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Tiny implant to unmask silent heart rhythm disorder in valve patients

NCT ID NCT07377799

Knowledge-focused Sponsor: Rigshospitalet, Denmark 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will implant a small heart monitor under the skin of 100 people with moderate-to-severe mitral valve regurgitation who have few or no symptoms. The device will track heart rhythms for up to three years to find hidden atrial fibrillation that standard tests might miss. Researchers hope to learn how common these silent episodes are and whether they raise the risk of stroke or other problems.

What this could mean

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

What this could lead to
If successful, this could improve detection of hidden atrial fibrillation in mitral regurgitation patients, potentially guiding earlier treatment to prevent strokes.
What could go wrong
This is an observational study, not a treatment trial. It may not lead to direct patient benefits, and the small size (100 patients) limits how widely the findings can be applied.

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 100 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Feb 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

Patients with moderat-severe or severe primary mitral regurgitation with no or mild symptoms without a class I indication for surgical intervention

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: * Asymptomatic/mildly symptomatic\*, significant primary MR\*\* * LVEF ≥60% * Native mitral valve * Age ≥18 years old Exclusion Criteria: * Prior diagnosis of AF * Prescence of cardiac pacemaker, ICD, cardiac resynchronization device, loop recorder, or a clinical indication for loop recorder * LVESD ≥ 40 mm * Planned for mitral valve surgery * Life expectancy \< 1 year * Pregnancy or lactating

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Conditions

The condition(s) this trial relates to.

atrial fibrillation mitral valve insufficiency

As listed by the trial registrant

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

Atrial fibrillation (AF) Mitral regurgitation

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

  • Rigshospitalet

    Copenhagen, 2100, Denmark

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