Augmented Wide Area Circumferential Catheter Ablation for Reduction of Atrial Fibrillation Recurrence

NAActive, not recruitingINTERVENTIONAL
Enrollment

411

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2025

Conditions
Atrial Fibrillation
Interventions
PROCEDURE

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.

PROCEDURE

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.

Trial Locations (11)

T2N 4Z6

University of Calgary-Foothills Campus, Calgary

V8T 1Z4

Victoria Cardiac Arrhythmia Trials Inc., Victoria

B3H 3A7

QE II Health Sciences Centre, Halifax

K1Y 4W7

University of Ottawa Heart Institute, Ottawa

M5B 1W8

"St. Michaels Hospital", Toronto

M5G 2C4

Toronto General Hospital-University Health Network, Toronto

Unknown

Sunnybrook Health Sciences Centre, Toronto

H3G 1A4

McGill University Health Center, Montreal

H4J 1C5

CIUSSSNIM-Hopital du Sacre-Coeur de Montreal, Montreal

G1V 4G5

Institut universitaire de cardiologie et de pneumologie de Quebec, Québec

J1H 5N4

Centre hospitalier universitaire de Sherbrooke (CHUS), Sherbrooke

All Listed Sponsors
lead

Ottawa Heart Institute Research Corporation

OTHER

NCT02150902 - Augmented Wide Area Circumferential Catheter Ablation for Reduction of Atrial Fibrillation Recurrence | Biotech Hunter | Biotech Hunter