATION 19.6 • n=412 Participants • Resting systolic BP not reported for 3 subjects
|
|
Resting Diastolic BP
|
78.4 mmHG
STANDARD_DEVIATION 12.6 • n=412 Participants • Resting diastolic BP not reported for 3 subjects
|
|
Resting Heart Rate
|
68.4 bpm
STANDARD_DEVIATION 15.1 • n=412 Participants • Resting heart rate not reported for 3 subjects
|
|
Cardiac Non-Arrhythmic
Cardiovascular Disease
|
227 Participants
n=415 Participants
|
|
Cardiac Non-Arrhythmic
Cardiomyopathy
|
34 Participants
n=415 Participants
|
|
Cardiac Non-Arrhythmic
Valvular Disease
|
21 Participants
n=415 Participants
|
|
Cardiac Non-Arrhythmic
Coronary Artery Disease
|
74 Participants
n=415 Participants
|
|
Cardiac Non-Arrhythmic
Cardiac Disease Other
|
15 Participants
n=415 Participants
|
|
Cardiac Non-Arrhythmic
Congestive Heart Failure
|
25 Participants
n=415 Participants
|
|
Cardiac Non-Arrhythmic
Cerebrovascular Disease
|
4 Participants
n=415 Participants
|
|
Cardiac Non-Arrhythmic
Peripheral Vascular Disease
|
12 Participants
n=415 Participants
|
|
Cardiac Non-Arrhythmic
Hypertension
|
159 Participants
n=415 Participants
|
|
Cardiac Non-Arrhythmic
Pulmonary Hypertension
|
5 Participants
n=415 Participants
|
|
Cardiac Non-Arrhythmic
Hyperlipidemia
|
119 Participants
n=415 Participants
|
|
Cardiac Non-Arrhythmic
Coagulopathy - Hypercoagulable State - Clotting Disorder
|
11 Participants
n=415 Participants
|
|
Cardiac Non-Arrhythmic
Transient Ischemic Attack (TIA) CVA or PE
|
19 Participants
n=415 Participants
|
|
Cardiac Non-Arrhythmic
Cardiac thrombus
|
5 Participants
n=415 Participants
|
|
Cardiac Non-Arrhythmic
Other cardiovascular disease occurred
|
194 Participants
n=415 Participants
|
|
Cardiac Non-Arrhythmic
No history of cardiac disease
|
186 Participants
n=415 Participants
|
|
Cardiac Procedure History
Cardiac procedures
|
77 Participants
n=414 Participants • 414 analyzed instead of 415 as 1 patient withdrew from the study prior to providing this information
|
|
Cardiac Procedure History
Cardiac ablations
|
28 Participants
n=414 Participants • 414 analyzed instead of 415 as 1 patient withdrew from the study prior to providing this information
|
|
Cardiac Procedure History
None
|
309 Participants
n=414 Participants • 414 analyzed instead of 415 as 1 patient withdrew from the study prior to providing this information
|
|
Noncardiac Comorbidities
COPD
|
24 Participants
n=415 Participants
|
|
Noncardiac Comorbidities
Diabetes
|
60 Participants
n=415 Participants
|
|
Noncardiac Comorbidities
Hepatic Disease
|
7 Participants
n=415 Participants
|
|
Noncardiac Comorbidities
Neurological Disease
|
11 Participants
n=415 Participants
|
|
Noncardiac Comorbidities
Renal Disease
|
17 Participants
n=415 Participants
|
|
Noncardiac Comorbidities
GI Bleeding
|
12 Participants
n=415 Participants
|
|
Noncardiac Comorbidities
Sleep Disordered Breathing
|
76 Participants
n=415 Participants
|
|
Noncardiac Comorbidities
Other comorbidities
|
97 Participants
n=415 Participants
|
|
Noncardiac Comorbidities
Non-study hospitalization
|
16 Participants
n=415 Participants
|
|
Noncardiac Comorbidities
None
|
211 Participants
n=415 Participants
|
|
Arrhythmia History
Ventricular Arrhythmia Occurred
|
56 Participants
n=412 Participants • Arrhythmia history not reported for 3 patients
|
|
Arrhythmia History
No Ventricular Arrhythmias
|
357 Participants
n=412 Participants • Arrhythmia history not reported for 3 patients
|
|
Arrhythmia History
Atrial Arrhythmia Occurred
|
412 Participants
n=412 Participants • Arrhythmia history not reported for 3 patients
|
|
Arrhythmia History
No Atrial Arrhythmias
|
1 Participants
n=412 Participants • Arrhythmia history not reported for 3 patients
|
|
Arrhythmia History
ORT or AVRT
|
5 Participants
n=412 Participants • Arrhythmia history not reported for 3 patients
|
|
Arrhythmia History
Focal Atrial Tachycardia
|
2 Participants
n=412 Participants • Arrhythmia history not reported for 3 patients
|
|
Arrhythmia History
Accessory Pathway
|
9 Participants
n=412 Participants • Arrhythmia history not reported for 3 patients
|
|
Arrhythmia History
Paroxysmal Atrial Fibrillation
|
412 Participants
n=412 Participants • Arrhythmia history not reported for 3 patients
|
|
Arrhythmia History
Atrial Tachycardia
|
25 Participants
n=412 Participants • Arrhythmia history not reported for 3 patients
|
|
Arrhythmia History
Atrial Flutter
|
103 Participants
n=412 Participants • Arrhythmia history not reported for 3 patients
|
|
Arrhythmia History
Atrial Arrhythmia Other
|
16 Participants
n=412 Participants • Arrhythmia history not reported for 3 patients
|
|
Arrhythmia History
Brady Arrhythmia Occurred
|
108 Participants
n=412 Participants • Arrhythmia history not reported for 3 patients
|
|
Arrhythmia History
Sinus Bradycardia
|
92 Participants
n=412 Participants • Arrhythmia history not reported for 3 patients
|
|
Arrhythmia History
Sinus Node Dysfunction
|
11 Participants
n=412 Participants • Arrhythmia history not reported for 3 patients
|
|
Arrhythmia History
Sick Sinus Syndrome Chronotropic Incompetence
|
10 Participants
n=412 Participants • Arrhythmia history not reported for 3 patients
|
|
Arrhythmia History
Sinus arrest
|
2 Participants
n=412 Participants • Arrhythmia history not reported for 3 patients
|
|
Arrhythmia History
AV Block 1
|
23 Participants
n=412 Participants • Arrhythmia history not reported for 3 patients
|
|
Arrhythmia History
AV Block 2
|
1 Participants
n=412 Participants • Arrhythmia history not reported for 3 patients
|
|
Arrhythmia History
Brady Arrhythmia Other
|
2 Participants
n=412 Participants • Arrhythmia history not reported for 3 patients
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: This analysis includes all treatment and attempt subjects, including those with missing data.
This measure reports the observed safety event -free rate at 12 Months follow up. The safety events are a composite of acute primary safety events (events occurring within seven days post-procedure or hospital discharge, whichever is later), and chronic primary safety events (events occurring through 3- or 12-months post-procedure, as listed below). Acute primary safety endpoint events are defined as the following: * Death * Myocardial infarction (MI) * Vagal Nerve Injury/Gastroparesis * Transient ischemic attack (TIA) * Stroke/Cerebrovascular accident (CVA) * Thromboembolism * Pericarditis * Cardiac tamponade/perforation * Pneumothorax * Vascular access complications * Pulmonary edema/heart failure * AV block Chronic primary safety endpoint events are defined as the following occurring through: 3 Months post-procedure 12 Months post-procedure * Atrial esophageal fistula * Pericardial effusion * Pulmonary vein stenosis (symptomatic and requiring intervention)
Outcome measures
| Measure |
Treatment With Ablation Catheter
n=383 Participants
Patients who undergo treatment with a Boston Scientific open-irrigated ablation catheter for the treatment of paroxysmal atrial fibrillation in conjunction with the Rhymthia Mapping System
Treatment with Blazer Open-Irrigated Ablation Catheter, IntellaNav Open-Irrigated Ablation Catheter, IntellaNav MiFi Open-Irrigated Ablation Catheter, or IntellaTip MiFi Open-Irrigated Ablation Catheter: Patients will be treated with an ablation catheter
|
|---|---|
|
Number of Participants Safety Event-free at 12 Months Post Procedure
|
368 Number of Participants
|
PRIMARY outcome
Timeframe: 12 MonthsThe primary effectiveness endpoint is defined as the event-free rate at 12 months post-procedure. Primary effectiveness events are defined as: * Acute procedural failure * More than one repeat procedure during the blanking period (90 days post index procedure) * Documented atrial fibrillation, or new onset of atrial flutter or atrial tachycardia event (≥ 30 seconds in duration from an event monitor or Holter, or from a 10 second 12-lead EKG) between 91 days and 365 days post index procedure * Any of the following interventions for atrial fibrillation, or new onset of atrial flutter or atrial tachycardia between 91 days and 365 days post index procedure: * Repeat procedure * Cardioversion * Prescribed any AAD\* * AADs for endpoint will consist of all Class I/III and any Class II/IV medications taken for control of AF/AT/AFL recurrence
Outcome measures
| Measure |
Treatment With Ablation Catheter
n=383 Participants
Patients who undergo treatment with a Boston Scientific open-irrigated ablation catheter for the treatment of paroxysmal atrial fibrillation in conjunction with the Rhymthia Mapping System
Treatment with Blazer Open-Irrigated Ablation Catheter, IntellaNav Open-Irrigated Ablation Catheter, IntellaNav MiFi Open-Irrigated Ablation Catheter, or IntellaTip MiFi Open-Irrigated Ablation Catheter: Patients will be treated with an ablation catheter
|
|---|---|
|
Number of Participants Effectiveness Event -Free at 12 Months Post Procedure
|
218 Number of Participants
|
SECONDARY outcome
Timeframe: 12 MonthsThe secondary effectiveness endpoint is defined as the event-free at 12 months post-procedure. Secondary effectiveness events are defined as: * Acute procedural failure * More than one repeat procedure during the blanking period (90 days post index procedure) * Documented symptomatic atrial fibrillation, or new onset of atrial flutter or atrial tachycardia event (≥ 30 seconds in duration from an event monitor or Holter, or from a 10 second 12-lead EKG) between 91 days and 365 days post index procedure * Any of the following interventions for atrial fibrillation, or new onset of atrial flutter or atrial tachycardia between 91 days and 365 days post index procedure: * Repeat procedure * Cardioversion * Prescribed a higher dose of any AAD\* documented at baseline * Prescribed a new AAD\* not documented at baseline * AADs for endpoint will consist of all Class I/III and any Class II/IV medications taken for control of AF/AT/AFL recurrence
Outcome measures
| Measure |
Treatment With Ablation Catheter
n=383 Participants
Patients who undergo treatment with a Boston Scientific open-irrigated ablation catheter for the treatment of paroxysmal atrial fibrillation in conjunction with the Rhymthia Mapping System
Treatment with Blazer Open-Irrigated Ablation Catheter, IntellaNav Open-Irrigated Ablation Catheter, IntellaNav MiFi Open-Irrigated Ablation Catheter, or IntellaTip MiFi Open-Irrigated Ablation Catheter: Patients will be treated with an ablation catheter
|
|---|---|
|
Number of Participants Event Free Rate (Secondary)
|
102 Participants
|
Adverse Events
Treatment With Ablation Catheter
Serious events: 135 serious events
Other events: 46 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Treatment With Ablation Catheter
n=383 participants at risk
Patients who undergo treatment with a Boston Scientific open-irrigated ablation catheter for the treatment of paroxysmal atrial fibrillation in conjunction with the Rhymthia Mapping System
Treatment with Blazer Open-Irrigated Ablation Catheter, IntellaNav Open-Irrigated Ablation Catheter, IntellaNav MiFi Open-Irrigated Ablation Catheter, or IntellaTip MiFi Open-Irrigated Ablation Catheter: Patients will be treated with an ablation catheter
|
|---|---|
|
Surgical and medical procedures
Procedure related general adverse reaction
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Surgical and medical procedures
Angina/Chest pain
|
1.8%
7/383 • Number of events 7 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Blood and lymphatic system disorders
Hematological
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Cardiac disorders
Aortic stenosis
|
0.52%
2/383 • Number of events 2 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Cardiac disorders
Atrial Fibrillation
|
12.0%
46/383 • Number of events 54 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Cardiac disorders
Atrial Flutter
|
3.1%
12/383 • Number of events 13 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Cardiac disorders
Atrial Flutter, not specified
|
0.26%
1/383 • Number of events 2 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Cardiac disorders
Atrial Tachycardia/Other SVT (eg AVRT, AVNRT, EAT)
|
0.78%
3/383 • Number of events 3 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Cardiac disorders
Atrial tachycardia
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Cardiac disorders
Atypical (Type II) Atrial Flutter
|
1.0%
4/383 • Number of events 4 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Cardiac disorders
Cardiac arrest
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Cardiac disorders
Dyspnea - Heart failure
|
0.52%
2/383 • Number of events 2 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Cardiac disorders
Exacerbation of pre-existing condition
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Cardiac disorders
Heart failure symptoms - Unspecified
|
0.78%
3/383 • Number of events 3 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Cardiac disorders
Mitral regurgitation
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Cardiac disorders
Mitral stenosis
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Cardiac disorders
Multiple heart failure symptoms
|
0.78%
3/383 • Number of events 3 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Cardiac disorders
Palpitations
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Cardiac disorders
Peripheral edema - Heart failure
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Cardiac disorders
Premature Ventricular Contractions (PVC)
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Cardiac disorders
Sinus bradycardia
|
0.78%
3/383 • Number of events 3 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Cardiac disorders
Tachy-brady syndrome
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Cardiac disorders
Tachyarrhythmia
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Cardiac disorders
Ventricular Tachycardia (VT)/Monomorphic VT
|
0.52%
2/383 • Number of events 2 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Endocrine disorders
Endocrine
|
0.78%
3/383 • Number of events 3 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Gastrointestinal disorders
Gastrointestinal
|
2.9%
11/383 • Number of events 13 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
General disorders
Abnormal laboratory values
|
1.6%
6/383 • Number of events 6 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
General disorders
Adverse reaction - Medication
|
0.52%
2/383 • Number of events 2 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
General disorders
Chest pain - Other
|
1.6%
6/383 • Number of events 7 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
General disorders
Death
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
General disorders
Dizziness
|
0.52%
2/383 • Number of events 2 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
General disorders
Head, eyes, ears, nose, throat (HEENT)
|
0.78%
3/383 • Number of events 3 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
General disorders
Panniculectomy
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
General disorders
Physical trauma
|
1.8%
7/383 • Number of events 7 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
General disorders
Syncope
|
0.78%
3/383 • Number of events 3 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
General disorders
bleeding from hemodialysis site
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Infections and infestations
Infection - Unrelated (non study) procedure or device
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Infections and infestations
Systemic infection
|
0.52%
2/383 • Number of events 2 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Adverse reaction - Abnormal labs - EP procedure
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Adverse reaction - Anesthesia/Sedation - EP procedure
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Adverse reaction - Hypertension - EP procedure
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Adverse reaction - Hypotension - EP procedure
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Adverse reaction - Neurological (non-TIA, non-stroke) - EP procedure
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Adverse reaction - Pulmonary - EP procedure
|
0.78%
3/383 • Number of events 3 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Conduction pathway injury (pacemaker implantation) - EP procedure
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Exacerbation of existing condition - EP procedure
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Hematoma
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Major bleeding/hemorrhage requiring transfusion
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Myocardial perforation with tamponade
|
0.78%
3/383 • Number of events 3 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Other - Unrelated (non study) procedure or device (ICD EOL)
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Other - Unrelated (non study) procedure or device (LV Lead revision)
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Other - Unrelated (non study) procedure or device (RV Lead revision)
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Pericardial effusion - EP procedure
|
1.6%
6/383 • Number of events 6 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Pericarditis - EP procedure
|
0.52%
2/383 • Number of events 2 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Pleural Effusion - EP procedure
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Post-surgical infection/sepsis - EP procedure
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Pseudoaneurysm - EP procedure
|
0.52%
2/383 • Number of events 2 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Stroke (ischemic) - EP procedure
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Transient Ischemic Attack (TIA) - EP procedure
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
1.6%
6/383 • Number of events 7 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
1.3%
5/383 • Number of events 5 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Nervous system disorders
Neurological
|
1.6%
6/383 • Number of events 6 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Product Issues
Elevated threshold - RA Lead
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Product Issues
Oversensing - RV PG System
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Renal and urinary disorders
Genitourinary
|
1.0%
4/383 • Number of events 4 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Renal and urinary disorders
Renal
|
0.78%
3/383 • Number of events 4 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
2.9%
11/383 • Number of events 17 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Vascular disorders
Adverse reaction - Hypotension
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Vascular disorders
Cerebrovascular Accident (CVA) - unspecifed
|
0.52%
2/383 • Number of events 3 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Vascular disorders
Coronary Artery Disease
|
0.52%
2/383 • Number of events 2 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Vascular disorders
Distal thromboemboli
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Vascular disorders
Edema
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Vascular disorders
Hematoma - Unrelated (non study) procedure or device
|
0.52%
2/383 • Number of events 2 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Vascular disorders
Hypertension/Hypertensive Crisis
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Vascular disorders
Hypotension/Orthostatic Hypotension
|
0.52%
2/383 • Number of events 2 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Vascular disorders
Myocardial infarction
|
1.6%
6/383 • Number of events 6 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Vascular disorders
Pseudoaneurysm with hematoma
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Vascular disorders
Pulmonary Embolism (PE)
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Vascular disorders
Transient Ischemic Attack (TIA)
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
Other adverse events
| Measure |
Treatment With Ablation Catheter
n=383 participants at risk
Patients who undergo treatment with a Boston Scientific open-irrigated ablation catheter for the treatment of paroxysmal atrial fibrillation in conjunction with the Rhymthia Mapping System
Treatment with Blazer Open-Irrigated Ablation Catheter, IntellaNav Open-Irrigated Ablation Catheter, IntellaNav MiFi Open-Irrigated Ablation Catheter, or IntellaTip MiFi Open-Irrigated Ablation Catheter: Patients will be treated with an ablation catheter
|
|---|---|
|
Injury, poisoning and procedural complications
Adverse reaction - General - EP procedure
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Angina/Chest pain - Post EP procedure
|
2.1%
8/383 • Number of events 8 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Puncture site hematoma - EP procedure
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Vasospasm - EP procedure
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Cardiac disorders
Atrial Fibrillation (AF)
|
1.3%
5/383 • Number of events 6 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Cardiac disorders
Atrial Flutter
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Cardiac disorders
Atrial Flutter, not specified
|
0.52%
2/383 • Number of events 2 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Cardiac disorders
Sinus bradycardia
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Gastrointestinal disorders
Gastrointestinal
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
General disorders
Head, eyes, ears, nose, throat (HEENT)
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
General disorders
Syncope
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Adverse reaction - Abnormal labs - EP procedure
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Adverse reaction - Anesthesia/Sedation - EP procedure
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Adverse reaction - Gastrointestinal - EP procedure
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Adverse reaction - Genitourinary/Renal - EP procedure
|
0.52%
2/383 • Number of events 2 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Adverse reaction - Neurological (non-TIA, non-stroke) - EP procedure
|
0.52%
2/383 • Number of events 2 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Angina/Chest pain - EP procedure
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Embolism - Air - EP procedure
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Exacerbation of existing condition - EP procedure
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Hematoma - EP procedure
|
0.52%
2/383 • Number of events 2 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Inadvertent injury to adjacent structure - EP procedure
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Minor oozing/bleeding - EP procedure
|
0.78%
3/383 • Number of events 3 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Pain (non-cardiovascular) - EP procedure
|
1.3%
5/383 • Number of events 5 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Pericarditis - EP procedure
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Post-surgical wound discomfort - EP procedure
|
1.6%
6/383 • Number of events 7 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Stroke (ischemic) - EP procedure
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Injury, poisoning and procedural complications
Ablation-EP Related~Other
|
0.78%
3/383 • Number of events 3 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
0.26%
1/383 • Number of events 1 • 12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415 * Treated = 383 * Intent= 32 Subjects who were enrolled in the study but did not undergo ablation procedure within 60 days from consent signature date
|
Additional Information
Susan Hampson, Clinical Trial Manager
Boston Scientific
Phone: 508-728-5165
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place