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 objective of this study is to evaluate the long term safety and effectiveness of the SAPIEN 3 Transcatheter Heart Valve system in real world setting.
This is an observational, single-arm, multicentre, post-market study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcatheter Aortic Valve Implantation (TAVI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAPIEN 3 Transcatheter Heart Valve | Device | Implantation of the SAPIEN 3 valve |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | The number of patients that died | 10 years |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Subjects who will undergo TAVI with the Edwards SAPIEN 3 System.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality | 100000 | China | ||
| Xiamen Cardiovascular Hospital Xiamen University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D014694 | Ventricular Outflow Obstruction |
Not provided
Not provided
Not provided
Not provided
Not provided
| Xiamen |
| Fujian |
| 361004 |
| China |
| First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510000 | China |
| Henan Provincial Chest Hospital | Zhengzhou | Henan | 450000 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450000 | China |
| Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | 410000 | China |
| Shanghai General Hospital | Shanghai | Shangahi | 200000 | China |
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | 200000 | China |
| Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200000 | China |
| The First Affiliated Hospital of Xi'an Jiao Tong University | Xi’an | Shanxi | 710000 | China |
| First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | 830000 | China |
| People's Hospital of Xinjiang Uygur Autonomous Region | Ürümqi | Xinjiang | 830000 | China |
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |