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

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

Open-label, 2 x 2 factorial, prospective, randomized, national, multicenter study to compare latest-generation self-expanding valves and a minimalist approach versus standard of care in transcatheter aortic valve implantation.

The purpose of the DOUBEL-CHOICE study is to demonstrate non-inferiority of a latest-generation self-expanding valve (SEV) (ACURATE neo2, Boston Scientific, Marlborough, MA, USA) in comparison to another latest-generation SEV (Evolut Pro, Pro+ and FX, Medtronic Inc., Minneapolis, MN, USA) and of a minimalist approach vs. standard of care with respect to safety and efficacy in patients with severe symptomatic aortic stenosis undergoing transfemoral TAVI.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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
• Clear patient-specific clinical or anatomic reasons to prefer one treatment strategy or valve type over the other
• Active infection requiring antibiotic treatment
• Age <18 years
• Participation in another interventional trial where the primary endpoint has not been reached