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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
836
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.
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.
Zentralklinik Bad Berka
Bad Berka, Germany
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany
Universitätsklinikum Köln
Cologne, Germany
St.-Johannes-Hospital Dortmund
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
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.
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