Aortic stenosis
Conditions
Interventions
spatial structure planning group:The valve size is selected according to the parameters of the spatial structure measurement of the aortic root complex
control group:annulus sizing
Sponsors
Department of Cardiology, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1) Patient's age= 18 years old; 2) Severe stenosis of the aortic valve (defined as the effective opening area of the aortic valve = 1.0cm2, or the average transactive valve pressure step =40mmHg, or the transvalvular peak flow rate =4.0m/s) and obvious relevant clinical symptoms; Patients who meet the above echocardiogram inclusion criteria can still be enrolled based on pre-BAVP echocardiogram results if they underwent balloon aortic valvuloplasty (BAVP) prior to baseline surgery and no longer meet the inclusion criteria for effective aortic valve area, mean transvalvular pressure difference of the aortic valve, or transvalvular peak flow rate; 3) The bicuspid aortic valve or leaflet calcification volume = 382mm3 determined by CT; 4) After joint evaluation by the cardiac team (including an interventional specialist and a cardiac surgeon), the decision to choose surgical aortic valve replacement or TAVR treatment is based on factors such as symptoms, age, and life expectancy of the patient, indications for intervention, predicted surgical risk, anatomy, etc. The latest guidelines recommend that treatment is no longer based on surgical risk, and TAVR is preferred including: o Transfemoral TAVR is preferred in patients aged >80 years or life expectancy 12 months and the quality of life is acceptable According to the above principles, patients who are eventually scheduled for TAVR; 5) CT contrast-enhanced cardiovascular scan was used to conduct a detailed assessment of the patient's aortic root anatomy and peripheral vascular conditions, and it was deemed appropriate to perform TAVR through the femoral approach; 6) Patients voluntarily join the trial and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1) Emergency surgery is required for any reason; 2) Have undergone surgical thoracotomy for the aortic valve; 3) history of endocarditis or evidence of other active systemic infection or sepsis within 6 months prior to surgery; 4) Echocardiography shows that the patient has newly formed intracardiac vegetations or intraventricular thrombosis or valve thrombosis, which needs to be treated; 5) The investigators assessed that the life expectancy of the patients was less than 12 months due to other non-cardiac diseases at the time of enrollment; 6) Hypertrophic obstructive cardiomyopathy; 7) severe left ventricular insufficiency, ejection fraction < 20%; 8) untreated conduction system disease (e.g., second-degree type II AV block) or permanent pacemaker inserted; 9) Participate in other drug or device research at the same time
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| postoperative PGmean =20mmHg;increased PGmean=10mmHg;PVL >2;new unset LBBB or high-grade AVB; | — |
Secondary
| Measure | Time frame |
|---|---|
| implantation depth;frame expansion rate; | — |
Countries
China
Contacts
Public ContactChen Mao
West China Hospital, Sichuan University
Outcome results
None listed