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New heart study aims to cut unnecessary pacemaker implants by half

NCT ID NCT04225520

Knowledge-focused Sponsor: Universitaire Ziekenhuizen KU Leuven Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 500 people

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

Started

Dec 2020

Expected to finish

Dec 2030

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.

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 - - - - - - - - -) The proposed inclusion criteria represent the minimum recommendations for CRT implantation in heart failure patients according to the ESC 2021 guidelines. In addition: * Patient has a LVEF ≤ 35% * Patient has a LVEDD ≥ 2.7cm/m² or LVEDD ≥ 50mm (m) and ≥45mm (f) * Patient has been in a stable medical condition for ≥ 1 month prior inclusion * Patient underwent complete revascularization in case of ischemia * Patients is able to understand and willing to provide a written informed consent * Patient is 18 years or older (- - - - - - - - - Exclusion Criteria - - - - - - - - -) Patients with the following conditions will be excluded: * unreliable left ventricular volume measurements * severe MR or more than moderate other valvular disease * pulmonary hypertension, other than secondary to left heart disease * patient on hemodialysis * life expectancy \< 1 year * pregnant or breastfeeding Patients with prior right ventricular pacing between 20% to 80% will be excluded. Patients with prior right ventricular pacing ≤ 20% or no pacemaker / ICD will be excluded if they have any of the following criteria: * PR duration \> 250ms * second / third degree atrioventricular block * intrinsic QRS duration \< 130ms * atrial fibrillation with resting HR \< 50/min or \> 80/min Patients with prior right ventricular pacing ≥ 80% will be excluded if they have any of the following criteria: * sensed AV delay \> 250ms * paced AV delay \> 280ms Patients with a prior pacemaker / ICD scheduled for LBBaP will be excluded regardless of pacing percentage

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Conditions

The condition(s) this trial relates to.

dilated cardiomyopathy heart failure Ventricular Remodeling

As listed by the trial registrant

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

Cardiac remodeling, ventricular Cardiomyopathy, dilated Heart failure Left ventricular dyssynchrony

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

More trials for these conditions

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