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New pacemaker approach could improve life for heart failure patients with AFib

NCT ID NCT07604727

Disease control Sponsor: University Medical Center Groningen 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two types of pacemaker procedures in adults with heart failure and atrial fibrillation who are not candidates for rhythm control. All participants will receive a heart ablation, then be randomly assigned to either conduction system pacing or standard cardiac resynchronization therapy. Researchers will track deaths, heart failure hospitalizations, and quality of life over three years to see if the newer pacing method is at least as good as the standard one.

What this could mean

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

Active substance
Conduction system pacing or cardiac resynchronization therapy (both are procedures to implant a pacemaker)
What this could lead to
If it works, this could show that conduction system pacing is a better option than standard cardiac resynchronization for managing heart failure symptoms and improving quality of life in people with atrial fibrillation.
What could go wrong
This trial has not started recruiting yet, so results are years away. It is also a noninferiority study, meaning it aims to show one method is not worse than the other, not necessarily that it is better. Risks include complications from the ablation or pacemaker implantation.

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 292 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jun 2030

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: * Age 18 years or above. * Patient is diagnosed with AF and deemed not amenable to rhythm control. This diagnosis of AF will be demonstrated by at least one Electrocardiograph (ECG) showing AF that was performed within one year prior to enrollment. * Has history of stable heart failure (regardless left ventricular ejection fraction) and has a history of at least one HF related hospitalization or emergency room/urgent care visit within 2 years prior to enrollment, despite being on maximally tolerable guideline directed medical therapy. * Willing and capable to provide informed consent. Exclusion Criteria: * NYHA functional class IV. * Severe concomitant non-cardiac disease. * Patient who require any cardiac surgical intervention. * Previously implanted pacing devices (pacemaker/ICD/CRT) with ≥40% pacing burden. * Any of the following within the 3 months prior to enrollment: * Myocardial infarction * Unstable angina * Percutaneous coronary intervention * Stroke or TIA * Significant bleeding * Pericarditis/effusions * Coronary artery bypass surgery/atriotomy within 6 months prior to enrolment. * Women who are pregnant or breastfeeding.

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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 (AF) Cardiac pacing Heart failure

How to take part

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

  1. The places running it

    23 sites in 4 countries. 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

  • Antonius Hospital

    Nieuwegein, Netherlands

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, Italy

  • CHU de Grenoble

    Grenoble, France

  • CHU de Rouen

    Rouen, France

  • CHU la Timone

    Marseille, France

  • Clinique Pasteur Toulouse

    Toulouse, France

  • Department of Cardiology, IRCCS Instituto Auxologico Italiano, Ospedale San Luca

    Milan, Italy

  • Department of Cardiology, Ospedale Panico

    Tricase, Italy

  • Department of Cardiology, Ospedale S. Maria Nuova

    Reggio Emilia, Italy

  • Department of Cardiology, Ospedali del Tigullio

    Lavagna, Italy

  • FrisiusMC

    Leeuwarden, Netherlands

  • Hôpital Européen Georges Pompidou

    Paris, France

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, Netherlands

  • Klinik für Kardiologie und Intensivmedizin

    Stade, Germany

  • Klinikum rechts der Isar

    München, Germany

  • Maastricht UMC

    Maastricht, Netherlands

  • Marienhospital Gelsenkirchen

    Gelsenkirchen, Germany

  • Ospedale San Pietro Fatebenefratelli

    Roma, Italy

  • Ospedale San Raffaele

    Milan, Italy

  • Ospedale Santa Maria della Pieta

    Nola, Italy

  • St. Vincenz-Krankenhaus GmbH

    Paderborn, Germany

  • University Medical Center Groningen

    Groningen, Provincie Groningen, Netherlands

  • University Medical Center Mainz

    Mainz, Germany

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