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NCT Number: NCT07059793

MITRIS China Post Market Clinical Follow-up (PMCF) Study

Collect clinical outcomes on acute and long-term safety and performance of the MITRIS RESILIA Mitral Valve, Model 11400M, in subjects requiring replacement of their native or prosthetic mitral valve with or without concomitant procedures.

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Key information

Conditions

Mitral Valve Replacement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Anzhen Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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About this study

The trial is a Multicenter, prospective, single-arm, post-market study designed to collect clinical outcomes in up to 250 Subjects who have received the MITRIS RESILIA Mitral Valve, Model 11400M.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older at the time of informed consent
  • Has a dysfunctional native or prosthetic mitral valve and requires mitral valve replacement surgery
  • Provide signed written informed consent prior to the study participation
  • Willingness to follow protocol requirements

Exclusion criteria

  • Active endocarditis 3 months prior to the procedure
  • Stage 4 renal disease or requiring dialysis (eGFR < 30 is excluded)
  • Less than 2-year life expectancy due to non-cardiovascular life-threatening disease
  • 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.)
  • Participating in a drug or device study that has not reached its primary endpoint. Note: Participation in national registries is not an exclusion.

Treatment and study plan

MITRIS RESILIA Mitral Valve

Device

Surgical replacement of native or prosthetic mitral valve.

Primary outcomes

  1. Primary Safety outcome - Kaplan Meier (KM) rate of valve related death or reintervention

    Time frame: 1 year

    Freedom from valve related death or valve related reintervention at 1 year as determined by the CEC.

  2. Primary Performance outcome - Hemodynamics by echocardiography - Subject's Average Mean Gradient Measurements

    Time frame: 1 year

    Mean gradient is the average flow of blood through the mitral valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve.

  3. Primary Performance outcome - Hemodynamics by echocardiography - Subject's Average Peak Gradients Measurements

    Time frame: 1 year

    Peak gradient is the maximum value measured of flow of blood through the mitral valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve.

  4. Primary Performance outcome - Hemodynamics by echocardiography - Subject's Amount of Transvalvular regurgitation

    Time frame: 1 year

    Transvalvular leak is where a heart valve doesn't close properly, allowing blood to flow backward through the valve itself.

    Transvalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.

  5. Primary Performance outcome - Hemodynamics by echocardiography - Subject's Amount of Paravalvular leak

    Time frame: 1 year

    Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing.

    Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.

Secondary outcomes

  1. Performance outcome - Hemodynamics by echocardiography Subject's Average Mean Gradient Measurements

    Time frame: 10 years

    Mean gradient is the average flow of blood through the mitral valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve.

  2. Performance outcome - Hemodynamics by echocardiography - Subject's Average Peak Gradients Measurements

    Time frame: 10 years

    Peak gradient is the maximum value measured of flow of blood through the mitral valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve.

  3. Performance outcome - Hemodynamics by echocardiography - Subject's Amount of Transvalvular regurgitation

    Time frame: 10 years

    Transvalvular leak is where a heart valve doesn't close properly, allowing blood to flow backward through the valve itself.

    Transvalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.

  4. Performance outcome - Hemodynamics by echocardiography - Subject's Amount of Paravalvular leak

    Time frame: 10 years

    Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing.

    Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.

  5. Adverse Events

    Time frame: 10 years

    Linearized rates of following key events will be presented in early (≤30 days) and late (>30 days) post-operative period. The outcomes will be adjudicated by Clinical Events Committee (CEC) up to 1 year and site-reported outcomes will be presented after completion of 1 year follow-up.

    • Thromboembolism (Stroke, Transient Ischemia Attack (TIA), Non- Cerebral)
    • Valve thrombosis
    • Major bleeding
    • Nonstructural Valve Dysfunction (NSVD)
    • Structural Valve Deterioration (SVD)
    • Endocarditis
    • Valve related reintervention
    • Death

  6. New York Heart Association (NYHA) Classification

    Time frame: 10 years

    Functional improvement from baseline for NYHA Class (all follow-up time points)

    The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.

    Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).

    Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).

    Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.

    Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.

Study contacts

Contact information is provided by the study sponsor or research team.

Honglei Sun

CONTACT

[email protected]

+8610 5641 0883

WeiDavid Zhang

CONTACT

[email protected]

+86 010 56410915

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital
  • Edwards (Shanghai) Medical Products Co. Ltd.
  • Kun Tuo Medical Research and Development (Beijing) Co. Ltd.

Registry information

Official study title

Post-Market Clinical Follow-up Study of Edwards Lifesciences MITRIS RESILIA Mitral Valve in Chinese Population

Acronym: MITRIS China

Important dates

Study start
2025
Primary completion
2028
Study completion
2038
First posted
Jul 11, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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