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

Aortic Valve Stenosis Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05036018
• Other study ID #: 2021-0165
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2021
• Est. completion date: October 31, 2033

Study information

• Verified date: March 2023
• Source: Leipzig Heart Science gGmbH
• Contact: Holger Thiele, Prof. Dr.
• Phone: 0049 341 865
• Email: holger.thiele[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 836
• Est. completion date: October 31, 2033
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

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.

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.

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.

Locations

Country	Name	City	State
Germany	Zentralklinik Bad Berka	Bad Berka
Germany	Herz- und Diabeteszentrum NRW	Bad Oeynhausen
Germany	Segeberger Kliniken GmbH	Bad Segeberg
Germany	St.-Johannes-Hospital Dortmund	Dortmund
Germany	Universitätsklinikum Gießen	Gießen
Germany	Universitätsklinikum Köln	Köln
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

Sponsors (2)

Lead Sponsor	Collaborator
Leipzig Heart Science gGmbH	Heart Center Leipzig - University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Devices: Composite of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30-day follow-up		Day 30
Primary	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)		Day 30