SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI

CompariSon of secOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in Transcatheter Aortic Valve Implantation (SOLVE-TAVI)

Aim of the study is to demonstrate equivalence of second-generation self-expandable valves (CoreValve Evolut R) in comparison to second-generation balloon-expandable valves (Edwards Sapien 3) and of local anesthesia with conscious sedation in comparison to general anesthesia with respect to safety and efficacy in high-risk patients with severe aortic stenosis undergoing transcatheter aortic valve implantation.

Inclusion Criteria:

• Severe symptomatic aortic valve stenosis defined as aortic valve area (AVA) ≤ 1cm2 or 0.6 cm²/m²
• Age ≥75 years and/or logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) ≥20% and/or Society of Thoracic Surgeons (STS) risk score ≥10% and/or high risk/contraindication to conventional surgical aortic valve replacement
• Native aortic valve annulus measuring 18-29 mm
• Suitability for transfemoral vascular access
• Written informed consent

Exclusion Criteria:

• Life expectancy <12 months due to comorbidities
• Cardiogenic shock or hemodynamic instability
• History of or active endocarditis
• Contraindications for transfemoral access
• Active peptic ulcer or upper gastro-intestinal bleeding <3 months
• Hypersensitivity or contraindication to aspirin, heparin or clopidogrel
• Contraindication for a specific mode of anesthesia as judged by the cardiac anesthesia representative of the Heart Team
• Active infection requiring antibiotic treatment
• Participation in another trial