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

July 4, 2023 updated by: Leipzig Heart Science gGmbH
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

836

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Bad Berka, Germany, 99437
        • Recruiting
        • Zentralklinik Bad Berka
        • Contact:
          • Philipp Lauten, Dr. med.
        • Contact:
          • Harald Lapp, Prof. Dr.
      • Bad Oeynhausen, Germany, 32545
        • Recruiting
        • Herz- und Diabeteszentrum NRW
        • Contact:
          • Tanja Rudolph, Prof. Dr.
        • Contact:
          • Sabine Bleiziffer, Prof. Dr.
      • Bad Segeberg, Germany, 23795
        • Not yet recruiting
        • Segeberger Kliniken Gmbh
        • Contact:
          • Martin Landt, MD
      • Dortmund, Germany, 44137
        • Recruiting
        • St.-Johannes-Hospital Dortmund
        • Contact:
          • Helge Möllmann, Prof. Dr.
        • Contact:
          • Vedat Tiyerili, Dr.
      • Gießen, Germany, 35392
        • Recruiting
        • Universitätsklinikum Gießen
        • Contact:
          • Holger Nef, Prof. Dr
        • Contact:
          • Oliver Dörr, Prof. Dr.
      • Köln, Germany, 50937
        • Recruiting
        • Universitätsklinikum Köln
        • Contact:
          • Matti Adam, PD Dr.
      • Leipzig, Germany, 04289
      • München, Germany, 80636
        • Not yet recruiting
        • Herzzentrum München
        • Contact:
          • Michael Joner, Prof. Dr.
        • Contact:
          • Erion Xhepa, PD Dr.
      • München, Germany, 81377
        • Recruiting
        • LMU Klinikum München
        • Contact:
          • Steffen Massberg, Prof. Dr.
        • Contact:
          • Martin Orban, PD Dr.
      • Tübingen, Germany, 72076
        • Recruiting
        • Universitätsklinikum Tübingen
        • Contact:
          • Tobias Geisler, Prof. Dr.
        • Contact:
          • Michal Droppa, PD Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Patients treated with the ACURATE neo2 valve using a minimalist approach
Device: 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.
Procedure: 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. Presence of an anesthesiologist is optional. Patients will be directly transferred to the cardiology ward after the procedure, which can be postponed in case of complications.
Active Comparator: Group 2
Patients treated with the ACURATE neo2 valve under standard of care
Device: 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.
Procedure: 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%. Presence of an anesthesiologist is obligatory. The use of central venous catheters, additional arterial lines for blood pressure monitoring, and urinary catheters can be implemented according to local institutional standards.
Active Comparator: Group 3
Patients treated with the Evolut Pro or Pro+ valve using a minimalist approach
Procedure: 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. Presence of an anesthesiologist is optional. Patients will be directly transferred to the cardiology ward after the procedure, which can be postponed in case of complications.
Device: CoreValve Evolut Pro and Pro+
The Evolut Pro or Pro+ 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.
Active Comparator: Group 4
Patients treated with the Evolut Pro or Pro+ valve under standard of care
Procedure: 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%. Presence of an anesthesiologist is obligatory. The use of central venous catheters, additional arterial lines for blood pressure monitoring, and urinary catheters can be implemented according to local institutional standards.
Device: CoreValve Evolut Pro and Pro+
The Evolut Pro or Pro+ 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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)
Time Frame: Day 30
Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leipzig Heart Science gGmbH

Collaborators

Heart Center Leipzig - University Hospital

Investigators

  • Study Chair: Holger Thiele, Prof. Dr., Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

October 31, 2033

Study Registration Dates

First Submitted

August 30, 2021

First Submitted That Met QC Criteria

August 30, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

July 6, 2023

Last Update Submitted That Met QC Criteria

July 4, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0165

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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