Severe Aortic Valve Stenosis
Conditions
Interventions
one-arm:Transcatheter Aortic Valve Replacement
Sponsors
Department of Cardiology, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 70 years ; 2. Patients with symptomatic severe aortic valve stenosis (evaluated by echocardiography: transaortic valve pressure gradient >= 40mmHg (1mmHg=0.133kPa), or transaortic valve blood flow rate >= 4m/s, or aortic Valve area = II; 4. Life expectancy > 12 months; 5. Patients who are anatomically suitable for transcatheter aortic valve implantation; 6. After evaluation by two or more cardiovascular surgeons, patients who are unsuitable for surgery; or patients who refuse surgery after sufficient communication by the surgeons and are at high risk of routine surgery; 7. Patients who can understand the purpose of the trial, voluntarily participate in and signed informed consent form, and are willing to accept relevant examinations and clinical follow-ups.
Exclusion criteria
Exclusion criteria: 1. Acute myocardial infarction occurred within 1 month before this treatment; 2. Congenital single leaf aortic valve; 3. Any therapeutic cardiac operation (including placement of coronary drug-eluting stents) within 30 days; 4. The patient's heart has been implanted with other artificial heart valves, artificial rings, or severe mitral regurgitation ( > 3+); 5. Blood system diseases or abnormalities, including leukopenia (WBC 28mm; 15. In any case, patients who refuse surgical treatment in emergency situations; 16. Cerebrovascular accident occurred within 3 months, not including transient ischemic attack; 17. Renal insufficiency is decompensated (creatinine>177umol/L), and/or end-stage renal disease requires long-term dialysis; 18. Severe aortic diseases, including abdominal aortic or thoracic aortic aneurysm, obvious curvature of the aortic arch, atherosclerosis of the aortic arch, narrowing of the abdominal or thoracic aorta, and obvious curvature or extension of the thoracic aorta; 19. The iliac-femoral artery is severely obstructed with calcification, severely tortuous or unable to place the 1418F catheter sheath kit; 20. Active infective endocarditis or other active infections; 21. Aortic valve leaflets calcified plaque close to the coronary ostium; 22. Severe disability Alzheimer's disease and unable to take care of oneself in life; 23. Those who have participated in clinical trials of other drugs or medical devices before entering the group and have not yet reached the time limit of the primary research endpoint; 24. The researcher judged that the patient had poor compliance and could not complete the study as required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality within 12 months of TAVI procedure; | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality within 2-5 years of TAVI procedure;Device success after TAVI;Procedural success after TAVI;MI within 30 days, 6 months, 1-5 years of TAVI procedure;All disabling stroke within 30 days, 6 months, 1-5 years of TAVI procedure;Severe bleeding within 30 days, 6 months, 1-5 years of TAVI procedure; | — |
Countries
China
Contacts
Public ContactMao Chen
West China Hospital of Sichuan University
Outcome results
None listed