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

N/ANot Yet RecruitingNCT05977257

Shanghai MicroPort CardioFlow Medtech Co., Ltd.89 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Aortic Valve Disease Aortic Valve Stenosis

Interventions

VitaFlow® Transcatheter Aortic Valve Replacement SystemDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: 1. Participate in clinical trials of other drugs or medical devices and have not yet reached the primary endpoint; 2. The investigator judges that the patient's compliance is poor and the study cannot be completed as required.

Locations (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

Outcomes

Primary Outcomes

All cause mortality

rate of all cause mortality

Time frame: 7years after the operation