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

NCT ID: NCT05036018

Last Updated: 2026-02-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 836 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-30
• Study Completion Date: 2035-02-01

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, 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.

Conditions

Aortic Valve Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Patients treated with the ACURATE neo2 valve using a minimalist approach

Group Type: ACTIVE_COMPARATOR

ACURATE neo2

Intervention Type: 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

Intervention Type: 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.

Group 2

Patients treated with the ACURATE neo2 valve under standard of care

Group Type: ACTIVE_COMPARATOR

ACURATE neo2

Intervention Type: 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.

Standard of care

Intervention Type: 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.

Group 3

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

Group Type: ACTIVE_COMPARATOR

minimalist approach

Intervention Type: 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

Intervention Type: 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.

Group 4

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

Group Type: ACTIVE_COMPARATOR

CoreValve Evolut Pro, Pro+ and FX

Intervention Type: 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

Intervention Type: 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.

Interventions

ACURATE 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.

Intervention Type: DEVICE

minimalist 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.

Intervention Type: PROCEDURE

CoreValve 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.

Intervention Type: DEVICE

Standard 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart Center Leipzig - University Hospital

OTHER

Sponsor Role: collaborator

Leipzig Heart Science gGmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Holger Thiele, Prof. Dr.

Role: STUDY_CHAIR

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

Locations

Zentralklinik Bad Berka

Bad Berka, , Germany

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, , Germany

Universitätsklinikum Köln

Cologne, , 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

Herzzentrum München

München, , Germany

LMU Klinikum München

München, , Germany

Universitätsklinikum Tübingen

Tübingen, , Germany

Helios Klinikum Wuppertal

Wuppertal, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 40878766 (View on PubMed)

Other Identifiers

2021-0165

Identifier Type: -

Identifier Source: org_study_id