Bioprosthetics Valve Failure
Conditions
Interventions
study group:transcatheter valve repalcement
Sponsors
Union hospital tongji medical college huazhong university of science and technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Bioprosthetics valve failure(=moderate stenosis and/or =moderate regurgitation); 2. Age=18 years old who are not in pregnancy or lactation; 3. Cardiac function NYHA = II; 4. Patient who is anatomically suitable for the implantation of the research device ; 5. According to cardiac team , patients are at intermediate or above surgical risk or not suitable for redo open heart surgery of valve replacement; 6. Patients who understand the purpose of the trial and volunteer to participate in, sign the informed consent form and are willing to accept relevant examinations and clinical follow-ups.
Exclusion criteria
Exclusion criteria: 1. Patients with other valvular diseases that require simultaneous intervention; 2. Estimated life expectancy < 12 months; 3. The deteriorated valve has moderate and above paravalvular regurgitation; 4. The deteriorated valve cannot be stably fixed on the original valve ring or the structure is incomplete; 5. Anatomical features are not suitable for transcatheter implantation; 6. Anatomical features increase the risk of left ventricular outflow tract (LVOT) obstruction; 7. Patient with acute myocardial infarction within 30 days; 8. Any therapeutic cardiac operation (excluding previous PCI and pacemaker implantation) is performed within 30 days of the index procedure; 9. Patient with hypertrophic cardiomyopathy with obstruction; 10. Echocardiographic evidence of intracardiac mass, thrombus or vegetation; 11. Patients with active infective endocarditis or other active infections; 12. Patients with severe right ventricular dysfunction, or severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) < 20%; 13. Patients who cannot tolerate anticoagulant or antiplatelet therapy; 14. Patients with severe untreated coronary artery stenosis requiring revascularization; 15. Patients with cerebrovascular accident within 3 months, excluding transient ischemic attack; 16. Patients who refuse surgical treatment in emergency situations under any circumstances; 17. Patients who have severely disabled Alzheimer's disease and inability to take care of themselves; 18. Patients who have participated in clinical trials of other drugs or medical devices before enrollment and have not yet reached the primary outcome of research; 19. The investigator judged that patient with poor compliance and could not complete the study as required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality at 12 momths; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of device success (immediate post-surgical);Rate of procedural success (immediate post-surgical);Rate of all-cause mortality at 30 days, 6 months after surgery;Improvement of NYHA cardiac function at 30 days, 6 months and 12 months after surgery;Rate of severe major cardiovascular and cerebrovascular adverse events in 30 days, 6 months and 12 months after surgery; | — |
Countries
China
Contacts
Public ContactDong Nianguo
Outcome results
None listed