Mitral Valve Replacement
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMITRIS RESILIA Mitral Valve
Surgical replacement of native or prosthetic mitral valve.
Sponsors
Edwards (Shanghai) Medical Products Co. Ltd.
Kun Tuo Medical Research and Development (Beijing) Co. Ltd.
Chinese Academy of Medical Sciences, Fuwai Hospital
Edwards Lifesciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Performance outcome - Hemodynamics by echocardiography - Subject's Average Mean Gradient Measurements | 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. |
| Primary Performance outcome - Hemodynamics by echocardiography - Subject's Average Peak Gradients Measurements | 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. |
| Primary Safety outcome - Kaplan Meier (KM) rate of valve related death or reintervention | 1 year | Freedom from valve related death or valve related reintervention at 1 year as determined by the CEC. |
| Primary Performance outcome - Hemodynamics by echocardiography - Subject's Amount of Transvalvular regurgitation | 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. |
| Primary Performance outcome - Hemodynamics by echocardiography - Subject's Amount of Paravalvular leak | 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
| Measure | Time frame | Description |
|---|---|---|
| Performance outcome - Hemodynamics by echocardiography Subject's Average Mean Gradient Measurements | 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. |
| New York Heart Association (NYHA) Classification | 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. |
| Performance outcome - Hemodynamics by echocardiography - Subject's Average Peak Gradients Measurements | 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. |
| Performance outcome - Hemodynamics by echocardiography - Subject's Amount of Transvalvular regurgitation | 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. |
| Performance outcome - Hemodynamics by echocardiography - Subject's Amount of Paravalvular leak | 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. |
| Adverse Events | 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 |
Countries
China
Contacts
Primary ContactHonglei Sun
Backup ContactWeiDavid Zhang
Outcome results
None listed