Therapeutic Outcomes Using Contact Force Handling During Atrial Fibrillation Ablation
- Conditions
- Persistent Atrial Fibrillation
- Registration Number
- NCT01851525
- Lead Sponsor
- Southlake Regional Health Centre
- Brief Summary
Catheter ablation has emerged as an effective therapy for atrial fibrillation (AF). However, achievement of complete\& durable isolation of the pulmonary veins (PVs) is challenging, primary limited both by operator experience and also the limits of currently available ablation technology. Direct contact force sensing (CFS) is a novel technology that may help to ensure adequate lesion delivery. CFS may also help to improve the safety profile of catheter ablation. The purpose of this study is to compare two strategies of wide antral PV isolation plus linear ablation for persistent AF:
1. guided by contact force sensing (CFS) OR
2. blinded to contact force sensing (CFS) - i.e. standard approach
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Total cumulative radio frequency (RF) delivery time 12 months Total cumulative RF delivery time for all ablation procedures performed during the study period (12 mo)
- Secondary Outcome Measures
Name Time Method Reduction in atrial arrhythmia burden by >90% 12 months Freedom from AF or atrial arrhythmia >30 sec 12 months Freedom from AF or atrial arrhythmia \>30 sec at 12 months post-initial ablation
Ability to achieve PV isolation with a single ring of lesions around each PV 6 hours Ability to achieve PV isolation with a single ring of lesions around each PV
Ability to achieve linear ablation with complete conduction block on the first attempt 6 hours Ability to achieve linear ablation with complete conduction block on the first attempt
Number & location of conduction gaps after initial circumferential ablation lines 6 hours Number \& location of conduction gaps after initial circumferential ablation lines during first ablation procedure
Number & location of conduction gaps after initial linear ablation 6 hours Number \& location of conduction gaps after initial linear ablation during first ablation procedure
Time required for successful PV isolation 12 months Time required for successful PV isolation taking into consideration all ablation procedures
Total fast anatomical mapping (FAM) time 12 months Total FAM time taking into consideration all ablation procedures
Time required for successful linear ablation 12 months Time required for successful linear ablation taking into consideration all ablation procedures
FAM volume 12 months FAM volume of CFS vs non-CFS guided maps
Freedom from ablation-related major adverse events at 90 days post-ablation - specifically perforation, stroke/thromboembolism, esophageal injury, and symptomatic PV stenosis 90 days Freedom from ablation-related major adverse events at 90 days post-ablation - specifically perforation, stroke/thromboembolism, esophageal injury, and symptomatic PV stenosis
Incidence of conduction gaps around pulmonary veins 12 months Incidence of conduction gaps around pulmonary veins and correlation to force measures in those gaps
Freedom from atrial arrhythmia > 30 sec 12 months Freedom from atrial arrhythmia \> 30 sec at 12 months after one procedure
Freedom from atrial arrhythmia > 30 sec after one or two procedures 12 months Freedom from atrial arrhythmia \> 30 sec at 12 months after one or two procedures
Incidence of repeat ablation procedures 12 months
Trial Locations
- Locations (4)
Vancouver Island Cardiac Arrhythmia Clinic
🇨🇦Victoria, British Columbia, Canada
Southlake Regional Health Centre
🇨🇦Newmarket, Ontario, Canada
Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada
Laval University Cardiac and Pulmonary Institute
🇨🇦Quebec City, Quebec, Canada
Vancouver Island Cardiac Arrhythmia Clinic🇨🇦Victoria, British Columbia, Canada