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New study tracks heart valve damage from pacemaker leads

NCT ID NCT07342036

Knowledge-focused Sponsor: Hazem Omran 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 aims to measure how often a heart valve leak (tricuspid regurgitation) develops or worsens after getting a pacemaker or defibrillator with a lead that crosses the valve. About 200 adults who need their first device will have heart ultrasounds before and after the procedure, plus checkups at 6 and 12 months. The goal is to better understand this complication and improve future care.

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 200 people

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

Started

Jul 2024

Expected to finish

Jan 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 who have been indicated to have a new cardiac device with a transvalvular probe implanted for any given indication

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: * medically indicated for pacemaker, ICD- or CRT implantation * No previous diagnosis of severe tricuspid regurgitation on enrollment * No existing transvalvular device (must be first implantation) * No other diagnosed severe valvular heart disease * Not previous diagnosis with pre-capillary pulmonary hypertension * No previous diagnosis of structural disease of the right ventricle (i.e. ACM, cardiac sarcoidosis, carcinoid...) Exclusion Criteria: * Patients unable to give consent * Under the age of 18 years * Relevant pre-capillary pulmonary hypertension according to decision of the heart-team (sPAP echo \>70 mmHg) * Severe tricuspid valve regurgitation (Grade 3 or worse) on enrollment * Patients who have undergone Lead-explantation * Exisiting valvular heart disease requiring treatment according to the decision of the heart-team. These patients may be enrolled in the study following treatment. * Previous tricuspid valve surgery * Patients with congenital heart disease (i.e. tetralogy of fallot, Ebstein's anomaly,...) * Pregnant or breastfeeding women * Life expectancy \< 12 months

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Conditions

The condition(s) this trial relates to.

heart conduction disease impulse control disorder tricuspid valve insufficiency

As listed by the trial registrant

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

ICD Left bundle branch area pacing Pacemaker Tricuspid valve 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

  • Herz- und Diabeteszentrum NRW

    RECRUITING

    Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

More trials for these conditions

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