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Heart procedure may fix leaky valves in AF patients, new trial aims to prove it

NCT ID NCT06883864

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether a catheter ablation procedure can reduce severe mitral valve leakage in people with persistent atrial fibrillation (a type of irregular heartbeat). About 146 adults aged 18-80 with both conditions will either get the ablation plus standard care or just standard care. The main goal is to see if the valve leakage improves after 3 months.

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 146 people

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

Started

Apr 2025

Expected to finish

May 2028

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 to 80 years

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. Patients were required to have moderate-to-severe or greater (≥3+) atrial functional mitral regurgitation assessed by transthoracic echocardiography within 14 days before randomization. Mitral regurgitation severity was graded by an echocardiography core-lab based on the American Society of Echocardiography criteria, specifically an effective regurgitant orifice area (EROA) ≥30 mm² 2. Age 18-80 years 3. Persistent atrial fibrillation diagnosed by electrocardiogram 4. Left ventricular ejection fraction ≥50% assessed by transthoracic echocardiography within 14 days before randomization(confirmed by the echocardiography core-lab) 5. Left ventricular end-diastolic internal diameter ≤60 mm and left atrial anterior- posterior diameter ≤60 mm in echocardiographic parasternal long-axis view within 14 days before randomization(confirmed by the echocardiography core-lab) 6. Agree to undergo catheter ablation and be able to undergo follow-up as required. Exclusion Criteria: 1. paroxysmal atrial fibrillation, atrial fibrillation secondary to an apparently reversible cause, or with history of previous ablation; 2. primary mitral valve pathology, including calcification, sclerosis, prolapse, flail, tendon cable rupture, valve degeneration, infective endocarditis, rheumatic lesions, or ischemic lesions; 3. history of previous mitral valve surgery or transcatheter manipulation; 4. mitral valve orifice area \<4 cm2; 5. aortic valve disease requiring surgical or transcatheter intervention; 6. untreated clinically significant coronary artery disease requiring revascularization; 7. history of previous myocardial infarction; 8. previous definitive diagnosis of cardiomyopathies such as dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, arrhythmogenic cardiomyopathy, and infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, and nodular disease) 9. echocardiographic evidence of intracardiac mass or thrombus; 10. implant of cardiac device (pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy device, or left atria appendage closure); 11. hemodynamic instability requiring cardiac assist devices, intra-aortic balloon pump (IABP), or other hemodynamic support; 12. any percutaneous cardiac intervention (percutaneous coronary intervention, transcatheter aortic valve replacement, etc.) within the 30 days prior to randomization, 13. any cardiac surgery within the 6 months prior to randomization; 14. active infections requiring current antibiotic therapy; 15. a known hypersensitivity or contradiction to procedure medications which cannot be adequately managed medically; 16. contraindication to appropriate anti-coagulation therapy; 17. chronic obstructive pulmonary disease (COPD) requiring continuous home oxygen therapy or chronic oral steroid therapy; 18. acute cerebrovascular accident within 30 days prior to randomization or Modified Rankin Score ≥ 4; 19. symptomatic severe carotid stenosis (\>70% by ultrasound); 20. other planned surgical or interventional procedures within the next 3 months; 21. liver failure; 22. renal failure or dialysis status; 23. pregnant or planning pregnancy within the next 3 months; 24. life expectancy \< 12 months (e.g., advanced malignant tumors); 25. currently participating in other interventional studies; 26. circumstances that, in the judgment of the researcher, make participation in this study unsuitable.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation mitral valve insufficiency persistent atrial fibrillation

As listed by the trial registrant

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

Atrial fibrillation (AF) Atrial functional mitral regurgitation Catheter ablation

How to take part

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

  1. The places running it

    17 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

  • Beijing Anzhen Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 100029, China

  • Guangdong Provincial People's Hospital

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510000, China

  • Peking University Third Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100191, China

  • People's Hospital of Ningxia Hui Autonomous Region

    RECRUITING

    Yinchuan, Ningxia, 750002, China

  • Shandong Provincial Qianfoshan Hospital

    RECRUITING

    Jinan, Shandong, 250000, China

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310009, China

  • Tangdu Hospital-Air Force Medical University

    RECRUITING

    Xi’an, Shanxi, 710000, China

  • The First Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, 230022, China

  • The First Affiliated Hospital of Harbin Medical University

    RECRUITING

    Harbin, Heilongjiang, 150001, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    NOT_YET_RECRUITING

    Xi’an, Shanxi, 710061, China

  • The First Affiliated Hospital of Zhengzhou University

    NOT_YET_RECRUITING

    Zhengzhou, Henan, 450052, China

  • The Second Affiliated Hospital of Harbin Medical University

    RECRUITING

    Harbin, Heilongjiang, 450052, China

  • The Second Hospital of Hebeimedical University

    RECRUITING

    Shijiazhuang, Hebei, 050000, China

  • The first hospital of Jilin University

    NOT_YET_RECRUITING

    Changchun, Jilin, 130000, China

  • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430030, China

  • Wuhan Asia Heart Hospital

    RECRUITING

    Wuhan, Hubei, 430022, China

  • Xiamen University Affiliated Cardiovascular Hospital

    NOT_YET_RECRUITING

    Xiamen, Fujian, 361006, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.