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

MicroPort

Status

Not yet enrolling

Conditions

Aortic Valve Stenosis

Aortic Valve Disease

Treatments

Device: VitaFlow® Transcatheter Aortic Valve Replacement System

Study type

Observational

Funder types

Industry

Identifiers

NCT05977257

VITAL-2023-192R

Details and patient eligibility

About

This study is an observational study to evaluate the long-term safety and effectiveness of the valve system.

Full description

This study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve System pre-market trial (Protocol No. valve -2014-04) in 4 designated research institutions, and follow-up from 6 to 10 years after the procedure, To evaluate the long-term safety and effectiveness of the valve system.

Enrollment

89 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

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.