VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up (VITAL)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai MicroPort CardioFlow Medtech Co., Ltd.

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • VitaFlow® Transcatheter Aortic Valve Replacement System

    Device

    This study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve System pre-market trial

Treatment groups

89 Participants
are divided into 1 treatment group
Group A: Non Interventional long term safety follow up1 intervention

Trial outcomes

Primary outcomes

1

All cause mortality

rate of all cause mortality

Time frame
7years after the operation

Secondary outcomes

1

Cardiac death

rate of Cardiac death

Time frame
6 years, 7 years, 8 years, 9 years and 10 years after the operation
2

Stroke

rate of stroke

Time frame
6 years, 7 years, 8 years, 9 years and 10 years after the operation
3

valve-related rehospitalization

rate of valve-related rehospitalization

Time frame
6 years, 7 years, 8 years, 9 years and 10 years after the operation
4

Serious Adverse Event

rate of Serious Adverse Event

Time frame
6 years, 7 years, 8 years, 9 years and 10 years after the operation

Other outcomes

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: