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This study is an observational study to evaluate the long-term safety and effectiveness of the valve system.
This study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve System pre-market trial (Protocol No. valve -2014-04) in 4 designated research institutions, and follow-up from 6 to 10 years after the procedure, To evaluate the long-term safety and effectiveness of the valve system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non Interventional long term safety follow up | Non Interventional long term safety follow up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VitaFlow® Transcatheter Aortic Valve Replacement System | Device | This study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve System pre-market trial |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | rate of all cause mortality | 7years after the operation |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac death | rate of Cardiac death | 6 years, 7 years, 8 years, 9 years and 10 years after the operation |
| Stroke | rate of stroke | 6 years, 7 years, 8 years, 9 years and 10 years after the operation |
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Inclusion Criteria:
Must meet 1, 2, 3, 4 or 1, 5 to be selected:
Patients who have participated in the VitaFlow® transcatheter aortic valve system pre-market trial in the 4 designated research institutions*;
Be able to get in touch with the patient or his legal guardian/relative;
Patients who can understand the purpose and nature of the follow-up of this study, and are willing to cooperate with the follow-up and provide follow-up information;
Sign the informed consent form;
Patients who are known to have died.
Exclusion Criteria:
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Patients who have participated in the VitaFlow® transcatheter aortic valve system pre-market trial
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JIATONG ZHANG | Contact | +8617797187661 | JiaTong.Zhang@microport.com |
| Name | Affiliation | Role |
|---|---|---|
| Daxin Zhou | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai CVD Hospital of Chinese Academy of Medical Sciences | Beijing | China |
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| valve-related rehospitalization | rate of valve-related rehospitalization | 6 years, 7 years, 8 years, 9 years and 10 years after the operation |
| Serious Adverse Event | rate of Serious Adverse Event | 6 years, 7 years, 8 years, 9 years and 10 years after the operation |
| Blood pressure | Systolic and Diastolic Blood Pressure | 6 years, 7 years, 8 years, 9 years and 10 years after the operation |
| The 12-Item Short Form Health Survey (SF-12) | Scores range from 0 to 100, higher scores are better | 6years, 7years, 8 years, 9 years and 10 years after the operation |
| Mean transvalvular pressure gradient | Transthoracic Echocardiogram test | 7years,and 10 years after the operation |
| Effective orifice area | Transthoracic Echocardiogram test | 7years,and 10 years after the operation |
| Peak velocity | Transthoracic Echocardiogram test | 7years,and 10 years after the operation |
| class of Paravalvular leak | Transthoracic Echocardiogram test | 7years,and 10 years after the operation |
| class of Aortic regurgitation | Transthoracic Echocardiogram test | 7years,and 10 years after the operation |
| New York Heart Association Class for heart function | NYHA class | 7years,and 10 years after the operation |
| Kansas City Cardiomyopathy Questionnaire | Kansas City Cardiomyopathy Questionnaire(score 0-100), higher scores are better | 7years,and 10 years after the operation |
| Natriuretic peptide tests ( NT Pro-BNP or BNP) | blood test | 7years,and 10 years after the operation |
| moderate and severe structural valve deterioration SVD | Transthoracic Echocardiogram test | 7years,and 10 years after the operation |
| bioprosthetic valve failure,BVF | Transthoracic Echocardiogram test | 7years,and 10 years after the operation |
| All cause mortality | rate of all cause mortality | 6 years, 8 years, 9 years and 10 years after the operation |
| West China Hospital, Sichuan University | Chengdu | China |
|
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | China |
|
| Zhongshan Hospital Fudan University | Shanghai | China |
|
| 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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