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New heart scanner could improve pacemaker decisions

NCT ID NCT06641362

Diagnosis Sponsor: VDI Technologies 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new type of electrocardiogram (UHF-ECG) that uses ultra-high frequency waves to detect when the heart's lower chambers are not beating in sync. Researchers will compare it to the standard 12-lead ECG in 360 adults with slow heart rate or heart failure who are scheduled to get a pacemaker. The goal is to see if the new device is safer and more accurate at diagnosing this coordination problem, which could help doctors choose the right pacemaker settings.

What this could mean

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

Active substance
Ultra-High Frequency Electrocardiogram (UHF-ECG) device
What this could lead to
If successful, this could provide a more accurate way to diagnose heart coordination problems, helping doctors decide on the best pacemaker treatment.
What could go wrong
This is an early-stage device study with 360 participants, so results may not apply to everyone. The new ECG may not be significantly better than the standard one.

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 360 people

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

Started

Mar 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants who are eligible for this study must have bradycardia or heart failure and are scheduled for pacemaker device implantation. Baseline ECG requirements must be met.

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: * Adults with bradycardia or heart failure scheduled for first time pacemaker implant (including CRT/CSP) with one of the following: Bradycardia with ventricular synchrony and QRS duration \<= 110 ms, Bradycardia with LBBB, Bradycardia with RBBB, Bradycardia with other IVCD necessitating intervention, or Heart failure with LBBB * Understands the nature of the study and is willing to comply with all study requirements. * Provides written informed consent. * A negative pregnancy test prior to the procedure for participants of child-bearing potential. Exclusion Criteria: * Complete AV block (3rd-degree AV block) without a stable escape rhythm or other circumstances where there is no measurable QRS. * Subjects with a previous or current pacemaker or defibrillator implant. * Anatomical or other conditions that may make a 12-lead ECG difficult to obtain, such as an allergy to components of the ECG pads, burns, open wounds, etc. * Currently enrolled in another investigational device or drug trial that has not completed the active treatment phase and/or would conflict with this study. * Other co-morbid condition(s) that could limit the participant's ability to participate in the study or to comply with study requirements or impact the scientific integrity of the study.

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Conditions

The condition(s) this trial relates to.

Bradycardia cardiac ventricle disorder heart failure Ventricular Dysfunction

As listed by the trial registrant

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

Bradycardia Heart failure Ventricular dysfunction

How to take part

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

  1. The places running it

    12 sites in 3 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

  • Banner Medical Center

    RECRUITING

    Mesa, Arizona, 85202, United States

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Catherina Ziekenhuis

    RECRUITING

    Eindhoven, 5623, Netherlands

  • Fakultni Nemocnice Královské Vinohrady

    RECRUITING

    Prague, Czechia

  • Fakultní nemocnice Brno

    RECRUITING

    Brno, 625 00, Czechia

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Na Homolce Hospital

    RECRUITING

    Prague, 150 30, Czechia

  • Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Peak Heart and Vascular

    RECRUITING

    Avondale, Arizona, 85392, United States

  • St. Anne's University Hospital

    RECRUITING

    Brno, 65691, Czechia

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22908, United States

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