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.
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.
Study Type
OBSERVATIONAL
Enrollment
250
Surgical replacement of native or prosthetic mitral valve.
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGFuwai Hospital, CAMS & PUMC
Beijing, Beijing Municipality, China
Primary Safety outcome - Kaplan Meier (KM) rate of valve related death or reintervention
Freedom from valve related death or valve related reintervention at 1 year as determined by the CEC.
Time frame: 1 year
Primary Performance outcome - Hemodynamics by echocardiography - Subject's Average Mean Gradient Measurements
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.
Time frame: 1 year
Primary Performance outcome - Hemodynamics by echocardiography - Subject's Average Peak Gradients Measurements
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.
Time frame: 1 year
Primary Performance outcome - Hemodynamics by echocardiography - Subject's Amount of Transvalvular regurgitation
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.
Time frame: 1 year
Primary Performance outcome - Hemodynamics by echocardiography - Subject's Amount of Paravalvular leak
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.
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Xiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian, China
RECRUITINGGuangdong Provincial People's Hospital
Guangzhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGFuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China
RECRUITINGWuhan Asia Heart Hospital
Wuhan, Hubei, China
RECRUITINGNanjing Drum Tower Hospital
Nanjing, Jiangsu, China
RECRUITINGNanjing First Hospital
Nanjing, Jiangsu, China
RECRUITINGThe First Affiliated Hospital of XI'an Jiaotong University
Xi'an, Shaanxi, China
RECRUITING...and 3 more locations
Time frame: 1 year
Performance outcome - Hemodynamics by echocardiography Subject's Average Mean Gradient Measurements
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.
Time frame: 10 years
Performance outcome - Hemodynamics by echocardiography - Subject's Average Peak Gradients Measurements
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.
Time frame: 10 years
Performance outcome - Hemodynamics by echocardiography - Subject's Amount of Transvalvular regurgitation
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.
Time frame: 10 years
Performance outcome - Hemodynamics by echocardiography - Subject's Amount of Paravalvular leak
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.
Time frame: 10 years
Adverse Events
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
Time frame: 10 years
New York Heart Association (NYHA) Classification
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.
Time frame: 10 years