Trial Outcomes & Findings for Clinical Evaluation of the Blazer® Open-Irrigated Catheter for Treatment of Type 1 Atrial Flutter (NCT NCT01253200)

Last Updated: 2018-03-19

Results Overview

A procedure-related complication is defined as an adverse event that results in death, a life-threatening complication, or a persistent or significant disability/incapacity or required intervention to prevent a permanent impairment of a body function or damage to a body structure. All adverse events related to the investigational or control devices or ablation procedure will be considered procedure-related events.

Recruitment status

COMPLETED

Study phase

Target enrollment

302 participants

Primary outcome timeframe

7 days post-procedure

Results posted on

2018-03-19

Participant Flow

Subjects were recruited from referring physicians for ablation for type 1 atrial flutter

Subjects were excluded if there were no documented episodes of atrial flutter or inclusion criteria were not met. Roll-in subjects were not randomized.

Participant milestones

Participant milestones
Measure	Randomized Blazer® Open-Irrigated Ablation Catheter Randomized Patients treated with the Blazer® Open-Irrigated Ablation Catheter Blazer® Open-Irrigated Ablation Catheter: Blazer® Open-Irrigated Ablation Catheter	Randomized Control Catheter Randomized patients treated with an open-irrigated radiofrequency ablation catheter that has received FDA market approval for the treatment of type 1 atrial flutter Control Catheter: Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter	Roll-in Blazer Open Irrigated Subjects The use of the Blazer-Open Irrigated Catheter was required after the second study suspension. Previously enrolled subjects prior to suspension were also classified as Roll-in subjects; not counted in endpoint analysis.	Roll-in Control Catheter The use of the Control Catheter was optional after the second study suspension in a Roll-in subject. Previously enrolled subjects prior to suspension were also classified as Roll-in subjects; not counted in endpoint analysis.	Not Randomized to Any Treatment Group Subjects Five subjects were not Randomized to any treatment group and were not Roll-in subjects.
Overall Study STARTED	125	125	30	17	5
Overall Study Procedure	109	111	28	12	0
Overall Study 10 Day Follow-up	106	111	28	12	0
Overall Study 3 Month Follow-up	104	106	28	12	0
Overall Study COMPLETED	104	106	28	12	0
Overall Study NOT COMPLETED	21	19	2	5	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Randomized Blazer® Open-Irrigated Ablation Catheter Randomized Patients treated with the Blazer® Open-Irrigated Ablation Catheter Blazer® Open-Irrigated Ablation Catheter: Blazer® Open-Irrigated Ablation Catheter	Randomized Control Catheter Randomized patients treated with an open-irrigated radiofrequency ablation catheter that has received FDA market approval for the treatment of type 1 atrial flutter Control Catheter: Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter	Roll-in Blazer Open Irrigated Subjects The use of the Blazer-Open Irrigated Catheter was required after the second study suspension. Previously enrolled subjects prior to suspension were also classified as Roll-in subjects; not counted in endpoint analysis.	Roll-in Control Catheter The use of the Control Catheter was optional after the second study suspension in a Roll-in subject. Previously enrolled subjects prior to suspension were also classified as Roll-in subjects; not counted in endpoint analysis.	Not Randomized to Any Treatment Group Subjects Five subjects were not Randomized to any treatment group and were not Roll-in subjects.
Overall Study Death	1	0	0	0	0
Overall Study Lost to Follow-up	1	1	0	0	0
Overall Study Withdrawal by Subject	2	0	0	0	0
Overall Study Protocol Violation	1	4	0	0	5
Overall Study intents	10	10	1	3	0
Overall Study Attempts	6	4	1	2	0

Baseline Characteristics

Clinical Evaluation of the Blazer® Open-Irrigated Catheter for Treatment of Type 1 Atrial Flutter

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Randomized Blazer® Open-Irrigated Ablation Catheter n=125 Participants Patients randomized to treatment with the Blazer® Open-Irrigated Ablation Catheter	Randomized Control Catheter n=125 Participants Patients randomized to treatment with an open-irrigated radiofrequency ablation catheter that has received FDA market approval for the treatment of type 1 atrial flutter Control Catheter: Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter	Roll-In Blazer® Open-Irrigated Ablation Catheter n=30 Participants The use of the Blazer-Open Irrigated Catheter was required after the second study suspension. Previously enrolled subjects prior to suspension were also classified as Roll-in subjects; not counted in endpoint analysis.	Roll-In Control Catheter n=17 Participants The use of the Control Catheter was optional after the second study suspension in a Roll-in subject. Previously enrolled subjects prior to suspension were also classified as Roll-in subjects; not counted in endpoint analysis	Not Randomized to Any Treatment Group n=5 Participants Subjects not Randomized to any treatment group and were not Roll-in subjects	Total n=302 Participants Total of all reporting groups
Age, Continuous	65 years STANDARD_DEVIATION 11 • n=5 Participants	66 years STANDARD_DEVIATION 10 • n=7 Participants	69 years STANDARD_DEVIATION 10 • n=5 Participants	66 years STANDARD_DEVIATION 9 • n=4 Participants	72 years STANDARD_DEVIATION 11 • n=21 Participants	65.73 years STANDARD_DEVIATION 10.54 • n=8 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	29 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	62 Participants n=8 Participants
Sex: Female, Male Male	102 Participants n=5 Participants	96 Participants n=7 Participants	26 Participants n=5 Participants	13 Participants n=4 Participants	3 Participants n=21 Participants	240 Participants n=8 Participants
Region of Enrollment United States	125 participants n=5 Participants	125 participants n=7 Participants	30 participants n=5 Participants	17 participants n=4 Participants	5 participants n=21 Participants	302 participants n=8 Participants

PRIMARY outcome

Timeframe: 7 days post-procedure

Population: The primary outcome analysis is for a further subset of Randomized subjects only who underwent RF ablation; 220 subjects out of the total 302 subjects. All is consistent with the approved statistical analysis plan and information publicly available in the FDA Summary of Safety and Effectiveness Data (SSED) and BSC labeling, the Directions for Use.

Outcome measures

Outcome measures
Measure	Blazer® Open-Irrigated Ablation Catheter n=109 Participants Patients treated with the Blazer® Open-Irrigated Ablation Catheter Blazer® Open-Irrigated Ablation Catheter: Blazer® Open-Irrigated Ablation Catheter	Control Catheter n=111 Participants Patients treated with an open-irrigated radiofrequency ablation catheter that has received FDA market approval for the treatment of type 1 atrial flutter Control Catheter: Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter
Procedure-related Complication-free Rate	92.7 percentage of subjects	98.2 percentage of subjects

PRIMARY outcome

Timeframe: 30 minutes after the last radiofrequency application in the cavo-tricuspid isthmus

Acute success is defined as demonstration of bidirectional cavo-tricuspid isthmus block (ie, lack of electrophysiological conduction through the isthmus) 30 minutes after the last radiofrequency application in the cavo-tricuspid isthmus with the investigational or control catheter only.

Outcome measures

Outcome measures
Measure	Blazer® Open-Irrigated Ablation Catheter n=109 Participants Patients treated with the Blazer® Open-Irrigated Ablation Catheter Blazer® Open-Irrigated Ablation Catheter: Blazer® Open-Irrigated Ablation Catheter	Control Catheter n=111 Participants Patients treated with an open-irrigated radiofrequency ablation catheter that has received FDA market approval for the treatment of type 1 atrial flutter Control Catheter: Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter
Acute Success Rate	87.2 percentage of success	89.2 percentage of success

SECONDARY outcome

Timeframe: 3 months post-procedure

Population: The secondary outcome analysis is for a subset of Randomized subjects only who underwent RF ablation; 220 subjects out of the total 302 subjects. All is consistent with the approved statistical analysis plan and information publicly available in the FDA Summary of Safety and Effectiveness Data (SSED) and BSC labeling, the Directions for Use.

Chronic success is defined as freedom from recurrence of type 1 atrial flutter at 3-months post-procedure for all treated patients.

Outcome measures

Outcome measures
Measure	Blazer® Open-Irrigated Ablation Catheter n=109 Participants Patients treated with the Blazer® Open-Irrigated Ablation Catheter Blazer® Open-Irrigated Ablation Catheter: Blazer® Open-Irrigated Ablation Catheter	Control Catheter n=111 Participants Patients treated with an open-irrigated radiofrequency ablation catheter that has received FDA market approval for the treatment of type 1 atrial flutter Control Catheter: Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter
Chronic Success Rate: All Treated Patients	74.3 percentage of subjects	80.2 percentage of subjects

SECONDARY outcome

Timeframe: 3-months post-procedure

Population: The secondary outcome analysis is for a further subset of Randomized subjects only who underwent RF ablation and classified as acute success; 194 of the total 302 subjects. All consistent with approved statistical analysis plan and information publicly available in the FDA SSED and BSC the Directions for Use.

Chronic success is defined as demonstration of acute success and freedom from recurrence of type 1 atrial flutter at 3-months post-procedure. Only randomized patients with acute procedural success will be included in this endpoint.

Outcome measures

Outcome measures
Measure	Blazer® Open-Irrigated Ablation Catheter n=95 Participants Patients treated with the Blazer® Open-Irrigated Ablation Catheter Blazer® Open-Irrigated Ablation Catheter: Blazer® Open-Irrigated Ablation Catheter	Control Catheter n=99 Participants Patients treated with an open-irrigated radiofrequency ablation catheter that has received FDA market approval for the treatment of type 1 atrial flutter Control Catheter: Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter
Chronic Success Rate: Acute Success Patients	85.3 percentage of chronic success	89.9 percentage of chronic success

Adverse Events

Randomized Blazer® Open-Irrigated Ablation Catheter

Serious events: 7 serious events

Other events: 50 other events

Deaths: 1 deaths

Randomized Control Catheter

Serious events: 2 serious events

Other events: 61 other events

Deaths: 0 deaths

Roll-in Blazer® Open-Irrigated Ablation Catheter

Serious events: 5 serious events

Other events: 16 other events

Deaths: 0 deaths

Roll-in Control Catheter

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Non-Randomized to Any Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Randomized Blazer® Open-Irrigated Ablation Catheter n=109 participants at risk Randomized patients treated with the Blazer® Open-Irrigated Ablation Catheter (procedure patients) Blazer® Open-Irrigated Ablation Catheter: Blazer® Open-Irrigated Ablation Catheter Note that only subjects at risk for an adverse event (treated subjects) are included in the calculation of the adverse event rates	Randomized Control Catheter n=111 participants at risk Randomized patients treated with an open-irrigated radiofrequency ablation catheter that has received FDA market approval for the treatment of type 1 atrial flutter (procedure patients) Control Catheter: Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter Note that only subjects at risk for an adverse event (treated subjects) are included in the calculation of the adverse event rates	Roll-in Blazer® Open-Irrigated Ablation Catheter n=28 participants at risk Roll-in patients treated with the Blazer® Open-Irrigated Ablation Catheter (procedure patients) Blazer® Open-Irrigated Ablation Catheter: Blazer® Open-Irrigated Ablation Catheter Note that only subjects at risk for an adverse event (treated subjects) are included in the calculation of the adverse event rates	Roll-in Control Catheter n=12 participants at risk Roll-in patients treated with an open-irrigated radiofrequency ablation catheter that has received FDA market approval for the treatment of type 1 atrial flutter (procedure patients) Control Catheter: Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter Note that only subjects at risk for an adverse event (treated subjects) are included in the calculation of the adverse event rates	Non-Randomized to Any Treatment Group n=5 participants at risk Five subjects were not randomized to any treatment group and were not Roll-in subjects. Therefore, these five subjects were not treated with the Blazer Open-irrigated catheter or a Control catheter. Note that only subjects at risk for an adverse event (treated subjects) are included in the calculation of the adverse event rates
Nervous system disorders Cardiovascular Accident (CVA) Resulting in Death	0.92% 1/109 • Number of events 1 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/111 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/28 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/12 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/5 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.
Cardiac disorders Hypotension	1.8% 2/109 • Number of events 2 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/111 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/28 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/12 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/5 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.
Cardiac disorders Congestive Heart Failure	0.00% 0/109 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.90% 1/111 • Number of events 1 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/28 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/12 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/5 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.
Nervous system disorders Vasovagal Reaction	0.92% 1/109 • Number of events 1 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/111 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/28 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/12 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/5 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.
Cardiac disorders Junctional Rhythm	0.92% 1/109 • Number of events 1 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/111 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/28 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/12 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/5 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.
Vascular disorders Pseudoaneurysm with Hematoma	0.00% 0/109 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.90% 1/111 • Number of events 1 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/28 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/12 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/5 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.
Vascular disorders Pseudoaneurysm	0.92% 1/109 • Number of events 1 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/111 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/28 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/12 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/5 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.
Infections and infestations Urinary Tract Infection	0.92% 1/109 • Number of events 1 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/111 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/28 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/12 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/5 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.
Cardiac disorders 3rd Degree Heart Block	0.00% 0/109 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/111 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/28 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	8.3% 1/12 • Number of events 1 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/5 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.
Cardiac disorders Atrial Fibrillation	0.00% 0/109 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/111 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	7.1% 2/28 • Number of events 2 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/12 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/5 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.
Cardiac disorders Chest pain iscemic	0.00% 0/109 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/111 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	3.6% 1/28 • Number of events 1 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/12 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/5 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.
Cardiac disorders Myocardial perforation with tamponade	0.00% 0/109 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/111 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	3.6% 1/28 • Number of events 1 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/12 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/5 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.
Cardiac disorders Nonsustained ventricular tachycardia	0.00% 0/109 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/111 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	3.6% 1/28 • Number of events 1 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/12 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/5 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.
Cardiac disorders Sinus Bradycardia	0.00% 0/109 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/111 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/28 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	8.3% 1/12 • Number of events 1 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/5 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.

Other adverse events

Other adverse events
Measure	Randomized Blazer® Open-Irrigated Ablation Catheter n=109 participants at risk Randomized patients treated with the Blazer® Open-Irrigated Ablation Catheter (procedure patients) Blazer® Open-Irrigated Ablation Catheter: Blazer® Open-Irrigated Ablation Catheter Note that only subjects at risk for an adverse event (treated subjects) are included in the calculation of the adverse event rates	Randomized Control Catheter n=111 participants at risk Randomized patients treated with an open-irrigated radiofrequency ablation catheter that has received FDA market approval for the treatment of type 1 atrial flutter (procedure patients) Control Catheter: Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter Note that only subjects at risk for an adverse event (treated subjects) are included in the calculation of the adverse event rates	Roll-in Blazer® Open-Irrigated Ablation Catheter n=28 participants at risk Roll-in patients treated with the Blazer® Open-Irrigated Ablation Catheter (procedure patients) Blazer® Open-Irrigated Ablation Catheter: Blazer® Open-Irrigated Ablation Catheter Note that only subjects at risk for an adverse event (treated subjects) are included in the calculation of the adverse event rates	Roll-in Control Catheter n=12 participants at risk Roll-in patients treated with an open-irrigated radiofrequency ablation catheter that has received FDA market approval for the treatment of type 1 atrial flutter (procedure patients) Control Catheter: Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter Note that only subjects at risk for an adverse event (treated subjects) are included in the calculation of the adverse event rates	Non-Randomized to Any Treatment Group n=5 participants at risk Five subjects were not randomized to any treatment group and were not Roll-in subjects. Therefore, these five subjects were not treated with the Blazer Open-irrigated catheter or a Control catheter. Note that only subjects at risk for an adverse event (treated subjects) are included in the calculation of the adverse event rates
Cardiac disorders Ablation related Events	5.5% 6/109 • Number of events 7 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	10.8% 12/111 • Number of events 13 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	10.7% 3/28 • Number of events 3 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	16.7% 2/12 • Number of events 2 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/5 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.
Cardiac disorders Cardiovascular related	37.6% 41/109 • Number of events 56 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	46.8% 52/111 • Number of events 97 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	50.0% 14/28 • Number of events 18 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	41.7% 5/12 • Number of events 5 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/5 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.
General disorders Non-cardiovascular	10.1% 11/109 • Number of events 12 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	9.9% 11/111 • Number of events 16 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	14.3% 4/28 • Number of events 4 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	8.3% 1/12 • Number of events 1 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.	0.00% 0/5 • Within 3 months of the index RF ablation procedure Only subjects at risk for adverse events, (Randomized and Roll-in for the Blazer Open-irrigated catheter and the Control Catheters) are included in the calculation of the adverse event rate. The calculation of the adverse event rate does NOT include the five Non-randomized subjects who were NOT treated with either the Blazer Open-irrigated catheter or the Control Catheter.

Additional Information

Timothy Meyer; Director of Clinical Trials

Boston Scientific

Phone: 651 581 3425

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place