Trial Outcomes & Findings for Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation (NCT NCT01687166)

NCT ID: NCT01687166

Last Updated: 2018-11-21

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 398 participants
• Primary outcome timeframe: 12 Months
• Results posted on: 2018-11-21

Participant Flow

Participant milestones

Measure	Blazer Open-Irrigated Ablation Catheter 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)	Control 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 Blazer Open-Irrigated Ablation Catheter Roll-In Subjects (Not randomized)	Control Roll-In 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
Overall Study STARTED	167	172	56	3
Overall Study COMPLETED	139	145	42	1
Overall Study NOT COMPLETED	28	27	14	2

Reasons for withdrawal

Measure	Blazer Open-Irrigated Ablation Catheter 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)	Control 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 Blazer Open-Irrigated Ablation Catheter Roll-In Subjects (Not randomized)	Control Roll-In 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
Overall Study Attempt subject	2	3	2	0
Overall Study Did not meet eligibility criteria	4	6	1	1
Overall Study Adverse Event	2	1	0	0
Overall Study Physician Decision	3	2	1	0
Overall Study Withdrawal by Subject	11	4	3	0
Overall Study Lost to Follow-up	2	5	1	0
Overall Study Equipment/Device Availability	0	1	0	0
Overall Study Death	1	1	0	0
Overall Study Protocol Violation	1	1	1	0
Overall Study Subject moved out of state	0	1	0	0
Overall Study Patient unable to be compliant	1	0	0	0
Overall Study Physician choice to use different device	1	2	4	0
Overall Study Insurance	0	0	1	1

Baseline Characteristics

Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation

Baseline characteristics by cohort

Measure	Blazer Open-Irrigated Ablation Catheter n=167 Participants 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)	Control n=172 Participants 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 n=56 Participants Blazer Open-Irrigated Ablation Catheter Roll-In Subjects (Not randomized)	Control Roll-In n=3 Participants 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 n=398 Participants Total of all reporting groups
Age, Continuous	60 years STANDARD_DEVIATION 11 • n=5 Participants	59 years STANDARD_DEVIATION 10 • n=7 Participants	62 years STANDARD_DEVIATION 10 • n=5 Participants	61 years STANDARD_DEVIATION 10 • n=4 Participants	60 years STANDARD_DEVIATION 11 • n=21 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	65 Participants n=7 Participants	15 Participants n=5 Participants	1 Participants n=4 Participants	143 Participants n=21 Participants
Sex: Female, Male Male	105 Participants n=5 Participants	107 Participants n=7 Participants	41 Participants n=5 Participants	2 Participants n=4 Participants	255 Participants n=21 Participants
Region of Enrollment Sweden	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Region of Enrollment United States	107 Participants n=5 Participants	112 Participants n=7 Participants	46 Participants n=5 Participants	2 Participants n=4 Participants	267 Participants n=21 Participants
Region of Enrollment United Kingdom	3 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants
Region of Enrollment Australia	6 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	13 Participants n=21 Participants
Region of Enrollment France	3 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants
Region of Enrollment Portugal	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	9 Participants n=21 Participants
Region of Enrollment Germany	18 Participants n=5 Participants	18 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	36 Participants n=21 Participants
Region of Enrollment Spain	27 Participants n=5 Participants	28 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	59 Participants n=21 Participants
Height	173 cm STANDARD_DEVIATION 9 • n=5 Participants	174 cm STANDARD_DEVIATION 9 • n=7 Participants	175 cm STANDARD_DEVIATION 11 • n=5 Participants	175 cm STANDARD_DEVIATION 11 • n=4 Participants	174 cm STANDARD_DEVIATION 10 • n=21 Participants
Weight	89 kg STANDARD_DEVIATION 19 • n=5 Participants	90 kg STANDARD_DEVIATION 22 • n=7 Participants	94 kg STANDARD_DEVIATION 21 • n=5 Participants	79 kg STANDARD_DEVIATION 15 • n=4 Participants	90 kg STANDARD_DEVIATION 21 • n=21 Participants
Resting Heart Rate	71 bpm STANDARD_DEVIATION 19 • n=5 Participants	67 bpm STANDARD_DEVIATION 15 • n=7 Participants	68 bpm STANDARD_DEVIATION 17 • n=5 Participants	68 bpm STANDARD_DEVIATION 7 • n=4 Participants	69 bpm STANDARD_DEVIATION 17 • n=21 Participants
New York Heart Assessment (NYHA) Class I	67 Participants n=5 Participants	64 Participants n=7 Participants	20 Participants n=5 Participants	3 Participants n=4 Participants	154 Participants n=21 Participants
New York Heart Assessment (NYHA) Class II	17 Participants n=5 Participants	13 Participants n=7 Participants	10 Participants n=5 Participants	0 Participants n=4 Participants	40 Participants n=21 Participants
New York Heart Assessment (NYHA) Class Non Heart Failure (HF)	76 Participants n=5 Participants	92 Participants n=7 Participants	24 Participants n=5 Participants	0 Participants n=4 Participants	192 Participants n=21 Participants
New York Heart Assessment (NYHA) Class Not Assessed	7 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	12 Participants n=21 Participants

PRIMARY outcome

Timeframe: 12 Months

Population: Outcome Measures were not assessed for the non-randomized participants.

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.

Outcome measures

Measure	Blazer Open-Irrigated Ablation Catheter n=157 Participants 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)	Control n=164 Participants 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
Procedure-related Complication Free Rate	140 Participants	148 Participants

PRIMARY outcome

Timeframe: Within 12 months of the index procedure

Population: Outcome Measures were not assessed for the non-randomized participants.

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.

Outcome measures

Measure	Blazer Open-Irrigated Ablation Catheter n=157 Participants 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)	Control n=164 Participants 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
Chronic Success Rate	102 Participants	108 Participants

SECONDARY outcome

Timeframe: Acute- During Index Procedure, 20 minutes after confirmation of Pulmonary Vein Isolation

Population: Outcome Measures were not assessed for the non-randomized participants.

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.

Outcome measures

Measure	Blazer Open-Irrigated Ablation Catheter n=157 Participants 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)	Control n=164 Participants 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
Acute Success	155 Participants	163 Participants

Adverse Events

Blazer Open-Irrigated Ablation Catheter Randomized

Serious events: 66 serious events

Other events: 104 other events

Deaths: 1 deaths

FDA Approved Open-Irrigated Ablation Catheter Randomized

Serious events: 65 serious events

Other events: 95 other events

Deaths: 1 deaths

Blazer Open-Irrigated Ablation Catheter Roll-In

Serious events: 19 serious events

Other events: 33 other events

Deaths: 0 deaths

FDA Approved Open-Irrigated Ablation Catheter Roll-In

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Blazer Open-Irrigated Ablation Catheter Randomized n=159 participants at risk 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 Ablation Catheter Randomized n=167 participants at risk 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 n=51 participants at risk 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)	FDA Approved Open-Irrigated Ablation Catheter Roll-In n=1 participants at risk 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
Vascular disorders AV Fistula	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders Adverse medication reaction	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	3.9% 2/51 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders Alcohol dependency	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Arrhythmia (Ablation Procedure)	1.9% 3/159 • Number of events 3 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	1.2% 2/167 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Atrial fibrillation (AF)	11.3% 18/159 • Number of events 18 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	16.2% 27/167 • Number of events 28 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	11.8% 6/51 • Number of events 6 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Atrial flutter (type 1 Isthmus Dependent)	1.9% 3/159 • Number of events 3 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Atrial tachycardia	1.3% 2/159 • Number of events 4 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Atypical Atrial Flutter	3.1% 5/159 • Number of events 6 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	1.2% 2/167 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Atypical atrial flutter	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders Cancer	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	1.8% 3/167 • Number of events 3 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Cardiac arrest	1.3% 2/159 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Cardiac tamponade/perforation	2.5% 4/159 • Number of events 4 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	1.8% 3/167 • Number of events 3 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Cardiomyopathy	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Cerebrovascular accident (CVA)	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders Chest pain	1.9% 3/159 • Number of events 3 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	1.2% 2/167 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Chest pain - Heart failure	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Coronary Artery Disease	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	1.2% 2/167 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders Dizziness	3.1% 5/159 • Number of events 5 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	1.2% 2/167 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Endocrine disorders Endocrine	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders Fluid volume overload( i.e. diuresis, electrolyte imbalance) (Ablation Procedure)	1.3% 2/159 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Gastrointestinal disorders Gastrointestinal	3.1% 5/159 • Number of events 5 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.4% 4/167 • Number of events 4 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	3.9% 2/51 • Number of events 3 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Renal and urinary disorders Genitourinary	5.0% 8/159 • Number of events 9 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders Head, eyes, ears, nose, throat (HEENT)	1.9% 3/159 • Number of events 3 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	1.2% 2/167 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	5.9% 3/51 • Number of events 4 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Heart failure	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Heart failure symptoms - Unspecified	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Vascular disorders Hematoma (Ablation Procedure)	1.3% 2/159 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders Hiccups	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Hypertension	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Hypotension	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders IV infiltrate	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Multiple heart failure symptoms	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders Multiple symptoms	0.63% 1/159 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Musculoskeletal and connective tissue disorders Musculoskeletal	5.7% 9/159 • Number of events 9 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	1.8% 3/167 • Number of events 3 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	3.9% 2/51 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Myocardial infarction	1.3% 2/159 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Other SVT (AVRT, AVNRT, EAT etc.	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Palpitations	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Pericardial Effusion (Ablation Procedure)	1.3% 2/159 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Pericarditis (Ablation Procedure)	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	3.9% 2/51 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Premature atrial contractions (PAC)	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Psychiatric disorders Psychological	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Respiratory, thoracic and mediastinal disorders Pulmonary	6.9% 11/159 • Number of events 12 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	4.2% 7/167 • Number of events 8 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Pulmonary Vein Stenosis - Significant (>70%)	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Pulmonary edema - Heart failure	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Pulmonary embolism (PE)	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Vascular disorders Rectus sheath hematoma	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Renal and urinary disorders Renal	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	3.9% 2/51 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Renal and urinary disorders Renal insufficiency - Heart failure	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Infections and infestations Sanguineous drainage	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Sinus bradycardia	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Syncope	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Infections and infestations Systemic infection	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	1.2% 2/167 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.

Other adverse events

Measure	Blazer Open-Irrigated Ablation Catheter Randomized n=159 participants at risk 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 Ablation Catheter Randomized n=167 participants at risk 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 n=51 participants at risk 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)	FDA Approved Open-Irrigated Ablation Catheter Roll-In n=1 participants at risk 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
Vascular disorders Pseudoaneurysm	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders 1st degree AV block	4.4% 7/159 • Number of events 7 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	3.0% 5/167 • Number of events 5 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders 2nd degree AV block	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Vascular disorders AV Fistula	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders Abnormal laboratory values	3.8% 6/159 • Number of events 6 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	3.9% 2/51 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders Adverse medication reaction	5.7% 9/159 • Number of events 11 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	4.8% 8/167 • Number of events 8 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	5.9% 3/51 • Number of events 3 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders Allergic reaction	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders Allergic reaction (Ablation Procedure)	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders Anesthesia/Sedation related complication (Ablation Procedure)	0.63% 1/159 • Number of events 3 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Angina	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Aortic root atheromatosis	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Arrhythmia (Ablation Procedure)	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Arterial/Venous Thromboembolic Events	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Atrial fibrillation (AF)	13.8% 22/159 • Number of events 22 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	19.2% 32/167 • Number of events 33 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	23.5% 12/51 • Number of events 12 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Atrial flutter (type 1 Isthmus Dependent)	1.9% 3/159 • Number of events 3 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	1.2% 2/167 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	3.9% 2/51 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Atrial tachycardia	6.9% 11/159 • Number of events 11 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	3.6% 6/167 • Number of events 6 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Atypical Atrial Flutter	1.9% 3/159 • Number of events 3 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	1.8% 3/167 • Number of events 3 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Musculoskeletal and connective tissue disorders Back discomfort	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Bradycardia with pauses	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Breathing difficulties	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Brugada syndrome	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders Cancer	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Chest pain	7.5% 12/159 • Number of events 13 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	3.6% 6/167 • Number of events 9 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	5.9% 3/51 • Number of events 3 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Chest pain - Ischemic	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Gastrointestinal disorders Cirrhosis	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Cyst on ascending aorta	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders Dehydration	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Psychiatric disorders Depression	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders Difficulty sleeping	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders Dizziness	1.3% 2/159 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	4.2% 7/167 • Number of events 7 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	3.9% 2/51 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.0% 8/159 • Number of events 8 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Respiratory, thoracic and mediastinal disorders Dyspnea on exertion	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Vascular disorders Edema (Ablation Procedure)	1.3% 2/159 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Endocrine disorders Endocrine	1.3% 2/159 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders Epistaxis	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders Exacerbation of existing condition (Ablation Procedure)	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders Fatigue	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders Fever	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders Fluid retention	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Gastrointestinal disorders Gastrointestinal	5.7% 9/159 • Number of events 10 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	5.4% 9/167 • Number of events 12 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	5.9% 3/51 • Number of events 3 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Gastrointestinal disorders Gastroparesis (Ablation Procedure)	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Renal and urinary disorders Genitourinary	6.3% 10/159 • Number of events 10 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	6.0% 10/167 • Number of events 10 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	7.8% 4/51 • Number of events 4 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Vascular disorders Groin bleed (Ablation Procedure)	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders Groin pain	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders Head, eyes, ears, nose, throat (HEENT)	8.2% 13/159 • Number of events 13 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	7.2% 12/167 • Number of events 14 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	5.9% 3/51 • Number of events 3 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Heart failure symptoms - Unspecified	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Blood and lymphatic system disorders Hematological	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Vascular disorders Hematoma (Ablation Procedure)	4.4% 7/159 • Number of events 7 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.4% 4/167 • Number of events 4 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	7.8% 4/51 • Number of events 4 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders Hemorrhage (Ablation Procedure)	1.3% 2/159 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Hypertension	3.1% 5/159 • Number of events 6 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	1.8% 3/167 • Number of events 3 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Hypotension	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Hypotension (Ablation Procedure)	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Gastrointestinal disorders Increased GERD	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders Integumentary	3.1% 5/159 • Number of events 5 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	1.8% 3/167 • Number of events 3 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Intracardiac thrombus with no thromboembolic event	1.3% 2/159 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Intraventricular conduction delay	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Junctional ectopic rhythm	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Long QT	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Infections and infestations Lyme disease	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Multiple heart failure symptoms	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Musculoskeletal and connective tissue disorders Musculoskeletal	4.4% 7/159 • Number of events 7 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	4.8% 8/167 • Number of events 8 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	3.9% 2/51 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Nervous system disorders Neurological	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	3.0% 5/167 • Number of events 5 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Infections and infestations Non-toxic LLE cellulitis	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Nonsustained ventricular tachycardia (NSVT)	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Other SVT (AVRT, AVNRT, EAT etc.	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	5.9% 3/51 • Number of events 3 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Nervous system disorders Pain neuromuscular/non cardiovascular (Ablation Procedure)	1.3% 2/159 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Palpitations	2.5% 4/159 • Number of events 4 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	3.6% 6/167 • Number of events 7 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	3.9% 2/51 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Pericardial Effusion (Ablation Procedure)	1.9% 3/159 • Number of events 3 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	1.8% 3/167 • Number of events 3 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Pericardial effusion	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Pericardial effusion - Unrelated to procedure	1.3% 2/159 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Vascular disorders Peripheral edema	1.9% 3/159 • Number of events 3 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Vascular disorders Peripheral edema - Heart failure	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Nervous system disorders Peripheral neuropathy	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders Physical trauma	1.9% 3/159 • Number of events 3 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	1.2% 2/167 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Pleuritis (Ablation Procedure)	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	3.9% 2/51 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Premature atrial contractions (PAC)	3.1% 5/159 • Number of events 5 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	1.2% 2/167 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Premature ventricular contractions (PVC)	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	1.8% 3/167 • Number of events 3 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Psychiatric disorders Psychological	1.3% 2/159 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	1.2% 2/167 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Respiratory, thoracic and mediastinal disorders Pulmonary	6.9% 11/159 • Number of events 14 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	5.4% 9/167 • Number of events 9 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Pulmonary Vein Stenosis - Mild or Moderate (<70%)	2.5% 4/159 • Number of events 4 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	3.9% 2/51 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Pulmonary Vein Stenosis - Significant (>70%)	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	1.2% 2/167 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Renal and urinary disorders Renal	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Right bundle branch block	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Sinus arrhythmia	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Sinus bradycardia	3.1% 5/159 • Number of events 5 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	3.6% 6/167 • Number of events 6 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	3.9% 2/51 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Sinus tachycardia	5.0% 8/159 • Number of events 8 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.4% 4/167 • Number of events 4 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
General disorders Sore throat	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	1.8% 3/167 • Number of events 3 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Vascular disorders Swollen groin	1.3% 2/159 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Syncope	1.3% 2/159 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Tachycardia (Ablation Procedure)	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Thrombus (No embolism) (Ablation Procedure)	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	2.0% 1/51 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Typical atrial flutter	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Respiratory, thoracic and mediastinal disorders Vagal denervation symptoms	0.00% 0/159 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.60% 1/167 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Cardiac disorders Ventricular tachycardia (VT)	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.
Eye disorders Visual Blurring/Disturbances (Ablation Procedure)	0.63% 1/159 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/167 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/51 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.	0.00% 0/1 • Adverse events were collected from enrollment to end of follow-up ~12Months. Adverse event data is reported for treatment and attempt subjects.

Additional Information

Clinical Trial Manager

Boston Scientific

Phone: 617-218-3849

Email: weismanm@bsci.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER