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NCT Number: NCT05036018

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zentralklinik Bad Berka, Bad Berka, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACURATE neo2

Device

The ACURATE neo2 valve will be implanted using a two-step mechanism during transfemoral transcatheter aortic valve implantation (TAVI). Balloon predilatation will be recommended in the ACURATE neo 2 valve group.

minimalist approach

Procedure

Isolated local anesthesia. Central venous lines, additional arterial lines for blood pressure monitoring, and urinary catheters will be avoided. Insertion of temporary pacemakers is optional and should be avoided whenever possible, and peri-procedural pacing can then be performed on the left ventricular wire. Patients will be directly transferred to the cardiology ward after the procedure, which can be postponed in case of complications.

CoreValve Evolut Pro, Pro+ and FX

Device

The Evolut Pro, Pro+ or FX valve is positioned in a controlled manner either without pacing or under 'slow-rapid' pacing with allowance for limited repositioning and is anchored to the annulus and ascending aorta.

Standard of care

Procedure

Sedation should be titrated to a Richmond Agitation Sedation Scale (RASS) of 0 to -2 according to local standard of care.The use of EEG monitoring (i.e. BIS, Sedline) can be applied. Continuous CO2-monitoring via face mask should be established during sedation. All patients will receive supplemental oxygen by face mask to maintain an oxygen saturation of approximately 95%. The use of central venous catheters, additional arterial lines for blood pressure monitoring, and urinary catheters can be implemented according to local institutional standards.

Primary outcomes

  1. Devices: Composite of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30-day follow-up

    Time frame: Day 30

  2. 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)

    Time frame: Day 30

Sponsors and collaborators

Lead sponsor

Leipzig Heart Science gGmbH

Other

Collaborators

  • Heart Center Leipzig - University Hospital

Registry information

Acronym: DOUBLE-CHOICE

Important dates

Study start
2021
Primary completion
2025
Study completion
2035
First posted
Sep 5, 2021
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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