VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL）
Key facts
- Where
- Beijing, Chengdu, Hangzhou, and Shanghai, ChinaSee the 4 sites
Where in China
- Fuwai CVD Hospital of Chinese Academy of Medical SciencesBeijing, ChinaContact: Yongjian WuNo longer taking part
- West China Hospital，Sichuan UniversityChengdu, ChinaContact: Yuan FengNo longer taking part
- The Second Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaContact: Jianan WangNo longer taking part
- Zhongshan Hospital,Fudan UniversityShanghai, ChinaContact: Daxin ZhouNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
- Trial code
- NCT05977257
- Record updated
- 4 August 2023
- Original description
This study is an observational study to evaluate the long-term safety and effectiveness of the valve system.Read full original descriptionShow less
This study is an observational study to evaluate the long-term safety and effectiveness of the valve system.
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.