TAVR vs SAVR in Severe Bicuspid Aortic Stenosis

Ki vehet részt

• 50 years of age or older at time of consent
• Severe AS deemed suitable for a bioprosthesis by a local heart team (unsuitable or patient declined a mechanical valve or Ross procedure, following demonstration of evidence-based shared decision making with a validated decision-aid(1)
• Gated contrast CT available and suitable for core laboratory analysis
• BAV anatomy confirmed by CT core laboratory analysis

Ki nem vehet részt

• Recent cardiovascular intervention within 30 days prior to randomization
• Site plan for treatment of concomitant non-coronary cardiovascular disease in the event of randomization to surgery (for instance, concomitant valve surgery, septal defect or coarctation repair, aorta or root replacement or repair)
• Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days prior to randomization
• Stroke or transient ischemic attack (TIA) within 90 days prior to randomization
• Severe lung disease (FEV1 < 50% predicted), unresolved prior to randomization
• In the presence of coronary artery disease deemed necessary for revascularization in the event of randomization to SAVR or TAVR, Syntax score ≥ 32 or deemed unsuitable for PCI, or deemed unsuitable for coronary artery bypass grafting (CABG)
• History of liver disease defined as MELD Score ≥ 10 or Child-Pugh Class B or C
• Unable to complete the KCCQ due cognitive impairment or other medical condition
• Associated aortopathy (AA≥45mm by maximal cross-sectional dimension, as confirmed by CT core laboratory analysis, or AA<45mm but site plan for surgery of the aorta in the event of randomization to surgery
• Leukopenia (WBC < 3000 cells/µL), anemia (Hgb < 8 g/dL), Thrombocytopenia (Plt < 50,000 cells/µL) on latest available labs within 30 days prior to randomization
• LVEF < 25% within 90 days prior to randomization
• Renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula)
• Presence of an existing TAVR or SAVR device
• Pregnancy or lactation
• Extreme or prohibitive TAVR or SAVR risk, adjudicated by Patient Selection Committee (PSC) Review
• Active enrollment in another investigational study
• Disproportionate TAVR vs SAVR risk, as adjudicated by the patient selection committee
• Plan to use any device other than commercially approved Edwards balloon expandable or Medtronic self-expanding TAVR