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

Leipzig Heart Science gGmbH

Status: Active, not recruiting

Conditions: Aortic Valve Stenosis

Treatments: Device: ACURATE neo2; Device: CoreValve Evolut Pro, Pro+ and FX; Procedure: minimalist approach; Procedure: Standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT05036018

2021-0165

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 836 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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836 participants in 4 patient groups

Group 1

Active Comparator group

Description:

Patients treated with the ACURATE neo2 valve using a minimalist approach

Treatment:

Procedure: minimalist approach

Device: ACURATE neo2

Group 2

Active Comparator group

Description:

Patients treated with the ACURATE neo2 valve under standard of care

Treatment:

Procedure: Standard of care

Device: ACURATE neo2

Group 3

Active Comparator group

Description:

Patients treated with the Evolut Pro, Pro+ or FX valve using a minimalist approach

Treatment:

Procedure: minimalist approach

Device: CoreValve Evolut Pro, Pro+ and FX

Group 4

Active Comparator group

Description:

Patients treated with the Evolut Pro, Pro+ or FX valve under standard of care

Treatment:

Procedure: Standard of care

Device: CoreValve Evolut Pro, Pro+ and FX