Status:
NOT_YET_RECRUITING
VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL）
Lead Sponsor:
Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Conditions:
Aortic Valve Disease
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Brief Summary
This study is an observational study to evaluate the long-term safety and effectiveness of the valve system.
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 30 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 30 2028
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT05977257
Start Date
July 30 2023
End Date
October 30 2028
Last Update
August 4 2023
Active Locations (4)
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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