VitaFlow® Transcatheter Aortic Valve Replacement System
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
Study summary
This study is an observational study to evaluate the long-term safety and effectiveness of the valve system.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Must meet 1, 2, 3, 4 or 1, 5 to be selected:
1. Patients who have participated in the VitaFlow® transcatheter aortic valve system pre-market trial in the 4 designated research institutions\*;
2. Be able to get in touch with the patient or his legal guardian/relative;
3. 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;
4. Sign the informed consent form;
5. 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:
1. Participate in clinical trials of other drugs or medical devices and have not yet reached the primary endpoint;
2. The investigator judges that the patient's compliance is poor and the study cannot be completed as required.
Primary outcome measure(s)
All cause mortality — 7years after the operation rate of all cause mortality
Trial sites (4)
Facility
City
Region
Status
Fuwai CVD Hospital of Chinese Academy of Medical Sciences
Beijing
China
West China Hospital, Sichuan University
Chengdu
China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou
China
Zhongshan Hospital Fudan University
Shanghai
China
More Shanghai MicroPort CardioFlow Medtech Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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