Aortic Valve Stenosis
Conditions
Keywords
TAVI, ACURATE neo2, Evolut Pro, local anesthesia, conscious sedation, monitored anesthesia care, minimalist approach
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.
Interventions
DEVICEACURATE 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.
PROCEDUREminimalist 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. Patients will be directly transferred to the cardiology ward after the procedure, which can be postponed in case of complications.
DEVICECoreValve Evolut Pro, Pro+ and FX
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.
PROCEDUREStandard 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%. The use of central venous catheters, additional arterial lines for blood pressure monitoring, and urinary catheters can be implemented according to local institutional standards.
Sponsors
Leipzig Heart Science gGmbH
Heart Center Leipzig - University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Blinding of cardiologists, anesthesiologists and patients is not possible due to the type of interventions.
Intervention model description
Patients will be randomized to one of four treatment groups in a 1:1:1:1 ratio
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
Germany
Contacts
STUDY_CHAIRHolger Thiele, Prof. Dr.
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
Outcome results
None listed