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Pacemaker vs. pills: which works better for irregular heartbeat and heart failure?

NCT ID NCT06299514

Disease control Sponsor: Habib Khan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 02, 2026 · Updated 3 times

Summary

This study tests whether a pacemaker plus a heart ablation procedure is better than standard medications for controlling heart rate in 600 people with both atrial fibrillation and heart failure. Participants will either get a pacemaker implant and ablation, or continue with optimized heart failure drugs. The goal is to see which approach reduces deaths, heart failure events, and improves quality of life.

What this could mean

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

Active substance
Pacemaker and ablation procedure (conduction system pacing with AV node ablation) versus standard heart failure medications
What this could lead to
If successful, this could show that a pacemaker plus ablation is a better option than medication for controlling heart rate and improving quality of life in people with atrial fibrillation and heart failure.
What could go wrong
This is a large trial, but it is not yet complete. The pacemaker procedure carries risks like infection or bleeding, and it may not prove to be better than medication 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

About 600 people

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

Started

Apr 2024

Expected to finish

Dec 2029

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. Patients with permanent AF/persistent AF (in AF) 2. Patients with NYHA Class II -IVa HF symptoms 3. Guideline driven medical therapy (GDMT) for HF for at least 3 months: * for those \< 75 years of age with an NT-proBNP of ≥ 600 ng/L * for those ≥ 75 years of age with an NT-proBNP ≥ 900 ng/L, or ≥ 600 ng/L if the patient has had a HF hospitalization within 1 year Exclusion Criteria: 1. In hospital patients needing intensive care or intravenous inotropic agent in the last 4 days 2. Patients with a life expectancy of ≤ 1 year from non-cardiac cause or anticipating a transplant within 1 year 3. Acute coronary syndrome \<4 weeks or coronary revascularization \<3months 4. Unable or unwilling to provide informed consent 5. Uncorrected primary valvular disease or prosthetic tricuspid valve 6. Restrictive, hypertrophic, or irreversible form of cardiomyopathy 7. Severe pulmonary diseases requiring oxygenation 8. Patients with a known history of WHO Class I pulmonary hypertension (PH) which includes PH associated with CVD, collagen vascular disease, congenital shunts, cirrhosis and portal hypertension, HIV, hemoglobinopathies, schistosomiasis or drug-associated PH as well as those with high suspicion of irreversible pulmonary hypertension 9. Patients enrolled in competitive clinical trials that will affect the objectives of this study 10. Existing CRT/BiVP 11. Patients who are pregnant 12. Guideline indication for CRT 13. More than 20% pacing with an existing pacemaker 14. Severe mobility limitations (ex. wheelchair bound and severe neurological conditions that limit mobility)

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Conditions

The condition(s) this trial relates to.

atrial fibrillation cardiac rhythm disease heart failure

As listed by the trial registrant

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

Arrhythmia atrial Atrial fibrillation Heart failure Pacemaker

How to take part

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

  1. The places running it

    12 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

  • Centre Hospitalier de L'Université de Montréal (CHUM)

    RECRUITING

    Montreal, Quebec, H2X0A9, Canada

  • Hamilton Health Sciences Corporation

    RECRUITING

    Hamilton, Ontario, L8L2X2, Canada

  • Hôpital Fleurimont

    RECRUITING

    Sherbrooke, Quebec, J1H5N4, Canada

  • Institut universitaire de cardiologie et de pneumologie Québec - Université Laval (IUCPQ-ULaval)

    RECRUITING

    Québec, Quebec, G1V4G5, Canada

  • London Health Sciences Centre - University Hospital

    RECRUITING

    London, Ontario, N6A5A5, Canada

  • Montreal Heart Institute

    RECRUITING

    Montreal, Quebec, Canada

  • Nova Scotia Health Authority

    RECRUITING

    Halifax, Nova Scotia, B3S0H6, Canada

  • Ottawa Heart Institute Research Corporation

    RECRUITING

    Ottawa, Ontario, K1Y4W7, Canada

  • Southlake Regional Health Centre

    RECRUITING

    Newmarket, Ontario, Canada

  • Sunnybrook Health Sciences Centre

    RECRUITING

    Toronto, Ontario, Canada

  • Victoria Cardiac Arrhythmia Trials

    RECRUITING

    Victoria, British Columbia, Canada

  • Waterloo Wellington Cardiovascular Research Institute

    RECRUITING

    Kitchener, Ontario, N2G1G3, Canada

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