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Which pacemaker method works best after TAVI? new trial aims to find out

NCT ID NCT06197503

Disease control Sponsor: Hospital Clinic of Barcelona 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares two types of pacemaker settings in people who need a pacemaker after a TAVI procedure (a minimally invasive heart valve replacement). The two methods are 'physiological pacing' (which tries to mimic natural heart activation) and standard 'right ventricular pacing'. The goal is to see which method leads to better survival, heart function, and exercise ability after one year. The trial will enroll 48 participants with normal heart pumping function.

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 (left bundle branch or His bundle pacing) versus right ventricular pacing
What this could lead to
If successful, this could show that a more natural pacing method improves heart function and quality of life after TAVI better than standard pacing.
What could go wrong
This is a small, single-center trial with only 48 participants, so results may not apply to everyone. The benefit may be small or not seen at all.

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 48 people

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

Started

Nov 2023

Expected to finish

Dec 2026

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: * Successful implantation of TAVI according to VARC-3 criteria. * Indication of cardiac pacing due to AV block according to ESC Guidelines. * LVEF\> 50%. * The patient must indicate their acceptance to participate in the study by signing an informed consent document. Exclusion Criteria: * Ventricular dysfunction: LVEF \<50%. * Transapical TAVI. * Participating currently in a clinical investigation that includes an active treatment. * Patients with left bundle branch block but without indication of pacing (AV block). * Life expectancy \<12 months.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis atrioventricular block

As listed by the trial registrant

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

Av block Physiological pacing Preserved left ventricular systolic function Right ventricular pacing Transcatheter aortic valve implantation

How to take part

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

  1. The places running it

    1 site. 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

  • Hospital Clínic de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

More trials for these conditions

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