To compare down sizing strategy versus annular sizing strategy technique (control group) in Type 0 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 (≥ 8%), Katz activities of Daily Living, major Organ System Dysfunction and Procedure-Specific Impediment;
Severe, bicuspid aortic stenosis: Mean gradient ≥40 mmHg OR Maximal aortic valve velocity ≥4.0 m/sec OR Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2); if SVi <35mL/m2, low-dose dobutamine stress echocardiography is required;
NYHA classification ≥ II;
Any contra-indication for Self-expanding bioprosthetic aortic valve deployment Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), Thrombocytopenia (Plt< 50,000 cell/mL).
Active sepsis, including active bacterial endocarditis with or without treatment;
Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment [(defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)].
Stroke or transient ischemic attack (TIA) within 3 months (90 days) of the procedure.
Parallel
TAVR for BAV Using Down Sizing with the Evolut Pro platform
Procedure/SurgeryDown sizing strategy in Type 0 bicuspid aortic stenosis patients undergoing transcatheter aortic valve replacement with self-expanding valves
TAVR for BAV Using Traditional Sizing strategy with the Evolut Pro platform
Procedure/SurgeryTraditional sizing strategy in Type 0 bicuspid aortic stenosis patients undergoing transcatheter aortic valve replacement with self-expanding valves
Composite endpoint of Clinical Event Rate of Device Success (VARC-3), Free of pacemaker implantation, and Free of new onset complete left bundle branch block at 1 month
Composite endpoint of Device Success (VARC-3), Free of pacemaker implantation, and Free of new onset complete left bundle branch block at 1 month
New onset complete left bundle branch block
New onset complete left bundle branch block with QRS ≥120ms at 1 month
Permanent pacemaker implantation
Permanent pacemaker implantation within one month
Device success Rate
Device success per VARC-3 definition
More than (≥) moderate regurgitation
More than (≥) moderate regurgitation on echocardiography at 1month
Click on the lead sponsor to view all of their trials.
