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Can a heart procedure cut stroke risk after valve repair? new trial aims to find out

NCT ID NCT07380932

Disease control Sponsor: Atrial Fibrillation Network 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at people with atrial fibrillation (an irregular heartbeat) who have already had a successful mitral valve repair. It compares two approaches: catheter ablation (a procedure to fix the heart's electrical signals) versus standard medical care. The goal is to see if ablation reduces major problems like stroke, heart failure, or death. About 956 participants will be randomly assigned to one of the two groups and followed over time.

What this could mean

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

Active substance
catheter ablation
What this could lead to
If successful, this could show that catheter ablation reduces the risk of heart failure, stroke, and death in patients with atrial fibrillation after mitral valve repair.
What could go wrong
This trial has not started recruiting yet, and it is an early-stage strategy comparison. The procedure carries risks like bleeding, infection, or heart rhythm problems, and may not prove superior to 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

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 956 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jan 2032

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: * Patients with documented atrial fibrillation (AF). * Transcatheter edge-to-edge mitral-valve repair (TEER) for severe functional mitral valve regurgitation (MR) with successful result (less than moderate MR, gradient \< 5 mmHg) performed within a period of minimum of 30 days and a maximum of 6 months. Moderate residual MR is eligible if no further mitral valve intervention or surgery is planned and patient is stable for \> 3 months. * Provision of signed informed consent. Exclusion Criteria: * Age \<18 years * Patient not suitable for AF ablation * Previous ablation procedure for AF * Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 2 months prior to enrolment * Untreated hypothyroidism or hyperthyroidism requiring therapy * Enrolment in another randomised study * Indication for cardiac resynchronization therapy * Current pregnancy, breastfeeding, or women not using reliable contraceptive measures during fertility age * Mental or physical inability to participate in the study * Planned cardiovascular intervention or operation * Life expectancy ≤ 12 month

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Conditions

The condition(s) this trial relates to.

atrial fibrillation gastroesophageal reflux disease mitral valve insufficiency

As listed by the trial registrant

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

Atrial fibrillation (AF) Mitral valve (MV) regurgitation

How to take part

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

  1. The places running it

    4 sites. 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

  • Asklepios Hospital St. Georg

    Hamburg, Germany

  • University Heart and Vascular Center Frankfurt

    Frankfurt, Germany

  • University Hospital Cologne

    Cologne, Germany

  • University Hospital Münster

    Münster, 48149, Germany

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