Strategies for Catheter Ablation of Persistent Atrial Fibrillation: a Randomized, Comparative Study

McGill University Health Centre/Research Institute of the McGill University Health Centre32 sites in 9 countries617 target enrollmentJune 1, 2021

ConditionsAtrial Fibrillation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Enrollment: 617
Locations: 32
Primary Endpoint: Freedom from documented atrial arrhythmia ≥ 30 seconds at 18 months after one ablation procedure on or off antiarrhythmic medications (AAM).
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to compare the efficacy of three different ablation strategies in patients with persistent AF:

PV antral isolation alone (PVAI)
PV antral isolation plus ablation of drivers (PVAI+drivers)
PV antral isolation plus isolation of posterior wall (PVAI+box) All three strategies will employ contemporary catheter ablation technology using more efficient open irrigated tip cooling and contact force sensing.

Registry

clinicaltrials.gov

Start Date

June 1, 2021

End Date

December 2027

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Responsible Party

Principal Investigator

Atul Verma

Cardiologist electrophysiologist

McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria

Inclusion Criteria

•Patients 18 years of age or older
•Patients undergoing first-time ablation procedure for AF
•Patients with persistent AF defined as a sustained episode more than 3 months but less than three years
•Patients with symptomatic AF - symptomatic patients are those who have been aware of their AF at any time within the last 5 years prior to enrolment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms or any combination of the above
•Patients whose AF has been refractory to at least one antiarrhythmic drug
•At least one episode of AF must have been documented by ECG, holter, loop recorder, telemetry, trans-telephonic monitor or implanted device within the last 2 years from enrolment
•Patients must be able and willing to provide written informed consent to participate in the study

Exclusion Criteria

•Patients with paroxysmal AF (no episodes lasting \> 7 days)
•Patients with early persistent AF, sustained episode ≤ 3 months
•Patients with very long lasting persistent AF (episodes lasting \> 3 years)
•Patients with CHA2DS2-VASc score of
•Patients for whom cardioversion or sinus rhythm will never be attempted/pursued
•Patients with AF felt to be secondary to an obvious reversible cause
•Patients with contraindication to oral anticoagulation or systemic anticoagulation with heparin
•Patients with left atrial diameter \> 60 mm in the parasternal long axis view
•Patients who are pregnant

Outcomes

Primary Outcomes

Freedom from documented atrial arrhythmia ≥ 30 seconds at 18 months after one ablation procedure on or off antiarrhythmic medications (AAM).

Time Frame: 18 months

Secondary Outcomes

Freedom from documented atrial arrhythmia > 30 seconds at 18 months after one or more procedures on or off AAM(18 months)
Freedom from documented atrial arrhythmia > 30 seconds at 18 months after one procedure off AAM(18 months)
Each of the above success measures stratified by CHA2DS2-VASc score(18 months)
Freedom from documented AF > 30 seconds at 18 months after one procedure on or off AAM(18 months)
Freedom from documented AF > 30 seconds at 18 months after one or more procedures on or off AAM(18 months)
Freedom from documented atrial arrhythmia > 30 seconds after one or more procedures off AAM(18 months)
Radiofrequency time(18 months)
Freedom from documented AF > 30 seconds at 18 months after one procedure off AAM(18 months)
Freedom from documented AF > 30 seconds at 18 months after one or more procedures off AAM(18 months)
Freedom from documented symptomatic AF > 30 seconds at 18 months after one procedure on or off AAM(18 months)
Quality of life measurements during follow-up using AFEQT questionnaire(6-12-18 months)
Procedure duration(18 months)
Fluoroscopy time (dose)(18 months)
Effect of each strategy on AF cycle length changes and AF termination(18 months)
Correlation of acute AF termination on long-term procedural outcome(18 months)
Freedom from documented symptomatic atrial arrhythmia > 30 seconds after one procedure on or off AAM(18 months)
Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, phrenic nerve palsy, and death(18 months)
Number of repeat procedures(18 months)
Quality of life measurements during follow-up using SF12 questionnaires(6-12-18 months)
Change in AF burden post-ablation procedure (% of time in AF)(18 months)