Personalized heart ablation may beat standard treatment for AFib
NCT ID NCT04823299
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times
Summary
This study compares a new, tailored ablation approach to the standard treatment for people with paroxysmal atrial fibrillation (AFib), a common heart rhythm problem. About 556 adults with AFib will be randomly assigned to either standard pulmonary vein isolation or a procedure that targets their specific triggers. The goal is to see which method better prevents AFib from coming back and improves safety.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
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
-
About 556 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2026
- Expected to finish
-
Mar 2030
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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. Age ≥18 years on the date of consent for the trial. 2. Subjects must have paroxysmal AF with at least one episode of AF over the past 12 months (patients on antiarrhythmic medications do not need to satisfy this criterion). At least one episode of AF documented on 12-lead ECG, Holter monitor, Trans-telephonic monitor (TTM) or Loop Recorder. 3. Subjects must be able to provide informed consent. Exclusion Criteria: 1. Persistent and permanent AF. 2. History of previous catheter or surgical ablation for AF, AFl, AT, Atrioventricular Nodal Reentrant Tachycardia (AVNRT), Atrioventricular Reentrant Tachycardia (AVRT). 3. Documented AVNRT, AVRT, AT or Atrial Flutter prior to enrolment in the trial. 4. Previous left atrial (LA) ablation or LA surgery. 5. Previous pulmonary vein stenosis or pulmonary vein stent. 6. Pre-existing hemi-diaphragmatic paralysis. 7. Active intracardiac thrombus. 8. Contraindication to systemic oral anticoagulation therapy 9. Current immunosuppressant therapy (corticosteroids, biologic immunomodulators; such patients may be considered if they can safely discontinue immunosuppressants for three months prior to and for three months following catheter ablation). 10. Reversible causes of AF (e.g., uncontrolled hyperthyroidism, within six months of cardiac surgery). 11. Left ventricular ejection fraction \<35%. 12. NYHA Class 4 heart failure. 13. Hypertrophic cardiomyopathy 14. Significant valve disease (moderate or severe mitral/aortic stenosis or regurgitation). 15. Patients with mechanical mitral prosthetic valves 16. Known adverse reaction to adenosine. 17. Chronic Kidney Disease ≥ Stage 4. 18. Significant congenital heart disease (including atrial septal defects or pulmonary vein abnormalities; however, subjects with patent foramen ovale will not be excluded). 19. Pregnant subjects. 20. Cerebral ischemic event (stroke or transient ischemic attack) in the six months prior to consenting for the trial. 21. History of thromboembolic events in the 6 months preceding enrollment. 22. Currently participating or anticipated to participate in interventional clinical trials of drug, device or biologic agents that could affect the results of this trial. 23. Primary pulmonary hypertension 24. Rheumatic heart disease 25. Thrombocytosis, thrombocytopenia and other hypercoagulable states 26. Active systemic infection 27. Patients with life expectancy less than 12 months. 28. Unwilling or unable to comply fully with study procedures and follow-up.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Atrial fibrillation are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
McGill University Health Center
NOT_YET_RECRUITINGMontreal, Quebec, H3G 1A4, Canada
-
University of Ottawa Heart Institute
RECRUITINGOttawa, Ontario, K1Y 4W7, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next
- Two ways to quiet a racing heart: trial pits hybrid ablation against standard catheter treatment
- Stroke's hidden heart rhythm clue under investigation
- Suture device may get heart patients walking sooner after leg vein procedures
- Two ways to catch a hidden heart rhythm after stroke
- Can an implanted heart monitor catch hidden irregular heartbeats after stroke?