aortic stenosis
Conditions
Interventions
Group A:Completing TAVR Operations with TA-J-Valve
Group B:Completing TAVR Operations with other-Valve
Sponsors
Beijing Anzhen Hospital
Eligibility
Sex/Gender
All
Age
65 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age = 65 years 2. preoperative angiographic CT-FFR nadir in all three coronary arteries (left anterior descending coronary artery/left coronary artery circumflex branch/right coronary artery) = 0.8 3. severe symptomatic aortic stenosis; 4. Definition of severe aortic stenosis: ultrasound manifestations (fulfilment of one of the following): - Aortic valve orifice area <1 cm². - Peak antegrade aortic flow velocity = 4.0 m/s - Mean transvalvular pressure difference = 40 mmHg. 5. 5. the subject is assessed to be at high surgical risk (STS = 8) or unsuitable for routine surgery (assessed as unsuitable by two or more senior cardiac surgeons) 6. aortic anatomy suitable for transcatheter aortic valve replacement as assessed by the investigator; 7. the subject signs a written informed consent form and agrees to co-operate with all follow-up examinations.
Exclusion criteria
Exclusion criteria: 1. active endocarditis; 2. acute myocardial infarction or unstable angina or severe coronary artery stenosis requiring coronary revascularisation within 3 months; 3. stroke or TIA (transient ischaemic attack) within the last 3 months; 4. echocardiographic findings of any intracardiac mass, left ventricular or atrial thrombus, or redundant organisms; 5. severe obstructive hypertrophic cardiomyopathy (peak LVOTG = 30 mmHg at rest); Note: Based on the paper: Chinese Guidelines for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy in Adults 2023. 6. 6. history of bleeding tendency or coagulopathy or refusal of blood transfusion; 7. active gastric ulcer or active gastrointestinal (GI) bleeding within 3 months; 8. contraindication to anticoagulation or contraindication to antiplatelets; 9. a combination of other valvular pathologies that are severe enough to require concurrent surgical intervention; 10. previous aortic valve grafts (mechanical or bioprosthesis); 11. severe left ventricular hypofunction with a left ventricular ejection fraction < 20%; 12. hepatic encephalopathy or acute active hepatitis; 13. renal insufficiency (eGFR < 30 ml/min according to the Cockcroft-Gault formula) and/or on renal replacement therapy; 14. persons with poor compliance, such as those with severe dementia, who cannot be assured of completing the study; 15. who require urgent surgery for any reason; 16. known allergy to contrast media or Nitinol memory alloys or bovine products or porcine products; 17. those who are pregnant or planning to become pregnant, or patients taking oestrogen or oestrogen-like medication (women suspected of being pregnant must have a negative serum or urine test for human chorionic gonadotropin prior to inclusion in the study); 18. bileaflet aortic valve; 19. other patients who, in the opinion of the investigator, are not suitable for participation in this clinical study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of moderate commissural alignment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of patients with coronary flow limitation after TAVR;Technical success rate;All-cause mortality;Incidence of permanent pacemakers;New York Heart Association Cardiac Classification (NYHA);Incidence of valve leaflet microthrombosis;Incidence of myocardial infarction;Valvular and cardiac function evaluation;Other complications(bleeding/AKI/stroke); | — |
Countries
China
Contacts
Public ContactZhang Haibo
Beijing Anzhen Hospital
Outcome results
None listed