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Heart procedure may beat drugs for AFib patients with heart failure

NCT ID NCT01420393

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether catheter ablation (a procedure to fix irregular heart rhythm) is better than standard rate-control medication for people with both atrial fibrillation and heart failure. Over 400 participants were randomly assigned to either ablation or medication. The main goal was to see which approach reduces deaths and heart failure-related hospital visits. The results could change how doctors treat these two common heart conditions together.

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 to destroy small areas of heart tissue causing irregular rhythm)
What this could lead to
If successful, this could show that catheter ablation is better than standard medication at reducing deaths and hospital stays for people with both atrial fibrillation and heart failure.
What could go wrong
This is a completed study, but results may not apply to all patients. Catheter ablation carries risks like bleeding, infection, or heart damage, and it may not work for everyone.

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

411 people

The number who actually took part.

Start date

Sep 2011

Finished

Jun 2021

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. Patients with one of the following AF categories and at least one ECG documentation of AF * High burden Paroxysmal defined as ≥ 4 episodes of AF in the last 6 months, and at least one episode \> 6 hours (and no episode requiring cardioversion and no episode \> 7 days) * Persistent AF (1) defined as ≥ 4 episodes of AF in the last 6 months, and at least one episode \> 6 hours, and at least one AF episode less than 7 days but requires cardioversion. No AF episodes are \> 7 days * Persistent AF (2) as defined by at least one episode of AF \> 7 days but not \> 1 year * Long term persistent AF defined as an AF episode, at least one year in length and no episodes \> 3 years 2. Optimal therapy for heart failure of at least 6 weeks (according to 2009 ACCF/AHA class 1 recommendations). 3. HF with NYHA class II or III symptoms with either impaired LV function (LVEF ≤ 45%) as determined by EF assessment within the previous 12 months or preserved LV function (LVEF \> 45%) determined by by EF assessment within the previous 12 months 4. NT-pro BNP measures: A) Patient has been hospitalized for Heart Failure\* in the past 9 months, has been discharged AND: i- Is presently in Normal Sinus Rhythm and NT-pro BNP is ≥ 400 pg/mL ii- Is presently in Atrial Fibrillation and NT-pro BNP is ≥ 600 pg/mL OR B) Patient has had no hospitalization for Heart Failure in the past 9 months AND: i- Has had paroxysmal Atrial Fibrillation, is presently in Normal Sinus Rhythm and NT-proBNP is ≥ 600 pg/mL ii- Is presently in Atrial Fibrillation and NT-proBNP is ≥ 900 pg/mL \*Heart Failure Admission is defined as admission to hospital \> 24 hours and received treatment for Heart failure 5. Suitable candidate for catheter ablation or rate control therapy for the treatment of AF 6. Age ≥18 Exclusion Criteria: 1. Have an LA dimension \> 55 mm as determined by an echocardiography within the previous year 2. Had an acute coronary syndrome or coronary artery bypass surgery within 12 weeks 3. Have rheumatic heart disease, severe aortic or mitral valvular heart disease using the AHA/ACC guidelines 4. Have congenital heart disease including previous ASD repair, persistent left superior vena cava 5. Had prior surgical or percutaneous AF ablation procedure or atrioventricular nodal (AVN) ablation 6. Have a medical condition likely to limit survival to \< 1 year 7. Have New York Heart Association (NYHA) class IV heart failure symptoms 8. Have contraindication to systematic anticoagulation 9. Have renal failure requiring dialysis 10. AF due to reversible cause e.g. hyperthyroid state 11. Are pregnant 12. Are included in other clinical trials that will affect the objectives of this study 13. Have a history of non-compliance to medical therapy 14. Are unable or unwilling to provide informed consent

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Conditions

The condition(s) this trial relates to.

atrial fibrillation heart failure

As listed by the trial registrant

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

Atrial fibrillation Heart failure

Contacts and locations

Locations

  • CHUM Centre hospitalier universitaire de Montréal

    Montreal, Quebec, H2L 4M1, Canada

  • CHUS Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Hamilton Health Sciences Centre

    Hamilton, Ontario, L8L 2X2, Canada

  • Insitut universitaire de cardiologie and pneumologie de Quebec

    Québec, Quebec, G1V 4G5, Canada

  • Institute de Cardiologie de Montréal

    Montreal, Quebec, H1T 1C8, Canada

  • Instituto de Cardiologia-FUC RS

    Porto Alegre, Rio Grande do Sul, 90620-001, Brazil

  • Karolinska University Hospital

    Stockholm, S-171 76, Sweden

  • Kingston General Hospital

    Kingston, Ontario, K7L 2V7, Canada

  • Libin Cardiovascular Institute of Alberta, Calgary

    Calgary, Alberta, T2N 2T9, Canada

  • London Health Sciences Centre

    London, Ontario, N6A 5A5, Canada

  • McGill University Health Centre

    Montreal, Quebec, H3A 1A1, Canada

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • Queen Elizabeth II Health Science

    Halifax, Nova Scotia, B3H 3A7, Canada

  • Royal Alexandra Hospital

    Edmonton, Alberta, T5H 3V9, Canada

  • Royal Jubilee Hospital

    Victoria, British Columbia, V8R 4R2, Canada

  • Southlake Regional Health Care

    Newmarket, Ontario, L3Y 8C3, Canada

  • St. Mary's General Hospital

    Kitchener, Ontario, N2M 1B2, Canada

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5, Canada

  • Toronto General Hospital, University Health Network

    Toronto, Ontario, M5G 2M9, Canada

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7, Canada

  • Vancouver General

    Vancouver, British Columbia, V6Z 1Y6, Canada

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