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New strategy may cut unnecessary pacemakers after heart valve procedure

NCT ID NCT07414485

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new way to predict dangerous heart rhythm problems after a common heart valve procedure called TAVR. Researchers combined ECG results with CT scan measurements and implant depth to see if they could safely identify low-risk patients. The study looked back at 209 patients who had TAVR and were sent home without a pacemaker, tracking who later needed one within three months.

What this could mean

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

What this could lead to
If successful, this approach could help doctors safely avoid implanting unnecessary pacemakers in many patients after TAVR, reducing procedure risks and healthcare costs.
What could go wrong
This is a retrospective, observational study, not a randomized trial, so the findings may not apply to all patients. The strategy needs prospective validation before changing clinical practice.

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

209 people

The number who actually took part.

Started

Sep 2025

Finished

Apr 2026

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

The study population consisted of 209 consecutive patients underwent TAVR using contemporary transcatheter valve prostheses and were managed according to a standardized ECG-based post-procedural conduction monitoring algorithm. Only patients without pre-existing permanent pacemaker implantation and without immediate post-procedural indication for permanent pacing were included in the analysis. This population represents a clinically relevant group in whom post-discharge conduction risk stratification is particularly challenging and in whom optimization of monitoring strategies is most impactful.

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: * Any patient aged over 18 years * underwent TAVI, regardless of the access route and valve type * discharged from the hospital without a pacemaker Exclusion Criteria: * Patients with a pre-existing pacemaker prior to TAVI

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Faculté de médecine montpellier

    Montpellier, 34090, France

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Other studies related to the condition(s) this trial covers.