Phase
Condition
N/ATreatment
minimalist approach
ACURATE neo2
CoreValve Evolut Pro and Pro+
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Severe symptomatic aortic valve stenosis (AVA ≤1 cm² or 0.6 cm²/m²) with indicationfor 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
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 valvetype over the other
Active infection requiring antibiotic treatment
Age <18 years
Participation in another interventional trial where the primary endpoint has notbeen reached
Study Design
Study Description
Connect with a study center
Zentralklinik Bad Berka
Bad Berka, 99437
GermanySite Not Available
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, 32545
GermanySite Not Available
Segeberger Kliniken GmbH
Bad Segeberg, 23795
GermanySite Not Available
St.-Johannes-Hospital Dortmund
Dortmund, 44137
GermanySite Not Available
Universitätsklinikum Gießen
Gießen, 35392
GermanySite Not Available
Universitätsklinikum Köln
Köln, 50937
GermanySite Not Available
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
Leipzig, 04289
GermanySite Not Available
Herzzentrum München
München, 80636
GermanySite Not Available
LMU Klinikum München
München, 81377
GermanySite Not Available
Universitätsklinikum Tübingen
Tübingen, 72076
GermanySite Not Available
Helios Klinikum Wuppertal
Wuppertal, 42283
GermanySite Not Available
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