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

Primary Purpose

Aortic Valve Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ACURATE neo2
minimalist approach
CoreValve Evolut Pro and Pro+
Standard of care
Sponsored by
Leipzig Heart Science gGmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring TAVI, ACURATE neo2, Evolut Pro, local anesthesia, conscious sedation, monitored anesthesia care, minimalist approach

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zentralklinik Bad BerkaRecruiting
  • Herz- und Diabeteszentrum NRWRecruiting
  • Segeberger Kliniken GmbH
  • St.-Johannes-Hospital DortmundRecruiting
  • Universitätsklinikum GießenRecruiting
  • Universitätsklinikum KölnRecruiting
  • Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/CardiologyRecruiting
  • Herzzentrum München
  • LMU Klinikum MünchenRecruiting
  • Universitätsklinikum TübingenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

Patients treated with the ACURATE neo2 valve using a minimalist approach

Patients treated with the ACURATE neo2 valve under standard of care

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 30, 2021
Last Updated
July 4, 2023
Sponsor
Leipzig Heart Science gGmbH
Collaborators
Heart Center Leipzig - University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05036018
Brief Title
RanDOmized stUdy Comparing Both Latest Generation Self-Expanding Valves and a Minimalist approaCH vs. Standard Of Care In transCathEter Aortic Valve Implantation
Acronym
DOUBLE-CHOICE
Official Title
RanDOmized stUdy Comparing Both Latest Generation Self-Expanding Valves and a Minimalist approaCH vs. Standard Of Care In transCathEter Aortic Valve Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
October 31, 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Leipzig Heart Science gGmbH
Collaborators
Heart Center Leipzig - University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis
Keywords
TAVI, ACURATE neo2, Evolut Pro, local anesthesia, conscious sedation, monitored anesthesia care, minimalist approach

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Patients will be randomized to one of four treatment groups in a 1:1:1:1 ratio
Masking
None (Open Label)
Masking Description
Blinding of cardiologists, anesthesiologists and patients is not possible due to the type of interventions.
Allocation
Randomized
Enrollment
836 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Patients treated with the ACURATE neo2 valve using a minimalist approach
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Patients treated with the ACURATE neo2 valve under standard of care
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
Patients treated with the Evolut Pro or Pro+ valve using a minimalist approach
Arm Title
Group 4
Arm Type
Active Comparator
Arm Description
Patients treated with the Evolut Pro or Pro+ valve under standard of care
Intervention Type
Device
Intervention Name(s)
ACURATE neo2
Intervention Description
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
Procedure
Intervention Name(s)
minimalist approach
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
CoreValve Evolut Pro and Pro+
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard of care
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Holger Thiele, Prof. Dr.
Phone
0049 341 865
Ext
1427
Email
holger.thiele@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Abdel-Wahab, Prof. Dr.
Email
mohamed.abdel-wahab@medizin.uni-leipzig.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holger Thiele, Prof. Dr.
Organizational Affiliation
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
Official's Role
Study Chair
Facility Information:
Facility Name
Zentralklinik Bad Berka
City
Bad Berka
ZIP/Postal Code
99437
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philipp Lauten, Dr. med.
First Name & Middle Initial & Last Name & Degree
Harald Lapp, Prof. Dr.
Facility Name
Herz- und Diabeteszentrum NRW
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tanja Rudolph, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Sabine Bleiziffer, Prof. Dr.
Facility Name
Segeberger Kliniken GmbH
City
Bad Segeberg
ZIP/Postal Code
23795
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Landt, MD
Facility Name
St.-Johannes-Hospital Dortmund
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helge Möllmann, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Vedat Tiyerili, Dr.
Facility Name
Universitätsklinikum Gießen
City
Gießen
ZIP/Postal Code
35392
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holger Nef, Prof. Dr
First Name & Middle Initial & Last Name & Degree
Oliver Dörr, Prof. Dr.
Facility Name
Universitätsklinikum Köln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matti Adam, PD Dr.
Facility Name
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holger Thiele, Prof. Dr.
Email
holger.thiele@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name & Degree
Mohamed Abdel-Wahab, Prof. Dr.
Email
mohamed.abdel-wahab@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name & Degree
Hans-Josef Feistritzer, Dr.
Facility Name
Herzzentrum München
City
München
ZIP/Postal Code
80636
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Joner, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Erion Xhepa, PD Dr.
Facility Name
LMU Klinikum München
City
München
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steffen Massberg, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Martin Orban, PD Dr.
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias Geisler, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Michal Droppa, PD Dr.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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