Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study aims to evaluate the feasibility and safety of polymer artificial heart valve designed and developed by Shanghai HeartEpoch Medical technology Co. Ltd. for the treatment of the mitral valve diseases.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polymer Artificial Heart Valve | Experimental | Device: Polymer Artificial Heart Valve Mitral valve replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mitral valve replacement | Device | device: polymer artificial heart valve mitral valve replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| The composite incidence rate of all-cause mortality and reoperation | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Implantation success rate | after the operation | |
| The change of 6 minutes walk testing(6MWT) from baseline | 3months, 6months | |
| Performance evaluation of implanted valves |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Gang Wang | Contact | +8601064412431 | Jiangangwang@ccmu.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital | Recruiting | Beijing | China |
Not provided
| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| D008946 | Mitral Valve Stenosis |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 day after operation, 7 days after operation, 1 months after operation, 3 months after operation. |
| The change of NYHA from basement | 7 days after operation, 30 days after operation, 3 months after operation |