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

Aortic Valve Stenosis Clinical Trial

— VITAL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05977257
• Other study ID #: VITAL-2023-192R
• Status: Not yet recruiting
• Start date: July 30, 2023
• Est. completion date: October 30, 2028

Study information

• Verified date: July 2023
• Source: Shanghai MicroPort CardioFlow Medtech Co., Ltd.
• Contact: JIATONG ZHANG
• Phone: +8617797187661
• Email: JiaTong.Zhang[@]microport.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 89
• Est. completion date: October 30, 2028
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Disease
• Aortic Valve Stenosis

Intervention

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

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai MicroPort CardioFlow Medtech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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