RanDOmized stUdy Comparing Both Latest Generation Self-Expanding Valves and a Minimalist approaCH vs. Standard Of Care In transCathEter Aortic Valve Implantation

Who can take part

• Severe symptomatic aortic valve stenosis (AVA ≤1 cm² or 0.6 cm²/m²) with indication for transcatheter aortic valve implantation according to heart team consensus
• Perimeter-derived native aortic valve annulus diameter measuring 21-27 mm
• Heart team consensus that the patient is anatomically suitable for both device types
• Suitability for transfemoral vascular access
• Written informed consent

Who cannot take part

• Active peptic ulcer or upper gastro-intestinal bleeding <2 weeks
• Hypersensitivity or contraindication to aspirin, heparin or clopidogrel
• Contraindication for a specific treatment strategy (minimalist approach vs. standard of care) as judged by the Heart Team
• Active infection requiring antibiotic treatment
• Age <18 years
• Life expectancy <12 months due to comorbidities
• Native aortic valve annulus <21 mm and >27 mm
• Bicuspid aortic valve
• Cardiogenic shock or hemodynamic instability
• Active endocarditis
• Contraindications for transfemoral access
• Clear patient-specific clinical or anatomic reasons to prefer one treatment strategy or valve type over the other
• Participation in another interventional trial where the primary endpoint has not been reached