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New pacing technique may improve outcomes after heart valve procedure

NCT ID NCT07236489

Disease control Sponsor: Nantes University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a newer pacing method called left bundle branch area pacing against standard pacing in people who need a pacemaker after a TAVI procedure. About 266 participants will be enrolled to see if the new method reduces heart-related deaths, hospitalizations for heart failure, and the need for repeat surgeries. The goal is to find a better way to manage heart block without causing additional heart strain.

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

Nov 2025

Expected to finish

Nov 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: * Patients who have undergone TAVI for severe aortic valve disease within the past 3 months * Preserved left ventricular ejection fraction (LVEF ≥ 50%) * Indications for pacemaker implantation according to guidelines, including : * Third-degree atrioventricular (AV) block * Second-degree AV block Mobitz type 2 or symptomatic Mobitz type 1 * Alternating left and right bundle branch block * HV interval ≥ 70 ms during electrophysiological study * Pre-existing right bundle branch block with worsening conduction disturbances post-TAVI * Prolongation of QRS and PR intervals post-procedure justifying pacemaker implantation * Signed informed consent * Patient affiliated with the national health insurance system Exclusion Criteria: * Left ventricular ejection fraction (LVEF) \< 50% before TAVI * Contraindication to implantation of an endocardial pacemaker (vascular access issues, sepsis) * Previously implanted pacemaker * Patients under legal guardianship, curatorship, or judicial protection * Participation in another interventional therapeutic clinical trial

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Conditions

The condition(s) this trial relates to.

atrioventricular block

As listed by the trial registrant

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

Atrioventricular block Pacemaker

How to take part

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

  1. The places running it

    7 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

  • Brest University Hospital

    RECRUITING

    Brest, Finistère, 29200, France

  • Clermont Ferrand University Hospital

    NOT_YET_RECRUITING

    Clermont-Ferrand, Puy-de-Dôme, 63003, France

  • Nantes University Hospital

    RECRUITING

    Nantes, Loire-Atlantique, 44093, France

  • Poitiers University Hospital

    RECRUITING

    Poitiers, Vienne, 86021, France

  • Rennes University Hospital

    RECRUITING

    Rennes, Ille-et-Vilaine, 35033, France

  • Rouen University Hospital

    RECRUITING

    Rouen, Seine-Maritime, 76031, France

  • Tours University Hospital

    RECRUITING

    Tours, Indre-et-Loire, 37044, France

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