VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL）

Study Overview
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Brief Summary
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This study is an observational study to evaluate the long-term safety and effectiveness of the valve system.

Detailed Description
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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.

Official Title
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VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL）

Conditions
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Aortic Valve Disease, Aortic Valve Stenosis

Intervention / Treatment
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* Device: VitaFlow® Transcatheter Aortic Valve Replacement System


Participation Criteria
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Eligibility Criteria
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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. 4 research institutions: Zhongshan Hospital Fudan University, Second Affiliated Hospital of Zhejiang University School of Medicine, West China Hospital of Sichuan University and Fuwai Hospital. Exclusion Criteria: Participate in clinical trials of other drugs or medical devices and have not yet reached the primary endpoint; The investigator judges that the patient's compliance is poor and the study cannot be completed as required.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non Interventional long term safety follow up<br>Non Interventional long term safety follow up | Device: VitaFlow® Transcatheter Aortic Valve Replacement System<br>* This study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve System pre-market trial<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality | rate of all cause mortality | 7years after the operation | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |