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Pacemaker study aims to predict and prevent heart weakening

NCT ID NCT07276139

Knowledge-focused Sponsor: Insel Gruppe AG, University Hospital Bern 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 1 time

Summary

This study is observing 4,500 people who need pacemakers or similar heart devices. The goal is to create a tool that predicts who is at risk of developing a weakened heart from the device itself. By identifying high-risk patients early, doctors can choose better pacing methods to prevent complications.

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 4,500 people

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

Started

Jan 2026

Expected to finish

Jan 2031

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

The study population includes adults undergoing a cardiac implantable electronic device (CIED) procedure for standard clinical indications, included in two arms. In the prospective arm, consecutive patients at a participating center are enrolled at the time of the procedure. In the retrospective arm, centers include all consecutive patients who underwent a CIED procedure from a center-specific start date up to the date of data extraction, using data already recorded during clinical care. Participants are drawn from centers in Switzerland, Germany, Poland, Croatia, Bulgaria, Cyprus, and Australia, with planned activation of sites in the UK. The population includes patients receiving pacemakers, ICDs, or CRT devices; patients with existing CRT at baseline serve as a comparator. Both arms use the same case report form and the same endpoint definitions. Enrollment reflects diverse healthcare settings and demographics.

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 ≥18 years at the time of the CIED procedure * Undergoing, or having undergone, a CIED procedure (permanent pacemaker, ICD, or CRT) * A lawful basis for inclusion: signed informed consent prior to enrollment in the prospective arm, or a lawful basis for the further use of health-related personal data in the retrospective arm * Prospective arm only: willing and able to participate in long-term follow-up * Prospective arm only: sufficient language comprehension (or support) to provide informed consent and complete PROMs/PREMs Exclusion Criteria: * Prospective arm only: severe cognitive impairment without a legal representative * A documented objection to the use of health-related data for research

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac cardiac rhythm disease cardiomyopathy conduction system disorder extrinsic cardiomyopathy heart failure ventricular arrhythmias due to cardiac ryanodine receptor calcium release deficiency syndrome

As listed by the trial registrant

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

Arrhythmias, cardiac Cardiomyopathy, secondary Conduction system pacing Heart failure Pacing-induced cardiomyopathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites in 7 countries. 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

  • 4th Military Clinical Hospital

    NOT_YET_RECRUITING

    Wroclaw, Poland

  • Acibadem City Clinic Tokuda Hospital

    NOT_YET_RECRUITING

    Sofia, Bulgaria

  • Canberra Health Services

    RECRUITING

    Canberra, Australian Capital Territory, Australia

  • Clinical Provincial Hospital No. 2

    NOT_YET_RECRUITING

    Rzeszów, Poland

  • Dubrava University Hospital

    NOT_YET_RECRUITING

    Zagreb, Croatia

  • Hôpitaux Universitaires de Genève

    NOT_YET_RECRUITING

    Geneva, Switzerland

  • Inselspital, University Hospital Bern

    RECRUITING

    Bern, 3010, Switzerland

  • Kantonsspital Baden

    NOT_YET_RECRUITING

    Baden, Switzerland

  • Medical University of Silesia

    NOT_YET_RECRUITING

    Zabrze, Poland

  • National Institute of Cardiology

    NOT_YET_RECRUITING

    Warsaw, Poland

  • Nicosia General Hospital

    NOT_YET_RECRUITING

    Nicosia, Cyprus

  • University Heart Center Freiburg-Bad Krozingen

    NOT_YET_RECRUITING

    Bad Krozingen, Germany

  • University Hospital Tsaritsa Yoanna ISUL

    NOT_YET_RECRUITING

    Sofia, Bulgaria

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