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Could a pacemaker boost exercise capacity in adults with a rare heart condition?

NCT ID NCT05524324

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This trial investigates whether cardiac resynchronization therapy (CRT) — a special type of pacing — can improve how far people can walk in six minutes. It includes adults with congenital heart disease where the right ventricle pumps blood to the body (systemic right ventricle). Participants already have a CRT device implanted and will be randomly assigned to have it active or inactive for three months, then switch. The study measures exercise capacity, oxygen use, and heart function.

What this could mean

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

Active substance
cardiac resynchronization therapy (biventricular pacing device)
What this could lead to
If it works, this could show that CRT improves daily function and heart efficiency in adults with this specific heart condition.
What could go wrong
This is a small crossover trial with 26 participants, so results may not apply broadly. The device may not improve symptoms for everyone, and there are standard risks of pacing therapy.

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

26 people

The number who actually took part.

Started

Nov 2022

Finished

Apr 2026

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: * systemic right ventricle (SRV), * CRT-P or CRT-D device implanted for at least 1 month, * Age ≥18 years old, * One of the two following CRT indications: * NYHA II-IV, right ventricular ejection fraction ≤ 35% and spontaneous QRS duration ≥ 150 ms Or * NYHAI-IV, atrioventricular conduction disorders with ventricular pacing \> 40% (regardless right ventricular ejection fraction). * Affiliation to a french social security system (beneficiary or legal) * Informed and signed consent Exclusion Criteria: * Pregnancy or breastfeeding * Women of childbearing potential who do not have a negative pregnancy test and do not use one of the following methods of birth control: hormonal contraception or intrauterine device or bilateral tubal occlusion * Patient benefiting from a measure of legal protection (guardianship, curatorship, under judicial safeguard, activated future protection mandate and family authorization), * Cardiac surgery during the last 3 months or planned during the next 6 months, * Percutaneous structural cardiac intervention planned during the next 6 months, * Persistent atrial arrhythmia with catheter ablation planned during the next 6 months, * Acute congestive heart failure, * Dysfunction of at least one CRT device lead that compromise biventricular pacing, * Patient on AME * Current participation in another interventional clinical study or being in the exclusion period at the end of a previous study.

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Conditions

The condition(s) this trial relates to.

congenital heart disease congenitally corrected transposition of the great arteries heart failure transposition of the great arteries

As listed by the trial registrant

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

Congenital heart disease Congenitally corrected transposition of the great arteries Heart failure congenital Systemic right ventricle Transposition of great vessels

Contacts and locations

Locations

  • AP-HP, Pitié-Salpétrière

    Paris, France

  • Ap-Hp Hegp

    Paris, 75015, France

  • CHU de Caen

    Caen, France

  • CHU de Lille

    Lille, France

  • CHU de Montpellier

    Montpellier, France

  • CHU de Nantes

    Nantes, France

  • CHU de Rouen

    Rouen, France

  • CHU de Toulouse

    Toulouse, France

  • CHU de Tours

    Tours, France

  • Clinique Pasteur

    Toulouse, France

  • Hôpital La Timone

    Marseille, France

  • Hôpital Louis Pradel

    Lyon, France

  • Hôpital Marie-Lannelongue

    Le Plessis-Robinson, France

More trials for these conditions

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