Which ablation strategy works best for persistent AF? major study seeks answers.
NCT ID NCT04428944
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares three catheter ablation techniques for people with persistent atrial fibrillation (AF), a heart rhythm disorder. About 617 adults having their first ablation will be randomly assigned to one of three groups: isolating the pulmonary veins alone, adding ablation of extra drivers, or isolating the back wall of the left atrium. The goal is to see which strategy best prevents AF from returning within 18 months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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617 people
The number who actually took part.
- Started
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Jun 2021
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AZ Sint-Jan
Ruddershove, Belgium
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Alfred Health
Melbourne, Australia
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Antwerp University Hospital (UZA)
Edegem, Belgium
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Brigham & Women'S Hosptial Inc.
Boston, Massachusetts, 02115, United States
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Canberra Heart Rhythm Foundation
Garran, Australian Capital Territory, Australia
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Clinique du Tonkin
Villeurbanne, France
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Dokkyo Medical University Koshigaya Hospital
Koshigaya, Saitama, Japan
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Hamilton General Hospital
Hamilton, Ontario, L8L 2X2, Canada
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Hospital Clinic Barcelona
Barcelona, Spain
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Hospital St-Joseph
Marseille, France
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Hôpital Fleurimont, CHUS
Sherbrooke, Quebec, J1H 5H3, Canada
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Institut Mutualiste Montsouris
Paris, 75014, France
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Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
Québec, Quebec, G1V 4G5, Canada
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Jikei University School of Med
Tokyo, Japan
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Juntendo University Hospital
Bunkyo City, Tokyo, Japan
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Laurent Macle
Montreal, QC - Québec, H1T 1c8, Canada
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MUHC, McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
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Medical University of Graz
Graz, Austria
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Minamino Cardiovascular Hospital
Tokyo, Japan
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National University Corporation Kobe University
Chūōku, Japan
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Nihon University School of Medicine
Tokyo, Japan
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OLV Hospital Aalst
Aalst, Belgium
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Ordensklinikum Linz GmbH
Linz, Austria
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Ospedale Generale Regionale F. Miulli
Acquaviva delle Fonti, Italy
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Royal Adelaide Hospital and Cardiovascular Centre
Adelaide, Australia
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Royal Jubilee Hospital
Victoria, British Colombia, V8R 1J8, Canada
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Royal Melbourne Hospital
Parkville, Australia
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Southlake Regional Health Center
Newmarket, Ontario, L3Y 2P9, Canada
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St. Paul's Hospital, Vancouver, BC
Vancouver, British Colombia, V6Z 1Y6, Canada
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University of Calgary Foothills
Calgary, Alberta, T2N 4N1, Canada
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University of Ottawa Heart Institute
Ottawa, Quebec, K1Y 4W7, Canada
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Vancouver General Hospital
Vancouver, British Colombia, V5Z 1M9, Canada
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Other studies related to the condition(s) this trial covers.
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