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Can a Dual-Chamber device shrink an enlarged heart in AF patients?

NCT ID NCT01994252

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at 200 people with both heart failure and permanent atrial fibrillation. Participants received either a standard defibrillator (ICD) or one that also paces both lower heart chambers (CRT/ICD). The goal was to see if the extra pacing reduces heart size and improves pumping function, quality of life, and survival. The trial is now complete, and results will show whether this approach helps this specific group.

What this could mean

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

Active substance
Implantable cardioverter-defibrillator (ICD) with or without cardiac resynchronization therapy (CRT)
What this could lead to
If successful, this could show that biventricular pacing helps shrink an enlarged heart and improve pumping efficiency in heart failure patients with permanent atrial fibrillation.
What could go wrong
This is a completed trial with 200 participants, so results are available but may not apply to all patients. The benefit of CRT in atrial fibrillation is still debated, and device implantation carries risks like infection or lead problems.

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 200 people

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

Started

Jun 2014

Finished

May 2025

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: * Patients with NYHA Class II or III HF symptoms (assessment in the last 3 months) * Permanent AF * Optimal Medical Therapy for HF of at least 3 months (according to 2009 ACCF/AHA and ESC 2012 recommendations,) * LVEF ≤ 35% (assessment in the last 6 months) * Candidacy for an ICD for primary or secondary prevention of sudden cardiac death * QRS durations ≥ 130 ms when the QRS morphology is LBBB, or QRS durations ≥ 150 ms when the QRS morphology is non-LBBB or Paced QRS Exclusion Criteria: * In-hospital patients who have acute cardiac or non-cardiac illness that requires intensive care * Intra-venous inotropic agent in the last 4 days * Patients with a life expectancy of less than one year from non-cardiac cause. * Expected to undergo cardiac transplantation within one year (status I) * Acute coronary syndrome (including MI) \< 4 weeks * Unable or unwilling to provide informed consent * Uncorrected or uncorrectable primary valvular disease * Restrictive, hypertrophic or reversible form of cardiomyopathy * Severe primary pulmonary disease such as cor pulmonale * Tricuspid prosthetic valve * Patients included in other clinical trial that will affect the objectives of this study * Coronary revascularization (CABG or PCI) \< 3 months * Patients with an existing ICD or CRT pacemaker

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Conditions

The condition(s) this trial relates to.

atrial fibrillation congestive heart failure heart disorder heart failure

As listed by the trial registrant

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

Atrial fibrillation Congestive heart failure Heart disease

Contacts and locations

Locations

  • CHUM Centre hospitalier universitaire de Montréal

    Montreal, Quebec, Canada

  • Hamilton Health Sciences

    Hamilton, Ontario, Canada

  • Institut universitaire de cardiologie et de pneumologie de Quebec

    Québec, Quebec, Canada

  • Kingston General Hospital

    Kingston, Ontario, Canada

  • Le Centre hospitalier universitaire de Sherbrooke

    Sherbrooke, Quebec, Canada

  • Libin Cardiovascular Institute of Alberta

    Calgary, Alberta, Canada

  • London Health Sciences Centre

    London, Ontario, N6A 5A5, Canada

  • McGill Health Science Centre

    Montreal, Quebec, Canada

  • Montreal Heart Institute

    Montreal, Quebec, Canada

  • Queen Elizabeth II Health Science

    Halifax, Nova Scotia, Canada

  • St. Boniface General Hospital

    Winnipeg, Manitoba, Canada

  • St. Michael's General Hospital

    Toronto, Ontario, Canada

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1W 4W7, Canada

  • Vancouver General Hospital

    Vancouver, British Columbia, Canada

  • Victoria Cardiac Arrhythmia Trials

    Victoria, British Columbia, V8R 4R2, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.