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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Valve Stenosis; Aortic Valve Disease
• Intervention / Treatment: Device: VitaFlow® Transcatheter Aortic Valve Replacement 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 Type: Observational
• Enrollment (Estimated): 89

Contacts and Locations

• Study Contact: Name: JIATONG ZHANG; Phone Number: +8617797187661; Email: JiaTong.Zhang@microport.com

Study Locations

• China
  • Beijing, China
    • Fuwai CVD Hospital of Chinese Academy of Medical Sciences
    • Contact: Yongjian Wu
  • Chengdu, China
    • West China Hospital, Sichuan University
    • Contact: Yuan Feng
  • Hangzhou, China
    • The Second Affiliated Hospital Zhejiang University School of Medicine
    • Contact: jianan Wang
  • Shanghai, China
    • Zhongshan Hospital Fudan University
    • Contact: Daxin Zhou
    • Principal Investigator: Daxin Zhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who have participated in the VitaFlow® transcatheter aortic valve system pre-market trial

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non Interventional long term safety follow up	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality	rate of all cause mortality	7years after the operation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd.
• Investigators: Principal Investigator: Daxin Zhou, Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2023
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): October 30, 2028

Study Registration Dates

• First Submitted: July 10, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 4, 2023

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Disease
• Other Study ID Numbers: VITAL-2023-192R

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No