Trial Outcomes & Findings for Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL) (NCT NCT00984204)

NCT ID: NCT00984204

Last Updated: 2019-02-19

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 188 participants
• Primary outcome timeframe: 7 days
• Results posted on: 2019-02-19

Participant Flow

Participant milestones

Measure	Treatment Arm
Overall Study STARTED	188
Overall Study COMPLETED	173
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Measure	Treatment Arm
Overall Study Death	1
Overall Study Lost to Follow-up	4
Overall Study Lack of Efficacy	10

Baseline Characteristics

Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)

Baseline characteristics by cohort

Measure	Treatment Arm n=188 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	77 Participants n=93 Participants
Age, Categorical >=65 years	111 Participants n=93 Participants
Age, Continuous	66.47 years STANDARD_DEVIATION 11.16 • n=93 Participants
Sex: Female, Male Female	28 Participants n=93 Participants
Sex: Female, Male Male	160 Participants n=93 Participants
Region of Enrollment United States	162 participants n=93 Participants
Region of Enrollment Canada	26 participants n=93 Participants

PRIMARY outcome

Timeframe: 7 days

Outcome measures

Measure	Treatment Arm n=188 Participants
Primary Safety- Incidence of Intra Procedural Serious Cardiac Adverse Events Occuring Within 7 Days of Post-procedure, Regardless of Whether a Determination Can be Made Regarding Device Relatedness.	12 participants Interval 3.34 to 10.88

PRIMARY outcome

Timeframe: 30 mins

Outcome measures

Measure	Treatment Arm n=188 Participants
Primary Efficacy- Bidirectional Block in the Cavo-tricuspid Isthmus and Non-inducibility of Typical Atrial Flutter at Least 30 Minutes Following the Last RF Ablation With the Cool Path Duo Ablation Catheter System is Obtained.	181 participants Interval 93.57 to 98.98

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Measure	Treatment Arm n=188 Participants
Secondary Efficacy- Freedom From Recurrence of Typical Atrial Flutter up to 3 Months Post Procedure	173 participants Interval 91.24 to 97.83

Adverse Events

Treatment Arm

Serious events: 12 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment Arm n=188 participants at risk
Cardiac disorders Cardiac Arrhythmia	1.6% 3/188 • Composite SAEs within 7 days
Cardiac disorders Congestive Heart Failure	1.1% 2/188 • Composite SAEs within 7 days
Nervous system disorders Syncope	0.53% 1/188 • Composite SAEs within 7 days
Injury, poisoning and procedural complications Pericarditis	0.53% 1/188 • Composite SAEs within 7 days
Vascular disorders Coronary Artery Disease	0.53% 1/188 • Composite SAEs within 7 days
Cardiac disorders Atrial Fibrillation	0.53% 1/188 • Number of events 1 • Composite SAEs within 7 days
Vascular disorders Hypotension	1.6% 3/188 • Composite SAEs within 7 days

Other adverse events

Measure	Treatment Arm n=188 participants at risk
Cardiac disorders Cardiac Arrhthymia	10.6% 20/188 • Composite SAEs within 7 days
Cardiac disorders Palpitations	2.1% 4/188 • Composite SAEs within 7 days

Additional Information

Nabil Kanaan

St. Jude Medical

Phone: 949-769-5000

Email: nkanaan@sjm.com

Results disclosure agreements

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