Aortic Valve Disease, Aortic Valve Stenosis
Conditions
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.
Interventions
DEVICEVitaFlow® Transcatheter Aortic Valve Replacement System
This study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve System pre-market trial
Sponsors
Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All cause mortality | 7years after the operation | rate of all cause mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroke | 6 years, 7 years, 8 years, 9 years and 10 years after the operation | rate of stroke |
| valve-related rehospitalization | 6 years, 7 years, 8 years, 9 years and 10 years after the operation | rate of valve-related rehospitalization |
| 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 |
| 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 |
| 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 |
| Cardiac death | 6 years, 7 years, 8 years, 9 years and 10 years after the operation | rate of Cardiac death |
| class of Aortic regurgitation | 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 |
| Kansas City Cardiomyopathy Questionnaire | 7years,and 10 years after the operation | Kansas City Cardiomyopathy Questionnaire(score 0-100), higher scores are better |
| Natriuretic peptide tests ( NT Pro-BNP or BNP) | 7years,and 10 years after the operation | blood test |
| moderate and severe structural valve deterioration SVD | 7years,and 10 years after the operation | Transthoracic Echocardiogram test |
| bioprosthetic valve failure，BVF | 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 |
| class of Paravalvular leak | 7years,and 10 years after the operation | Transthoracic Echocardiogram test |
Countries
China
Contacts
Primary ContactJIATONG ZHANG
Outcome results
None listed