VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL）
Study Details
Study Description
Brief Summary
This study is an observational study to evaluate the long-term safety and effectiveness of the valve system.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Non Interventional long term safety follow up Non Interventional long term safety follow up |
Device: VitaFlow® Transcatheter Aortic Valve Replacement System
This study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve System pre-market trial
|
Outcome Measures
Primary Outcome Measures
- All cause mortality [7years after the operation]
rate of all cause mortality
Secondary Outcome Measures
- Cardiac death [6 years, 7 years, 8 years, 9 years and 10 years after the operation]
rate of Cardiac death
- Stroke [6 years, 7 years, 8 years, 9 years and 10 years after the operation]
rate of stroke
- valve-related rehospitalization [6 years, 7 years, 8 years, 9 years and 10 years after the operation]
rate of valve-related rehospitalization
- Serious Adverse Event [6 years, 7 years, 8 years, 9 years and 10 years after the operation]
rate of Serious Adverse Event
- Blood pressure [6 years, 7 years, 8 years, 9 years and 10 years after the operation]
Systolic and Diastolic Blood Pressure
- The 12-Item Short Form Health Survey (SF-12) [6years, 7years, 8 years, 9 years and 10 years after the operation]
Scores range from 0 to 100, higher scores are better
- Mean transvalvular pressure gradient [7years,and 10 years after the operation]
Transthoracic Echocardiogram test
- Effective orifice area [7years,and 10 years after the operation]
Transthoracic Echocardiogram test
- Peak velocity [7years,and 10 years after the operation]
Transthoracic Echocardiogram test
- class of Paravalvular leak [7years,and 10 years after the operation]
Transthoracic Echocardiogram test
- class of Aortic regurgitation [7years,and 10 years after the operation]
Transthoracic Echocardiogram test
- New York Heart Association Class for heart function [7years,and 10 years after the operation]
NYHA class
- Kansas City Cardiomyopathy Questionnaire [7years,and 10 years after the operation]
Kansas City Cardiomyopathy Questionnaire(score 0-100), higher scores are better
- Natriuretic peptide tests ( NT Pro-BNP or BNP) [7years,and 10 years after the operation]
blood test
- moderate and severe structural valve deterioration SVD [7years,and 10 years after the operation]
Transthoracic Echocardiogram test
- bioprosthetic valve failure，BVF [7years,and 10 years after the operation]
Transthoracic Echocardiogram test
- All cause mortality [6 years, 8 years, 9 years and 10 years after the operation]
rate of all cause mortality
Eligibility Criteria
Criteria
Inclusion Criteria:
- Must meet 1, 2, 3, 4 or 1, 5 to be selected:
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Patients who have participated in the VitaFlow® transcatheter aortic valve system pre-market trial in the 4 designated research institutions*;
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Be able to get in touch with the patient or his legal guardian/relative;
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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;
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Sign the informed consent form;
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fuwai CVD Hospital of Chinese Academy of Medical Sciences | Beijing | China | ||
| 2 | West China Hospital, Sichuan University | Chengdu | China | ||
| 3 | The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | China | ||
| 4 | Zhongshan Hospital Fudan University | Shanghai | China |
Sponsors and Collaborators
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Investigators
- Principal Investigator: Daxin Zhou, Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VITAL-2023-192R