About this trial
This study is an observational study to evaluate the long-term safety and effectiveness of the valve system.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial population
Patients who have participated in the VitaFlow® transcatheter aortic valve system pre-market trial
Trial design
Cohort
Prospective
Treatments tested in this trial
VitaFlow® Transcatheter Aortic Valve Replacement System
DeviceThis study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve System pre-market trial
Treatment groups
Trial outcomes
Primary outcomes
All cause mortality
rate of all cause mortality
Secondary outcomes
Cardiac death
rate of Cardiac death
Stroke
rate of stroke
valve-related rehospitalization
rate of valve-related rehospitalization
Serious Adverse Event
rate of Serious Adverse Event
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: