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This is a prospective, open, single arm, multi-center clinical study in China. The primary objective of this study is to demonstrate the safety and effectiveness of the PERCEVAL S heart valve when used to replace a diseased native or malfunctioning prosthetic aortic valve in the indicated Chinese population for tissue heart valve replacement and suitable to the PERCEVAL S valve.
The secondary objectives are to collect all relevant device and subject demographics, procedural and hospital discharge, short and long-term data, as described in the secondary endpoints section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aortic Valve Replacement with Perceval S sutureless heart valve | Other | Patient undergoing Aortic Valve Replacement with Perceval S sutureless heart valve |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aortic Valve Replacement with Perceval S sutureless heart valve | Device | Patients will be treated with the PERCEVAL S heart valve (PERCEVAL S valve) which is a bioprosthesis manufactured with bovine pericardium and assembled on a Nitinol stent. The PERCEVAL S valve is designed to offer an alternative to surgically implanted flexible prostheses (stented and stentless biological valves). A special feature of the device is that it is self-anchoring and does not require sutures to be fixed to the implant site. |
| Measure | Description | Time Frame |
|---|---|---|
| composite endpoint of thromboembolism, all bleeding, all paravalvular leak and endocarditis, structural valve deterioration (SVD) and late all cause death (>30 days) | The primary endpoint includes thromboembolism, all bleeding, all paravalvular leak and endocarditis, structural valve deterioration (SVD) and late all cause death (>30 days) per CEC adjudication The number and percentage of subjects with free from thromboembolism, all bleeding, all paravalvular leak and endocarditis, structural valve deterioration (SVD) and late all cause death will be presented, along with individual component of the success. | at one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Gaggianesi | Corcym S.r.l | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital CAMS&PUMC | Beijing | China |
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| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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