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Pacemaker showdown: which device spares the Heart's valve?

NCT ID NCT07793916

Knowledge-focused Sponsor: Samsung Medical 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This observational study follows 1000 adults with cardiac implantable electronic devices, such as pacemakers and defibrillators, to see how these devices affect tricuspid regurgitation, a condition where the heart's tricuspid valve leaks. Researchers will use 3D echocardiography to compare newer pacing methods, like left bundle branch area pacing and leadless pacemakers, against conventional pacemakers. The goal is to identify which device type is least likely to worsen valve leakage and lead to heart failure hospitalizations.

What this could mean

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

Active substance
3D transthoracic echocardiography (diagnostic imaging test)
What this could lead to
If this study succeeds, it could identify which pacemaker type is least likely to worsen tricuspid regurgitation, guiding device choice and reducing heart failure hospitalizations.
What could go wrong
This is an observational study, so it cannot prove cause and effect. The results may be influenced by patient differences, and the findings might not apply to all CIED patients.

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 1,000 people

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

Started

Jan 2026

Expected to finish

Jan 2028

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

Subjects aged 19 years or older who underwent de novo implantation of a leadless PPM or a cardiac implantable electronic device (PPM or ICD) with trans-tricuspid leads at Samsung Medical Center between 2022 and 2025, and are at least one year post-implantation

Ages

19 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: * Aged 19 years or older. * Patients who are at least one year post-implantation of one of the following Cardiac Implantable Electronic Devices (CIEDs): A. Permanent Pacemaker (PPM) B. Implantable Cardioverter-Defibrillator (ICD) C. Leadless Pacemaker * Patients who underwent the implantation procedure on or after January 2022. * Voluntary informed consent provided by the patient or their legal representative for the review of medical records and study-related data throughout the entire study period. Exclusion Criteria: * Patients with lead-based CIEDs whose leads do not cross the tricuspid annulus or those with two or more leads crossing the annulus. * Patients whose baseline degree of tricuspid regurgitation (TR) cannot be assessed due to the absence of transthoracic echocardiography (TTE) performed within three months of the procedure. * Patients with a history of ventricular lead extraction. * Patients who have undergone tricuspid valve replacement surgery. * Individuals who refuse active medical treatment.

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Conditions

The condition(s) this trial relates to.

tricuspid valve insufficiency

As listed by the trial registrant

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

Cied implantation Leadless pacemaker Pacemaker Tricuspid regurgitation

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

  • Samsung Medical Center

    RECRUITING

    Seoul, Seoul, 06351, South Korea

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