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

Last updated: January 15, 2025
Sponsor: Leipzig Heart Science gGmbH
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

minimalist approach

ACURATE neo2

CoreValve Evolut Pro and Pro+

Clinical Study ID

NCT05036018
2021-0165
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Severe symptomatic aortic valve stenosis (AVA ≤1 cm² or 0.6 cm²/m²) with indicationfor 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

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 valvetype over the other

  • Active infection requiring antibiotic treatment

  • Age <18 years

  • Participation in another interventional trial where the primary endpoint has notbeen reached

Study Design

Total Participants: 836
Treatment Group(s): 4
Primary Treatment: minimalist approach
Phase:
Study Start date:
August 30, 2021
Estimated Completion Date:
December 31, 2033

Study 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.

Connect with a study center

  • Zentralklinik Bad Berka

    Bad Berka, 99437
    Germany

    Site Not Available

  • Herz- und Diabeteszentrum NRW

    Bad Oeynhausen, 32545
    Germany

    Site Not Available

  • Segeberger Kliniken GmbH

    Bad Segeberg, 23795
    Germany

    Site Not Available

  • St.-Johannes-Hospital Dortmund

    Dortmund, 44137
    Germany

    Site Not Available

  • Universitätsklinikum Gießen

    Gießen, 35392
    Germany

    Site Not Available

  • Universitätsklinikum Köln

    Köln, 50937
    Germany

    Site Not Available

  • Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology

    Leipzig, 04289
    Germany

    Site Not Available

  • Herzzentrum München

    München, 80636
    Germany

    Site Not Available

  • LMU Klinikum München

    München, 81377
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen

    Tübingen, 72076
    Germany

    Site Not Available

  • Helios Klinikum Wuppertal

    Wuppertal, 42283
    Germany

    Site Not Available

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