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Not yet recruiting NCT05977257

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

— Observational Aortic Valve Disease Aortic Valve Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VitaFlow® Transcatheter Aortic Valve Replacement System.
Who it may be relevant to
Registry conditions: Aortic Valve Disease, Aortic Valve Stenosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Detailed 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.

Interventions

  • Device 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

Primary outcome measures

  • All cause mortality [Time frame: 7years after the operation]
Secondary outcome measures (12)
  • Cardiac death [Time frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation]
  • Stroke [Time frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation]
  • valve-related rehospitalization [Time frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation]
  • Serious Adverse Event [Time frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation]
  • Blood pressure [Time frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation]
  • The 12-Item Short Form Health Survey (SF-12) [Time frame: 6years, 7years, 8 years, 9 years and 10 years after the operation]
  • Mean transvalvular pressure gradient [Time frame: 7years,and 10 years after the operation]
  • Effective orifice area [Time frame: 7years,and 10 years after the operation]
  • Peak velocity [Time frame: 7years,and 10 years after the operation]
  • class of Paravalvular leak [Time frame: 7years,and 10 years after the operation]
  • class of Aortic regurgitation [Time frame: 7years,and 10 years after the operation]
  • New York Heart Association Class for heart function [Time frame: 7years,and 10 years after the operation]

Eligibility criteria

Inclusion criteria

  • Must meet 1, 2, 3, 4 or 1, 5 to be selected:
  • 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;
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 4 centers
  • Fuwai CVD Hospital of Chinese Academy of Medical Sciences — Beijing
  • West China Hospital, Sichuan University — Chengdu
  • The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou
  • Zhongshan Hospital Fudan University — Shanghai

Identifiers

NCT: NCT05977257 · VITAL-2023-192R

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗