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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: ACURATE neo2
* Procedure: minimalist approach
* Device: CoreValve Evolut Pro and Pro+
* Procedure: Standard of care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Patients will be randomized to one of four treatment groups in a 1:1:1:1 ratio
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Patients treated with the ACURATE neo2 valve using a minimalist approach | Device: ACURATE neo2<br>* 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.<br>Procedure: minimalist approach<br>* 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.<br>|
| Active Comparator: Group 2<br>Patients treated with the ACURATE neo2 valve under standard of care | Device: ACURATE neo2<br>* 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.<br>Procedure: Standard of care<br>* 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.<br>|
| Active Comparator: Group 3<br>Patients treated with the Evolut Pro or Pro+ valve using a minimalist approach | Procedure: minimalist approach<br>* 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.<br>Device: CoreValve Evolut Pro and Pro+<br>* 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.<br>|
| Active Comparator: Group 4<br>Patients treated with the Evolut Pro or Pro+ valve under standard of care | Device: CoreValve Evolut Pro and Pro+<br>* 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.<br>Procedure: Standard of care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVI, ACURATE neo2, Evolut Pro, local anesthesia, conscious sedation, monitored anesthesia care, minimalist approach