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Personalized heart ablation may beat standard treatment for AFib

NCT ID NCT04823299

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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_RECRUITING

    Montreal, Quebec, H3G 1A4, Canada

  • University of Ottawa Heart Institute

    RECRUITING

    Ottawa, Ontario, K1Y 4W7, Canada

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