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Tailored heart ablation may beat standard treatment for stubborn AFib

NCT ID NCT03347227

Disease control Sponsor: Ottawa Heart Institute Research Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether a personalized catheter ablation approach, guided by mapping low-voltage areas in the heart, works better than standard ablation for people with persistent atrial fibrillation (AFib). About 510 adults with persistent AFib will be randomly assigned to receive either the tailored ablation plus standard pulmonary vein isolation, or standard isolation alone. The main goal is to see if the personalized method reduces episodes of AFib, atrial flutter, or atrial tachycardia over 18 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
catheter ablation (a procedure that uses heat or cold to destroy small areas of heart tissue causing abnormal rhythms)
What this could lead to
If successful, this could offer a more effective, personalized treatment for persistent atrial fibrillation, reducing recurrence and the need for repeat procedures.
What could go wrong
This is a mid-stage trial, and the personalized approach may not prove better than standard ablation. Risks include procedure-related complications like stroke, bleeding, or heart perforation.

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 510 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2018

Expected to finish

Dec 2027

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; 2. Subjects with symptomatic persistent AF AND clinically indicated catheter ablation for AF; 3. Persistent AF defined as a sustained episode beyond 3 months in duration; 4. At least one episode of AF must have been documented on 12-lead ECG, Holter monitor, loop monitor or trans-telephonic monitor (TTM) within 36 months of enrollment in the study; 5. Modified DR-FLASH score \>=3 4\. Subjects must be able to provide informed consent. Exclusion Criteria: 1. History of previous catheter ablation for AF or left atrial flutter; 2. History of previous surgical ablation for AF; 3. Known intracardiac thrombus; 4. Contraindication to systemic oral anticoagulation therapy; 5. Reversible causes of AF; 6. Hypertrophic cardiomyopathy; 7. Severe valvular disease (mitral/aortic stenosis or regurgitation); 8. Subjects that are pregnant or breastfeeding; 9. Comorbid condition with life expectancy \< 1 year

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Conditions

The condition(s) this trial relates to.

atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation

Contacts and locations

Locations

  • CIUSSS de L'Estrie-CHUS-Hopital Fleurimont

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec, H2W 1T8, Canada

  • Hamilton General Hospital

    Hamilton, Ontario, Canada

  • Institute Universitaire de Cardiologie et Pneumologie du Quebec (IUCPQ)

    Québec, Quebec, G1V 4G5, Canada

  • Libin Cardiovascular Institute

    Calgary, Alberta, Canada

  • London Health Sciences Centre

    London, Ontario, Canada

  • McGill University Health Centre

    Montreal, Quebec, Canada

  • Montreal Heart Institute

    Montreal, Quebec, Canada

  • QEII Health Sciences Centre, Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H 1V7, Canada

  • Rouge Valley Regional Heart Centre

    Toronto, Ontario, Canada

  • Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 2P9, Canada

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8, Canada

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7, Canada

  • Vancouver General Hospital

    Vancouver, British Columbia, Canada

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