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Clinical Trials in China / NCT05977257
Starting soon Observational

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

NCT05977257 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai MicroPort CardioFlow Medtech Co., Ltd
Phase
Observational
Started
2023-07-30
Last updated
2023-08-04

Condition(s) studied

Aortic Valve DiseaseAortic Valve Stenosis

Investigational drug(s) / intervention(s)

VitaFlow® Transcatheter Aortic Valve Replacement System

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • All cause mortality — 7years after the operation
    rate of all cause mortality

Trial sites (4)

FacilityCityRegionStatus
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

More Shanghai MicroPort CardioFlow Medtech Co., Ltd. trials in China

TAVR vs. SAVR Study of VitaFlow Liberty® for Severe BAV Stenosis Enrolling by invitation
VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial Recruiting
CardioFlow Transcatheter Mitral Valve Replacement System Pre-market Clinical Investigation Starting soon
VitaFlow™ Transcatheter Aortic Valve System Post-market Study-The LAUNCH Study Recruiting

Other trials for the same condition

To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Stenosis Recruiting
Evaluating the Safety and Efficacy of Prosthetic Polymer Heart Valves for the Treatment of Aortic Valve Disease Enrolling by invitation
Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation Recruiting
Aortic Valve Diseases RISk facTOr assessmenT and Prognosis modeL Construction Recruiting
TAVR for Aortic Valve Disease Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05977257 on ClinicalTrials.gov ↗ ← All trials in China