Clinical trial NCT05036018: RanDOmized stUdy Comparing Both Latest Generation Self-Expanding Valves and a Minimalist approaCH vs. Standard Of Care In transCathEter Aortic Valve Implantation
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: TAVI
ACURATE neo2
Evolut Pro
local anesthesia
conscious sedation
monitored anesthesia care
minimalist approach
Lead sponsor: Leipzig Heart Science gGmbH
Sponsor class: OTHER
Collaborators: name: Heart Center Leipzig - University Hospital
First posted: 2021-09-05
Enrollment: 836
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Patients will be randomized to one of four treatment groups in a 1:1:1:1 ratio
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Devices: Composite of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30-day follow-up
timeFrame: Day 30
measure: 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)
timeFrame: Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
city: Dortmund
country: Germany
facility: St.-Johannes-Hospital Dortmund
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen
city: Köln
country: Germany
facility: Universitätsklinikum Köln
city: Leipzig
country: Germany
facility: Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
city: München
country: Germany
facility: Herzzentrum München
city: München
country: Germany
facility: LMU Klinikum München
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Wuppertal
country: Germany
facility: Helios Klinikum Wuppertal
Study officials:
affiliation: Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
name: Holger Thiele, Prof. Dr.
role: STUDY_CHAIR
References: