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The objective of this study is to evaluate the medium- to long-term safety of the Carbomedics OptiForm Mitral Heart Valve after the implantation for mitral valve disease in the Chinese population.
The study is designed as a post-market, retrospective, single arm and multicentric data collection
This study is conducted to evaluate the medium and long-term safety of the Carbomedics OptiForm Mitral Heart Valve after the implantation for mitral valve disease. The data will be used for regulatory purposes, to support the re-certification of the valve in the Chinese market.
Valve-related SAEs such as prosthetic valve dysfunction, death, valve-related bleeding events, valve thrombosis and thromboembolic events, endocarditis and reintervention will be studied to describe the safety profile of the valve. Data of approximately 400 subjects will be collected in two clinical sites in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects who have been implanted with the Carbomedics OptiForm Mitral Heart Valve | Mitral Valve Replacement with Carbomedics OptiForm Mitral Heart Valve |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitral Valve Replacement | Device | Mitral Valve Replacement with Carbomedics OptiForm Mitral Heart Valve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prosthetic Valve Dysfunction | The number and percentage of subjects with Prosthetic valve Dysfuntion | up to 7-8 year |
| Mortality | The number and percentage of subjects died | up to 7-8 year |
| Valve-related bleeding | The number and percentage of subjects with Valve-related bleeding | up to 7-8 year |
| Valve thrombosis | The number and percentage of subjects with Valve Thrombosis | up to 7-8 year |
| Thromboembolism | The number and percentage of subjects with Thromboembolic events | up to 7-8 year |
| Endocarditis | The number and percentage of subjects with Endocarditis | up to 7-8 year |
| Valve-Related Reintervention | The number and percentage of subjects underwent Valve-related reintervention | up to 7-8 year |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who have been implanted with the Carbomedics OptiForm Mitral Heart Valve
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steven Zhang | Contact | +86 138 1023 2090 | steven.zhang@corcym.com | |
| Michela Paroli | Contact | +39 348 8660149 | michela.paroli@corcym.com |
| Name | Affiliation | Role |
|---|---|---|
| Sara Gaggianesi | Corcym S.r.l | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second Xiangya Hospital of Central South University | Recruiting | Changsha | China |
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| West China hospital of Sichuan University | Recruiting | Chendu | China |
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