HANGZHOU Solution for Patients With Bicuspid Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement by Using Supra-annular Structure Based Balloon Sizing Strategy
To compare supra-annular sizing and THV implantation technique (Hangzhou solution) versus annular sizing and THV implantation technique (control group) in bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding valves (SEVs): a randomized superiority trial
• Age ≥ 65 years
• Age \<65 years and age ≥ 60 years with high surgical risk after combing STS Risk Estimate, Katz activities of Daily Living, major Organ System Dysfunction and Procedure-Specific Impediment;
• Severe, bicuspid aortic stenosis:
• Mean gradient ≥40 mmHg
• Maximal aortic valve velocity ≥4.0 m/sec
• Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2)
• NYHA classification ≥ II;
• Type 0, type 1 (Sievers classification) by MDCT
• Perimeter-derived annulus diameter ranges from 20.0 mm to 29.0 mm;
• Transfemoral TAVR
• The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site.