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| Name | Class |
|---|---|
| Edwards (Shanghai) Medical Products Co. Ltd. | UNKNOWN |
| Kun Tuo Medical Research and Development (Beijing) Co. Ltd. | UNKNOWN |
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MITRIS RESILIA Mitral Valve | Subjects who received the MITRIS RESILIA Mitral Valve, Model 11400M |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MITRIS RESILIA Mitral Valve | Device | Surgical replacement of native or prosthetic mitral valve. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Honglei Sun | Contact | +8610 5641 0883 | Honglei_Sun@edwards.com | |
| WeiDavid Zhang | Contact | +86 010 56410915 | WeiDavid_Zhang@edwards.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Feng, Professor | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100029 | China |
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| 1 year |
| 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. | 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. | 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. | 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.
| 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. | 10 years |
| Fuwai Hospital, CAMS & PUMC | Recruiting | Beijing | Beijing Municipality | 100037 | China |
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| Xiamen Cardiovascular Hospital Xiamen University | Recruiting | Xiamen | Fujian | 361008 | China |
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| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510080 | China |
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| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
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| Fuwai Central China Cardiovascular Hospital | Recruiting | Zhengzhou | Henan | 451460 | China |
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| Wuhan Asia Heart Hospital | Recruiting | Wuhan | Hubei | 430022 | China |
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| Nanjing Drum Tower Hospital | Recruiting | Nanjing | Jiangsu | 210000 | China |
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| Nanjing First Hospital | Recruiting | Nanjing | Jiangsu | 210012 | China |
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| The First Affiliated Hospital of XI'an Jiaotong University | Recruiting | Xi'an | Shaanxi | 710061 | China |
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| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
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| Sichuan Provincial People's Hospital | Recruiting | Chengdu | Sichuan | 610072 | China |
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| Ningbo Medical Center Lihuili Hospital | Recruiting | Ningbo | Zhejiang | 315046 | China |
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