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New study aims to cut unnecessary pacemakers after heart valve procedure

NCT ID NCT04139616

Disease control Sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study tests a pre-set treatment plan for managing heart rhythm issues that can occur after transcatheter aortic valve replacement (TAVR). The goal is to reduce the number of patients who receive a permanent pacemaker while ensuring no one is put at risk of sudden cardiac death. Researchers will follow 2,000 patients to see if the standardized approach works better than current varied practices.

What this could mean

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

Active substance
pre-specified treatment algorithm for managing conduction disturbances
What this could lead to
If successful, this could establish a standard care pathway that reduces the need for permanent pacemakers after TAVR without increasing the risk of dangerous heart rhythm events.
What could go wrong
This is an observational study testing a management strategy, not a new drug or device. Results depend on how well hospitals follow the algorithm, and individual patient factors may still require pacemakers.

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.

Participants

About 2,000 people

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

Started

Feb 2020

Expected to finish

Dec 2027

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.

Who is studied

Patients with aortic valve disease undergoing transcatheter aortic valve replacement without prior permanent pacemaker

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 with aortic valve disease undergoing transcatheter aortic valve replacement Exclusion Criteria: * Prior permanent pacemaker * Failure to provide signed informed consent for data collection * Impossibility for a follow-up * Unwillingness to follow the pre-specified strategy for the management of conduction disturbances

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Conditions

The condition(s) this trial relates to.

aortic valve disorder atrioventricular block cardiac conduction defect progressive familial heart block, type 1A

As listed by the trial registrant

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

Conduction disturbances Permanent pacemaker implantation Transcatheter aortic valve replacement

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

  • IUCPQ

    RECRUITING

    Québec, Quebec, G1V 4G5, Canada

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