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Can heart monitors catch hidden irregular heartbeats before they strike?

NCT ID NCT07816458

Diagnosis Sponsor: Medisch Spectrum Twente 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing whether continuous heart monitoring can lower unplanned hospital visits in adults with heart failure who have never shown signs of atrial fibrillation. One group receives a small monitor implanted under the chest skin, another uses a handheld device for weekly home readings, and a third receives standard care. The trial compares these approaches to see which, if any, helps detect irregular heartbeats early enough to prevent urgent cardiac care.

What this could mean

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

Active substance
heart rhythm monitoring using an implantable loop recorder or a portable home ECG device
What this could lead to
If monitoring works, doctors could catch atrial fibrillation earlier in heart failure patients and prevent some unplanned hospital visits.
What could go wrong
The monitors may detect irregular heartbeats that never cause problems, leading to unnecessary worry or treatment. The trial may also show that extra monitoring does not reduce hospital visits compared with standard 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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 258 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jun 2029

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: * Adult patients with HF and no history of documented AF on electrocardiogram (ECG) are eligible. Exclusion Criteria: * Patients with CIED such as an implantable cardioverter defibrillator (ICD), Cardiac Resyn-chronization Therapy Defibrillator (CRT-D), or pacemaker. * Documented AF before inclusion * Admission to hospices or palliative care * Inability to communicate in Dutch or English. * Participant is under age of 18 years old * Participant is pregnant * Mental disorders that, according to the treating physician, make participation unsafe

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Conditions

The condition(s) this trial relates to.

heart failure atrial fibrillation prevention target

As listed by the trial registrant

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

Heart failure

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

  • Medisch Spectrum Twente

    Enschede, 7512 KZ, Netherlands

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