Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could a pacemaker plus ablation beat pills for heart failure patients with AFib?

NCT ID NCT06833138

Disease control Sponsor: French Cardiology Society 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

This study compares two approaches for people with permanent atrial fibrillation and heart failure with preserved ejection fraction. One group gets a pacemaker plus a procedure to ablate (destroy) the heart's AV node, while the other group continues with standard heart rate medications. The goal is to see if the pacemaker-ablation combo reduces deaths and heart failure hospitalizations over two years. About 266 participants will be followed with clinic visits at 3, 12, and 24 months.

What this could mean

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

Active substance
pacemaker implantation and atrioventricular node ablation
What this could lead to
If this works, it could offer a better way to manage heart failure and atrial fibrillation, potentially reducing hospital stays and improving survival.
What could go wrong
This is a mid-sized trial (266 people) and the procedure carries risks like bleeding, infection, or heart damage. It may not prove better than current medications.

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 266 people

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

Started

Sep 2025

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: * Permanent atrial fibrilation \> 6 months * Preserved Left Ventricular Ejection Fraction ≥ 50% * ≥ 1 heart failure hospitalization in the previous year * NYHA (New York Heart Association) score ≥ 2 * Presence of at least one of the following criteria related to diastolic dysfunction: * E/e' ratio \> 9 * Left Ventricular mass \> 95 g/m2 (female) or \> 115 g/m2 (male) with h/R ratio \> 0.42 * NT pro BNP (B-type Natriuretic Peptide) \> 365 pg/mL or BNP (B-type Natriuretic Peptide) \> 105 pg/mL * Narrow QRS ≤ 120 ms * Average heart rate ≤ 110/min on 24 hours Holter monitoring * Age over 18-year-old * Capacity to understand the nature of the study, legal ability and willingness to give informed consent * Patient covered by a social insurance * Effective contraception and a negative pregnancy test in women of a childbearing age Exclusion Criteria: * Patient eligible for atrial fibrilation catheter ablation * Life expectancy \< 12 months * Severe chronic kidney disease (estimated Glomerular Filtration Rate ≤ 20 ml/1,73 m2) * Severe respiratory disease (severe chronic obstructive pulmonary disease with Gold ≥ 3 and/or chronic oxygen therapy) * Class III obesity (Body Mass Index ≥ 40) * Confirmed or suspected infiltrative cardiomyopathy (amyloidosis, sarcoidosis, Fabry disease, others) * Obstructive hypertrophic cardiomyopathy * Previous implanted devices (Pacemaker / Implantable Cardioverter-Defibrillator / Cardiac Resynchronization Therapy) * Other indication for pacemaker implantation * Indication for implantable cardioverter-defibrillator * Ambulatory ≤ 50% of time * Pregnant women * Breast-feeding women

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Atrial fibrillation, persistent are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

atrial fibrillation diastolic heart failure heart failure persistent atrial fibrillation

As listed by the trial registrant

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

Atrial fibrillation, persistent Heart failure with preserved ejection fraction

How to take part

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

  1. The places running it

    17 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

  • CHRU de Caen - Hôpital Côte de Nacre

    RECRUITING

    Caen, 14000, France

  • CHRU de Nancy - Hôpitaux de Brabois

    NOT_YET_RECRUITING

    Vandœuvre-lès-Nancy, France

  • CHRU de Tours - Hôpital Trousseau

    RECRUITING

    Chambray-lès-Tours, 37170, France

  • CHU Grenoble Alpes

    NOT_YET_RECRUITING

    Grenoble, 38043, France

  • CHU de Besançon - Hôpital Jean Monjoz

    NOT_YET_RECRUITING

    Besançon, France

  • CHU de Bordeaux - Hôpital Cardiologique du Haut-Lévèque

    NOT_YET_RECRUITING

    Pessac, 33604, France

  • CHU de Clermont-Ferrand - Hôpital Gabriel Montpied

    NOT_YET_RECRUITING

    Clermont-Ferrand, France

  • CHU de Lille - Institut Cœur-Poumons

    NOT_YET_RECRUITING

    Lille, 59000, France

  • CHU de Nantes - Hôpital Nord Laennec

    NOT_YET_RECRUITING

    Nantes, 44093, France

  • CHU de Poitiers - Centre Cardiovasculaire

    RECRUITING

    Poitiers, 86021, France

  • CHU de Rennes - Hôpital Pontchallou

    NOT_YET_RECRUITING

    Rennes, France

  • CHU de Rouen - Hôpital Charles Nicolle

    RECRUITING

    Rouen, 76000, France

  • Clinique Millenaire

    RECRUITING

    Montpellier, 34000, France

  • GHICL Allome - Hôpital St Philibert

    RECRUITING

    Lomme, 59462, France

  • Groupe Hospitalier La Rochelle-Ré-Aunis

    RECRUITING

    La Rochelle, 17019, France

  • Institut Arnault Tzanck

    NOT_YET_RECRUITING

    Saint-Laurent-du-Var, France

  • Institut Montsouris

    NOT_YET_RECRUITING

    Paris, France

More trials for these conditions

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