New heart study aims to cut unnecessary pacemaker implants by half

NCT ID NCT04225520

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether using an ultrasound measure of heart muscle coordination (mechanical dyssynchrony) can better select heart failure patients for cardiac resynchronization therapy (CRT) than current guidelines. About 500 patients will receive a CRT device, but pacing will be turned on or off based on their dyssynchrony status in the experimental group. The goal is to see if this approach reduces the number of people who get a device without benefit, while maintaining good outcomes.

What this could mean

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

Active substance
Cardiac resynchronization therapy (CRT) device implantation with bi-ventricular pacing turned on or off
What this could lead to
If successful, this could lead to a more precise way to select heart failure patients for CRT, reducing unnecessary implants and improving outcomes.
What could go wrong
This is an observational study comparing two selection methods, not testing a new treatment. The benefit depends on whether mechanical dyssynchrony reliably predicts response, which may not hold in all patients.

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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

  • AZ Damiaan

    Ostend, 8400, Belgium

  • AZ Delta

    Roeselare, 8800, Belgium

  • AZ Maria Middelares

    Ghent, 9000, Belgium

  • AZ Sint-Jan Brugge

    Bruges, 8000, Belgium

  • CHRU Brest

    Brest, 29200, France

  • CHU Rennes - Pontchaillou Hospital

    Rennes, 35000, France

  • CHU de São João

    Porto, 4200-319, Portugal

  • Dante Pazzanese Institute of Cardiology

    São Paulo, 04012-909, Brazil

  • Ghent University Hospital

    Ghent, 9000, Belgium

  • Groupements des hôpitaux de l'institut catholique de Lille

    Lille, 59800 Lille, France

  • Heart Institute Nicolae Stancioiu

    Cluj-Napoca, 400001, Romania

  • Hospital Clínico de Barcelona

    Barcelona, 08036, Spain

  • Klinika Wad Wrodzonych Serca

    Warsaw, 04-628, Poland

  • Paul Stradins Clinical University hospital

    Riga, LV-1002, Latvia

  • Poznan University of Medical Sciences

    Poznan, 61-701, Poland

  • Semmelweis University Heart Center

    Budapest, 1122, Hungary

  • Silesian Center for Heart Diseases

    Zabrze, 41-800, Poland

  • St. Vinzenz-Hospital

    Cologne, 50733, Germany

  • UZ Leuven

    Leuven, 3000, Belgium

  • University Hospital Antwerp

    Antwerp, 2000, Belgium

  • Universitätsklinikum Würzburg

    Würzburg, 97080, Germany

  • Universitätsmedizin Rostock

    Rostock, 18057, Germany

  • Universitätsspital Zürich

    Zurich, 8091, Switzerland

  • ZNA Middelheim

    Antwerp, 2020, Belgium

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