VitaFlow® Transcatheter Aortic Valve Replacement System
DeviceThis study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve System pre-market trial
NCT Number: NCT05977257
This study is an observational study to evaluate the long-term safety and effectiveness of the valve system.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Fuwai CVD Hospital of Chinese Academy of Medical Sciences, Beijing, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve System pre-market trial
Time frame: 7years after the operation
rate of all cause mortality
Time frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
rate of Cardiac death
Time frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
rate of stroke
Time frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
rate of valve-related rehospitalization
Time frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
rate of Serious Adverse Event
Time frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
Systolic and Diastolic Blood Pressure
Time frame: 6years, 7years, 8 years, 9 years and 10 years after the operation
Scores range from 0 to 100, higher scores are better
Time frame: 7years,and 10 years after the operation
Transthoracic Echocardiogram test
Time frame: 7years,and 10 years after the operation
Transthoracic Echocardiogram test
Time frame: 7years,and 10 years after the operation
Transthoracic Echocardiogram test
Time frame: 7years,and 10 years after the operation
Transthoracic Echocardiogram test
Time frame: 7years,and 10 years after the operation
Transthoracic Echocardiogram test
Time frame: 7years,and 10 years after the operation
NYHA class
Time frame: 7years,and 10 years after the operation
Kansas City Cardiomyopathy Questionnaire(score 0-100), higher scores are better
Time frame: 7years,and 10 years after the operation
blood test
Time frame: 7years,and 10 years after the operation
Transthoracic Echocardiogram test
Time frame: 7years,and 10 years after the operation
Transthoracic Echocardiogram test
Time frame: 6 years, 8 years, 9 years and 10 years after the operation
rate of all cause mortality
Contact information is provided by the study sponsor or research team.
Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Industry
Acronym: VITAL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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