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

Sponsor

Leipzig Heart Science gGmbH (Other)

Overall Status

Recruiting

CT.gov ID

NCT05036018

Collaborator

Heart Center Leipzig - University Hospital (Other)

836

Enrollment

Locations

Arms

134

Anticipated Duration (Months)

104.5

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis	Device: ACURATE neo2 Procedure: minimalist approach Device: CoreValve Evolut Pro and Pro+ Procedure: Standard of care	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

836 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

Patients will be randomized to one of four treatment groups in a 1:1:1:1 ratioPatients 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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 30, 2021

Anticipated Primary Completion Date :

Nov 30, 2022

Anticipated Study Completion Date :

Oct 31, 2032

Arms and Interventions

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	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.

Outcome Measures

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 [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) [Day 30]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Zentralklinik Bad Berka	Bad Berka	Germany	99437
2	Herz- und Diabeteszentrum NRW	Bad Oeynhausen	Germany	32545
3	St.-Johannes-Hospital Dortmund	Dortmund	Germany	44137
4	Universitätsklinikum Gießen	Gießen	Germany	35392
5	Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology	Leipzig	Germany	04289
6	Herzzentrum München	München	Germany	80636
7	LMU Klinikum München	München	Germany	81377
8	Universitätsklinikum Tübingen	Tübingen	Germany	72076