Severe aortic stenosis, severe valve dysfunction after valvuloplasty ring/prosthetic valve replacement
Conditions
Interventions
experimental group:transcatheter valve repalcement
Sponsors
Internal Medicine-Cardiovascular Department of West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Confirmed by echocardiography: (1) Patients with severe aortic stenosis (trans-aortic valve blood flow velocity >= 4.0m/s, or trans-aortic valve pressure difference >= 40mmHg (1 mmHg=0.133kPa), or aortic valve Valve area = II; 3. The cardiac team (must include an interventional specialist and a cardiac surgeon at the site) unanimously agree that the patient is at extreme or moderate to high risk for surgical valve replacement [Society of Thoracic Surgeons (STS) score >=4%] and is suitable for Transcatheter valve replacement, where patients are believed to benefit from transcatheter valve replacement; 4. The patient (or his legal representative) understands the requirements of the study and the treatment process, and signs the informed consent; 5. The patient, family members, and/or their legal representatives agree and the patient can return to the study hospital to which he belongs for follow-up according to the study plan.
Exclusion criteria
Exclusion criteria: 1. Acute myocardial infarction occurred within 1 month before this treatment; 2. Congenital unicuspid aortic valve; 3. Any invasive cardiac procedures (including placement of coronary drug-eluting stents) within 30 days; 4. Hematological diseases or abnormalities, including leukopenia (WBC<3x10^9/L), acute anemia (HB<90g/L), thrombocytopenia (PLT<50x10^9/L), bleeding constitution and coagulation disorders; 5. Severe untreated coronary stenosis requiring revascularization; 6. Patients with unstable hemodynamics or breathing who require continuous mechanical cardiac assistance or mechanical ventilation; 7. Patients who need emergency surgery for any reason; 8. Hypertrophic cardiomyopathy with obstruction; 9. Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) <20%; 10. Echocardiography indicates the presence of intracardiac mass, thrombus or vegetation; 11. History of acute peptic ulcer or upper gastrointestinal bleeding within 3 months; 12. Allergic to cobalt-chromium alloys or contrast agents, unable to tolerate anticoagulation and antiplatelet therapy; 13. Patients who refuse emergency surgical treatment under any circumstances; 14. Cerebrovascular accident occurred within 3 months, excluding transient ischemic attack; 15. Severe renal insufficiency and decompensation, and/or end-stage renal disease requiring long-term dialysis; 16. Severe aortic disease, including abdominal or thoracic aortic aneurysm, significant curvature of the aortic arch, atherosclerosis of the aortic arch, stenosis of the abdominal or thoracic aorta, and marked curvature or extension of the thoracic aorta; 17. Severe obstructive calcification of the iliac-femoral artery, severe tortuosity or inability to place a 14-18F catheter sheath; 18. Active stage of infective endocarditis or other active infection; 19. The calcified plaque of the aortic valve leaflet is close to the coronary ostium; 20. Severe incapacitating Alzheimer's disease and unable to take care of themselves; 21. Those who have participated in clinical trials of other drugs or medical devices before enrolling in the group and have not yet reached the time limit of the primary research endpoint; 22. The investigator judges that the patient has poor compliance and cannot complete the study as required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30 days Procedure success rate; | — |
Countries
China
Contacts
Public ContactChen Mao
West China Hospital of Sichuan University
Outcome results
None listed