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New pacemaker strategy could cut heart failure deaths after valve surgery

NCT ID NCT07434193

Disease control Sponsor: Semmelweis University Heart and Vascular Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether a special type of pacemaker, called cardiac resynchronization therapy (CRT), can help people with heart failure who develop a heart block after having their aortic valve replaced. The trial will include 360 adults who have a new, persistent heart block and moderately reduced heart function after a successful valve procedure. The goal is to see if early use of this pacemaker reduces the chance of being hospitalized for heart failure or dying within a year.

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 360 people

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

Started

Nov 2025

Expected to finish

Jan 2033

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 over 18 years * Successful and complication-free TAVI implantation for significant aortic stenosis * Signed informed consent after detailed patient information * New-onset LBBB wider than 130 ms after TAVI, persisting at the time of planned discharge (assessed postoperatively on or after day 5)(21) * Mildly reduced left ventricular systolic function on echocardiography at the planned time of discharge (at the earliest on postoperative day 5), with EF between 35% and 55% Exclusion Criteria: * Pre-existing right bundle branch block, or prior pacemaker/ICD implantation associated with significant (\>20%) ventricular pacing * Progression of LBBB during hospitalization to a degree indicating pacemaker implantation (e.g., Mobitz II or third-degree AV block, alternating bundle branch block) before the planned discharge date * Concomitant severe valvular disease of other valves (mitral, pulmonary, or tricuspid) * Severe infection and/or septic state * TAVI-associated stroke * More than moderate paravalvular leak of the TAVI valve on postoperative echocardiography * EF \< 35% or \> 55% on echocardiography performed at the planned time of discharge * GOLD stage IV COPD * Chronic renal failure requiring regular dialysis * Concurrent participation in another clinical trial

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis congestive heart failure

As listed by the trial registrant

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

Chronic 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

    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

  • Semmelweis University, Heart and Vascular Center

    RECRUITING

    Budapest, 1122, Hungary

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