Randomized Trial of Segmental Versus Circumferential Antral Ablation in Paroxysmal Atrial Fibrillation (CABLE)
Recruitment status was: Recruiting
|Paroxysmal Atrial Fibrillation||Procedure: Circumferential Antral Ablation Procedure: Segmental Antral ablation|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Trial of Segmental Versus Circumferential Antral Ablation in Paroxysmal Atrial Fibrillation|
- Freedom from atrial fibrillation [ Time Frame: six months ]Symptomatic atrial fibrillation recurrence (without anti-arrhythmic med's)
- Procedure time [ Time Frame: (4-6) hours From the time patient is draped to the time electrophysiology catheters are removed from the body (same day in the electrophysiology lab) ]How long did the procedure take?
- Ablation Time [ Time Frame: (4-6 hours) Measured during the procedure. ]A cumulative measurement of the duration of ablation used during the pulmonary vein isolation procedure.
- Fluoroscopy Time [ Time Frame: (4-6 Hours) Measured during the procedure. ]A cumulative measurement of flouroscopy time during the pulmonary vein isolation procedure.
- complications [ Time Frame: 6 months ]Did the patient experience any complication during the actual pulmonary vein isolation procedure or complication during follow-up related to the procedure?
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Circumferential
Completing a complete circle of RF lesions around the left and right pulmonary veins
Procedure: Circumferential Antral Ablation
The goal is to complete ablation in all segments around the pulmonary veins until a circle of ablation lesions is created in the antrum with at least 30 seconds of ablation, 25W on the posterior surface, 30W on the anterior surface at each site, and change in the local electrogram. Entry and Exit block will be confirmed in each vein. The left superior pulmonary vein and left inferior pulmonary vein will be isolated with one circle, and the right superior and right inferior pulmonary veins will be isolated with one circle.
Isolating the left and right pulmonary veins through RF lesions with a segmental antral approach.
Procedure: Segmental Antral ablation
If the patient is in atrial fibrillation, ablation will begin in the segment with the highest frequency signals in the pulmonary vein antrum. If the patient is in sinus rhythm, mapping and ablation will occur during coronary sinus pacing. Segments with the earliest signals in the Lasso catheter will be targeted, and reassessed after each ablation lesion. This will continue in a segmental fashion on the antrum until pulmonary vein isolation is achieved. Lasso should be moved between veins between lesions to assess the earliest electrogram. Entry and exit block will be confirmed at each vein.
This is a randomized controlled non-inferiority designed trial.
Patients will stop their anti-arrhythmic drugs 2 months post procedure. Follow-ups will involve clinical assessment, holter and/or loop recorders at 3, 6, 9, and 12 month intervals.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01260220
|Contact: Lorne J Gula, MD, MScfirstname.lastname@example.org|
|Contact: Ellie C Hogg, BSc||519-685-8500 ext email@example.com|
|London Health Science Centre||Recruiting|
|London, Ontario, Canada, N6A 5A5|
|Contact: Lorne J Gula, MD, MSc 519-663-3746 firstname.lastname@example.org|
|Contact: Ellie Hogg, BSc 519-685-8500 ext 32490 email@example.com|
|Sub-Investigator: Allan Skanes, MD,FRCPC|
|Sub-Investigator: Peter Leong-Sit, MD,FRCPC|
|Sub-Investigator: Raymond Sy, MD,FRCPC|
|Sub-Investigator: Cathy Bently, BScN|
|Sub-Investigator: Ellie Hogg, BSc|
|Principal Investigator:||Lorne J Gula, MD||University of Western Ontario, Canada|