411
Participants
Start Date
March 31, 2015
Primary Completion Date
September 30, 2025
Study Completion Date
September 30, 2025
Wide area circumferential catheter ablation
All subjects in the control arm of the trial will undergo wide area circumferential catheter ablation (WACA; lesions delivered 1-2 cm away from the pulmonary vein ostium) around all four pulmonary veins to the endpoint of electrical isolation (demonstrated by entry and exit block using differential pacing). Catheter ablation will be performed using contact force (CF) and electroanatomical mapping system guidance (average CF \>10g, FTI \> 500 g-sec and minimum ablation duration \>10 sec). Dormant pulmonary vein conduction will be tested using adenosine, after completion of the lesion set, and additional lesions will be delivered to eliminate dormant PV conduction.
Augmented- wide area circumferential ablation procedure
Subjects in this group will have WACA performed as described for WACA. Following completion of the WACA procedure a second set of circumferential ablation lesions will be delivered around the first set of ablation lesions. The ablation catheter tip will be positioned at each of the ablation lesions along the first WACA line and then moved away (from the PV ostia) until healthy, non ablated tissue is recorded from the catheter tip. Energy will be delivered using CF and FTI data as described previously. Once the first WACA ablation line has been completely duplicated the procedure will be deemed complete. In case PV isolation is not achieved after the first WACA lesion set repeat electrophysiologic testing will be performed to determine whether the augmented-WACA procedure was successful in achieving PV isolation.
University of Calgary-Foothills Campus, Calgary
Victoria Cardiac Arrhythmia Trials Inc., Victoria
QE II Health Sciences Centre, Halifax
University of Ottawa Heart Institute, Ottawa
"St. Michaels Hospital", Toronto
Toronto General Hospital-University Health Network, Toronto
Sunnybrook Health Sciences Centre, Toronto
McGill University Health Center, Montreal
CIUSSSNIM-Hopital du Sacre-Coeur de Montreal, Montreal
Institut universitaire de cardiologie et de pneumologie de Quebec, Québec
Centre hospitalier universitaire de Sherbrooke (CHUS), Sherbrooke
Ottawa Heart Institute Research Corporation
OTHER