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Active, not recruitingNCT05036018DOUBLE-CHOICEUpdated Feb 11, 2026

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

An interventional study of ACURATE neo2 and minimalist approach in Aortic Valve Stenosis, sponsored by Leipzig Heart Science gGmbH. Active, not recruiting at 10 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-11.

Sponsored by Leipzig Heart Science gGmbH · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
836
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

Read the 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, 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.

02

Conditions studied

  • Aortic Valve Stenosis

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Keywords

  • TAVI
  • ACURATE neo2
  • Evolut Pro
  • local anesthesia
  • conscious sedation
  • monitored anesthesia care
  • minimalist approach
03

In context

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.

This study's enrollment of 836 is above the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

Leipzig Heart Science gGmbH is the lead sponsor of 8 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
836 participants (actual)

Study arms

  • Active comparator
    Group 1

    Patients treated with the ACURATE neo2 valve using a minimalist approach

    Device: ACURATE neo2 · Procedure: minimalist approach

  • Active comparator
    Group 2

    Patients treated with the ACURATE neo2 valve under standard of care

    Device: ACURATE neo2 · Procedure: Standard of care

  • Active comparator
    Group 3

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

    Procedure: minimalist approach · Device: CoreValve Evolut Pro, Pro+ and FX

  • Active comparator
    Group 4

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

    Device: CoreValve Evolut Pro, Pro+ and FX · Procedure: Standard of care

Interventions

  • DeviceACURATE neo2

    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.

  • Procedureminimalist approach

    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.

  • DeviceCoreValve Evolut Pro, Pro+ and FX

    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.

  • ProcedureStandard of care

    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.

06

What researchers measure

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

07

Study locations

10 sites
  • Zentralklinik Bad Berka
    Bad Berka, 99437, Germany
  • Herz- und Diabeteszentrum NRW
    Bad Oeynhausen, 32545, Germany
  • Universitätsklinikum Köln
    Cologne, 50937, Germany
  • St.-Johannes-Hospital Dortmund
    Dortmund, 44137, Germany
  • Universitätsklinikum Gießen
    Giessen, 35392, Germany
  • Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
    Leipzig, 04289, Germany
  • Herzzentrum München
    München, 80636, Germany
  • LMU Klinikum München
    München, 81377, Germany
  • Universitätsklinikum Tübingen
    Tübingen, 72076, Germany
  • Helios Klinikum Wuppertal
    Wuppertal, 42283, Germany
08

References and documents

Publications

  • Feistritzer HJ, Ender J, Lauten P, Rudolph TK, Rudolph V, Geisler T, Massberg S, Adam M, Baldus S, Sossalla S, Joner M, Mollmann H, Wolf A, Kim WK, Borger MA, Noack T, Magunia H, von Dossow V, Sander M, Vigelius-Rauch U, Feuerecker M, Zakhary W, Boening A, Bleiziffer S, Hohenstein S, Hoesler N, Buske M, Desch S, Abdel-Wahab M, Thiele H; DOUBLE-CHOICE Investigators. Peri-Interventional Anesthesia Strategies for Transcatheter Aortic Valve Implantation: A Multicenter, Randomized, Controlled, Noninferiority Trial. Circulation. 2025 Dec 2;152(22):1526-1537. doi: 10.1161/CIRCULATIONAHA.125.076557. Epub 2025 Aug 29. PubMed 40878766 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05036018
Lead sponsor
Leipzig Heart Science gGmbH
Collaborators
Heart Center Leipzig - University Hospital
Responsible party
Sponsor
First posted
Sep 5, 2021
Start date
Aug 30, 2021
Primary completion
Mar 31, 2025
Completion
Feb 1, 2035 (estimated)
Last update
Feb 11, 2026

Study contacts

Holger Thiele, Prof. Dr.
study chair · Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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