Clinical trial NCT04428944: STrategies for Catheter Ablation of peRsistent Atrial Fibrlllation
Official title: Strategies for Catheter Ablation of Persistent Atrial Fibrillation: a Randomized, Comparative Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Keywords: ablation
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Montreal Heart Institute
First posted: 2020-06-11
Enrollment: 617
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 of drivers (PVAI+drivers)
3. 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.


Eligibility criteria: Inclusion Criteria:

1. Patients 18 years of age or older
2. Patients undergoing first-time ablation procedure for AF
3. Patients with persistent AF defined as a sustained episode more than 3 months but less than three years
4. 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
5. Patients whose AF has been refractory to at least one antiarrhythmic drug
6. 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
7. Patients must be able and willing to provide written informed consent to participate in the study

Exclusion Criteria:

1. Patients with paroxysmal AF (no episodes lasting \> 7 days)
2. Patients with early persistent AF, sustained episode ≤ 3 months
3. Patients with very long lasting persistent AF (episodes lasting \> 3 years)
4. Patients with CHA2DS2-VASc score of 0.
5. Patients for whom cardioversion or sinus rhythm will never be attempted/pursued
6. Patients with AF felt to be secondary to an obvious reversible cause
7. Patients with contraindication to oral anticoagulation or systemic anticoagulation with heparin
8. Patients with left atrial diameter \> 60 mm in the parasternal long axis view
9. Patients who are pregnant

Primary outcomes:
measure: Freedom from documented atrial arrhythmia ≥ 30 seconds at 18 months after one ablation procedure on or off antiarrhythmic medications (AAM).
timeFrame: 18 months
Secondary outcomes:
measure: Freedom from documented AF > 30 seconds at 18 months after one procedure on or off AAM
timeFrame: 18 months
measure: Freedom from documented AF > 30 seconds at 18 months after one or more procedures on or off AAM
timeFrame: 18 months
measure: Freedom from documented atrial arrhythmia > 30 seconds at 18 months after one or more procedures on or off AAM
timeFrame: 18 months
measure: Freedom from documented AF > 30 seconds at 18 months after one procedure off AAM
timeFrame: 18 months
measure: Freedom from documented atrial arrhythmia > 30 seconds at 18 months after one procedure off AAM
timeFrame: 18 months
measure: Freedom from documented AF > 30 seconds at 18 months after one or more procedures off AAM
timeFrame: 18 months
measure: Freedom from documented atrial arrhythmia > 30 seconds after one or more procedures off AAM
timeFrame: 18 months
measure: Freedom from documented symptomatic AF > 30 seconds at 18 months after one procedure on or off AAM
timeFrame: 18 months
measure: Freedom from documented symptomatic atrial arrhythmia > 30 seconds after one procedure on or off AAM
timeFrame: 18 months
measure: Each of the above success measures stratified by CHA2DS2-VASc score
timeFrame: 18 months
measure: Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, phrenic nerve palsy, and death
timeFrame: 18 months
measure: Procedure duration
timeFrame: 18 months
measure: Fluoroscopy time (dose)
timeFrame: 18 months
measure: Radiofrequency time
timeFrame: 18 months
measure: Number of repeat procedures
timeFrame: 18 months
measure: Effect of each strategy on AF cycle length changes and AF termination
timeFrame: 18 months
measure: Correlation of acute AF termination on long-term procedural outcome
timeFrame: 18 months
measure: Quality of life measurements during follow-up using AFEQT questionnaire
timeFrame: 6-12-18 months
measure: Quality of life measurements during follow-up using SF12 questionnaires
timeFrame: 6-12-18 months
measure: Change in AF burden post-ablation procedure (% of time in AF)
timeFrame: 18 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Women'S Hosptial Inc.
state: Massachusetts
city: Garran
country: Australia
facility: Canberra Heart Rhythm Foundation
state: Australian Capital Territory
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital and Cardiovascular Centre
city: Melbourne
country: Australia
facility: Alfred Health
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
city: Graz,
country: Austria
facility: Medical University of Graz
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH
city: Aalst
country: Belgium
facility: OLV Hospital Aalst
city: Edegem
country: Belgium
facility: Antwerp University Hospital (UZA)
city: Ruddershove
country: Belgium
facility: AZ Sint-Jan
city: Calgary
country: Canada
facility: University of Calgary Foothills
state: Alberta
city: Vancouver,
country: Canada
facility: Vancouver General Hospital
state: British Colombia
city: Vancouver
country: Canada
facility: St. Paul's Hospital, Vancouver, BC
state: British Colombia
city: Victoria
country: Canada
facility: Royal Jubilee Hospital
state: British Colombia
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Newmarket
country: Canada
facility: Southlake Regional Health Center
state: Ontario
city: Montreal
country: Canada
facility: Laurent Macle
state: QC - Québec
city: Montreal
country: Canada
facility: MUHC, McGill University Health Centre
state: Quebec
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Quebec
city: Québec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
state: Quebec
city: Sherbrooke
country: Canada
facility: Hôpital Fleurimont, CHUS
state: Quebec
city: Marseille
country: France
facility: Hospital St-Joseph
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Villeurbanne
country: France
facility: Clinique du Tonkin
city: Acquaviva delle Fonti
country: Italy
facility: Ospedale Generale Regionale F. Miulli
city: Koshigaya
country: Japan
facility: Dokkyo Medical University Koshigaya Hospital
state: Saitama
city: Bunkyo City
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Chuo Ku
country: Japan
facility: National University Corporation Kobe University
city: Tokyo
country: Japan
facility: Jikei University School of Med
city: Tokyo
country: Japan
facility: Minamino Cardiovascular Hospital
city: Tokyo
country: Japan
facility: Nihon University School of Medicine
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Atul Verma, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Montreal Heart Institute
name: Laurent Macle, Dr.
role: PRINCIPAL_INVESTIGATOR
References: