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New heart valve study aims to improve mitral replacement outcomes

NCT ID NCT07059793

Disease control Sponsor: Edwards Lifesciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is testing a new artificial heart valve (MITRIS RESILIA) in 250 Chinese patients who need their mitral valve replaced. The goal is to see how safe and well the valve works over time by measuring blood flow and leaks. Participants must be 18 or older and willing to follow the study plan.

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 250 people

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

Started

Jul 2025

Expected to finish

Dec 2038

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Subjects from China who meet all the study inclusion criteria and none of the study exclusion criteria who undergo a mitral valve replacement with the Model 11400M heart valve and voluntary sign a consent form to agree to participate in the study.

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. 18 years or older at the time of informed consent 2. Has a dysfunctional native or prosthetic mitral valve and requires mitral valve replacement surgery 3. Provide signed written informed consent prior to the study participation 4. Willingness to follow protocol requirements Exclusion Criteria: 1. Active endocarditis 3 months prior to the procedure 2. Stage 4 renal disease or requiring dialysis (eGFR \< 30 is excluded) 3. Less than 2-year life expectancy due to non-cardiovascular life-threatening disease 4. High predicted risk of mortality prior to procedure - STS Predicted Risk of Mortality (PROM) \> 8 or Surgeon estimated risk of mortality of \> 8 (STS PROM risk calculation score must be used for patients undergoing Isolated Mitral Valve Replacement (MVR) or MVR+ Coronary Artery Bypass Grafting (CABG). Surgeon estimated risk of mortality may only be used for patients who do not qualify for evaluation against those surgical models.) 5. Participating in a drug or device study that has not reached its primary endpoint. Note: Participation in national registries is not an exclusion.

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Conditions

The condition(s) this trial relates to.

mitral valve disorder

As listed by the trial registrant

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

Mitral valve replacement

How to take part

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

  1. The places running it

    13 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

  • Fuwai Central China Cardiovascular Hospital

    RECRUITING

    Zhengzhou, Henan, 451460, China

  • Fuwai Hospital, CAMS & PUMC

    RECRUITING

    Beijing, Beijing Municipality, 100037, China

  • Guangdong Provincial People's Hospital

    RECRUITING

    Guangzhou, Guangdong, 510080, China

  • Nanjing Drum Tower Hospital

    RECRUITING

    Nanjing, Jiangsu, 210000, China

  • Nanjing First Hospital

    RECRUITING

    Nanjing, Jiangsu, 210012, China

  • Ningbo Medical Center Lihuili Hospital

    RECRUITING

    Ningbo, Zhejiang, 315046, China

  • Qilu Hospital of Shandong University

    RECRUITING

    Jinan, Shandong, 250012, China

  • Sichuan Provincial People's Hospital

    RECRUITING

    Chengdu, Sichuan, 610072, China

  • The First Affiliated Hospital of XI'an Jiaotong University

    RECRUITING

    Xi'an, Shaanxi, 710061, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, 450052, China

  • Wuhan Asia Heart Hospital

    RECRUITING

    Wuhan, Hubei, 430022, China

  • Xiamen Cardiovascular Hospital Xiamen University

    RECRUITING

    Xiamen, Fujian, 361008, China

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