VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL）
VITAL
1 other identifier
observational
89
1 country
4
Brief Summary
This study is an observational study to evaluate the long-term safety and effectiveness of the valve system.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2023
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2023
CompletedStudy Start
First participant enrolled
July 30, 2023
CompletedFirst Posted
Study publicly available on registry
August 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2028
ExpectedAugust 4, 2023
July 1, 2023
2.3 years
July 10, 2023
July 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
All cause mortality
rate of all cause mortality
7years after the operation
Secondary Outcomes (17)
Cardiac death
6 years, 7 years, 8 years, 9 years and 10 years after the operation
Stroke
6 years, 7 years, 8 years, 9 years and 10 years after the operation
valve-related rehospitalization
6 years, 7 years, 8 years, 9 years and 10 years after the operation
Serious Adverse Event
6 years, 7 years, 8 years, 9 years and 10 years after the operation
Blood pressure
6 years, 7 years, 8 years, 9 years and 10 years after the operation
- +12 more secondary outcomes
Study Arms (1)
Non Interventional long term safety follow up
Non Interventional long term safety follow up
Interventions
This study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve System pre-market trial
Eligibility Criteria
Patients who have participated in the VitaFlow® transcatheter aortic valve system pre-market trial
You may qualify if:
- 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.
- research institutions: Zhongshan Hospital Fudan University, Second Affiliated Hospital of Zhejiang University School of Medicine, West China Hospital of Sichuan University and Fuwai Hospital.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daxin Zhou
Fudan University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2023
First Posted
August 4, 2023
Study Start
July 30, 2023
Primary Completion
October 30, 2025
Study Completion (Estimated)
October 30, 2028
Last Updated
August 4, 2023
Record last verified: 2023-07