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

Not Applicable

Active, not recruiting

• Conditions: Aortic Valve Stenosis
• Interventions: Device: ACURATE neo2; Procedure: minimalist approach; Procedure: Standard of care; Device: CoreValve Evolut Pro and Pro+

• Registration Number: NCT05036018
• Lead Sponsor: Leipzig Heart Science gGmbH

Brief Summary

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.

Detailed 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 and Pro+, 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.

Study Timeline

• Study Start: 2021-08-30
• Study First Submitted: 2021-08-30
• Study First Submitted QC: 2021-08-30
• Study First Posted: 2021-09-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21
• Primary Completion: 2025-06-30
• Study Completion: 2033-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 836

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 minimalist approach
• Clear patient-specific clinical or anatomic reasons to prefer one approach 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group 1	ACURATE neo2	Patients treated with the ACURATE neo2 valve using a minimalist approach
Group 1	minimalist approach	Patients treated with the ACURATE neo2 valve using a minimalist approach
Group 2	Standard of care	Patients treated with the ACURATE neo2 valve under standard of care
Group 4	Standard of care	Patients treated with the Evolut Pro or Pro+ valve under standard of care
Group 3	minimalist approach	Patients treated with the Evolut Pro or Pro+ valve using a minimalist approach
Group 2	ACURATE neo2	Patients treated with the ACURATE neo2 valve under standard of care
Group 3	CoreValve Evolut Pro and Pro+	Patients treated with the Evolut Pro or Pro+ valve using a minimalist approach
Group 4	CoreValve Evolut Pro and Pro+	Patients treated with the Evolut Pro or Pro+ valve under standard of care

Primary Outcome Measures

Name	Time	Method
Devices: Composite of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30-day follow-up	Day 30
Strategy: composite of all-cause mortality vascular complications (major + minor according to VARC-3), bleeding complications (type 1-4 according to VARC-3), infections requiring antibiotic treatment, and neurologic events (NeuroARC type 1-3)	Day 30

Trial Locations

Locations (10)

Universitätsklinikum Köln; 🇩🇪 Köln, Germany

LMU Klinikum München; 🇩🇪 München, Germany

Zentralklinik Bad Berka; 🇩🇪 Bad Berka, Germany

Herz- und Diabeteszentrum NRW; 🇩🇪 Bad Oeynhausen, Germany

Herzzentrum München; 🇩🇪 München, Germany

Universitätsklinikum Tübingen; 🇩🇪 Tübingen, Germany

Helios Klinikum Wuppertal; 🇩🇪 Wuppertal, Germany

St.-Johannes-Hospital Dortmund; 🇩🇪 Dortmund, Germany

Universitätsklinikum Gießen; 🇩🇪 Gießen, Germany

Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology; 🇩🇪 Leipzig, Germany