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Can a One-Two punch fix a leaky heart valve and restore normal rhythm?

NCT ID NCT07741383

Disease control Sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This trial tests whether combining a minimally invasive heart valve repair (TEER) with an electrical shock to restore normal heart rhythm (cardioversion) can improve outcomes for people with severe mitral regurgitation and atrial fibrillation. Participants who have already had a successful TEER will be randomly assigned to also receive cardioversion during the same procedure or to receive standard care alone. The study will track whether the combined approach reduces the chance of death, heart failure hospitalizations, or stroke within a year.

What this could mean

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

Active substance
Transcatheter Edge-to-Edge Repair (TEER) followed by immediate electrical cardioversion (ECV) during the same procedure
What this could lead to
If successful, this combined approach could reduce the risk of death, heart failure hospitalizations, and stroke in people with severe mitral regurgitation and atrial fibrillation, offering a more effective one-time strategy.
What could go wrong
This is an early-stage trial, and the combined procedure carries risks such as bleeding, infection, or complications from the shock. The results may not apply to all patients, and the benefit over standard care is not yet proven.

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 570 people

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

Started

Jul 2026

Expected to finish

Dec 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: 1. Age ≥ 18 years; 2. Successful TEER procedure with residual mitral regurgitation grade \< 2+; 3. No left atrial thrombus, no severe cardiomyopathy, left atrial anteroposterior diameter \< 5.5 cm, and anatomically suitable for electrical cardioversion; 4. Ability to understand the study objectives, voluntarily sign the informed consent form, and willingness to comply with required examinations and clinical follow-up. Exclusion Criteria: * 1\. Left ventricular ejection fraction \< 20%; 2. Stroke or transient ischemic attack within 30 days; 3. Contraindication to anticoagulants, antiplatelet agents, or antiarrhythmic drugs; 4. Severe diseases that may interfere with treatment evaluation, such as severe neurological impairment affecting cognitive function, malignant tumors, etc.; 5. Life expectancy \< 12 months; 6. Any other anatomical, concomitant disease, medical, social, or psychological condition that, in the investigator's judgment, may limit the participant's ability to comply with study requirements or affect the scientific validity of the study results.

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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 mitral valve insufficiency

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

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310009, China

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