Status:
ACTIVE_NOT_RECRUITING
STrategies for Catheter Ablation of peRsistent Atrial Fibrlllation
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
Montreal Heart Institute
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to compare the efficacy of three different ablation strategies in patients with persistent AF: 1. PV antral isolation alone (PVAI) 2. PV antral isolation plus ablation ...
Eligibility Criteria
Inclusion
- 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
- 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 0.
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2027
Estimated Enrollment :
617 Patients enrolled
Trial Details
Trial ID
NCT04428944
Start Date
June 1 2021
End Date
December 1 2027
Last Update
February 6 2025
Active Locations (32)
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1
Brigham & Women'S Hosptial Inc.
Boston, Massachusetts, United States, 02115
2
Canberra Heart Rhythm Foundation
Garran, Australian Capital Territory, Australia
3
Royal Adelaide Hospital and Cardiovascular Centre
Adelaide, Australia
4
Alfred Health
Melbourne, Australia