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

Not yet recruiting

• Conditions: Aortic Valve Disease; Aortic Valve Stenosis
• Interventions: Device: VitaFlow® Transcatheter Aortic Valve Replacement System

• Registration Number: NCT05977257
• Lead Sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd.

Brief Summary

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.

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-10
• Study First Submitted QC: 2023-07-28
• Last Update Submitted: 2023-07-28
• Study Start: 2023-07-30
• Study First Posted: 2023-08-04
• Last Update Posted: 2023-08-04
• Primary Completion: 2025-10-30
• Study Completion: 2028-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 89

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non Interventional long term safety follow up	VitaFlow® Transcatheter Aortic Valve Replacement System	Non Interventional long term safety follow up

Primary Outcome Measures

Name	Time	Method
All cause mortality	7years after the operation	rate of all cause mortality

Secondary Outcome Measures

Name	Time	Method
Stroke	6 years, 7 years, 8 years, 9 years and 10 years after the operation	rate of stroke
class of Aortic regurgitation	7years,and 10 years after the operation	Transthoracic Echocardiogram test
bioprosthetic valve failure，BVF	7years,and 10 years after the operation	Transthoracic Echocardiogram test
Cardiac death	6 years, 7 years, 8 years, 9 years and 10 years after the operation	rate of Cardiac death
Serious Adverse Event	6 years, 7 years, 8 years, 9 years and 10 years after the operation	rate of Serious Adverse Event
Blood pressure	6 years, 7 years, 8 years, 9 years and 10 years after the operation	Systolic and Diastolic Blood Pressure
Effective orifice area	7years,and 10 years after the operation	Transthoracic Echocardiogram test
Peak velocity	7years,and 10 years after the operation	Transthoracic Echocardiogram test
class of Paravalvular leak	7years,and 10 years after the operation	Transthoracic Echocardiogram test
valve-related rehospitalization	6 years, 7 years, 8 years, 9 years and 10 years after the operation	rate of valve-related rehospitalization
The 12-Item Short Form Health Survey (SF-12)	6years, 7years, 8 years, 9 years and 10 years after the operation	Scores range from 0 to 100, higher scores are better
Mean transvalvular pressure gradient	7years,and 10 years after the operation	Transthoracic Echocardiogram test
New York Heart Association Class for heart function	7years,and 10 years after the operation	NYHA class
Natriuretic peptide tests ( NT Pro-BNP or BNP)	7years,and 10 years after the operation	blood test
Kansas City Cardiomyopathy Questionnaire	7years,and 10 years after the operation	Kansas City Cardiomyopathy Questionnaire(score 0-100), higher scores are better
moderate and severe structural valve deterioration SVD	7years,and 10 years after the operation	Transthoracic Echocardiogram test
All cause mortality	6 years, 8 years, 9 years and 10 years after the operation	rate of all cause mortality

Trial Locations

Locations (4)

West China Hospital, Sichuan University; 🇨🇳 Chengdu, China

Fuwai CVD Hospital of Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China

The Second Affiliated Hospital Zhejiang University School of Medicine; 🇨🇳 Hangzhou, China

Zhongshan Hospital Fudan University; 🇨🇳 Shanghai, China