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Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients
Sponsor: Ceric Sàrl
Summary
The study objective is to demonstrate that the clinical outcomes of the Myval balloon-expandable THV series are non-inferior to those of SAVR in patients with symptomatic severe aortic stenosis aged 65 to 75 years.
Official title: Surgical Bioprosthesis Aortic Valve Replacement Vs. Myval Balloon-Expandable THV Series in Patients Aged 65 to 75 With Symptomatic Severe Aortic Stenosis Judged Eligible by Heart Team
Key Details
Gender
All
Age Range
65 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
1180
Start Date
2025-05-15
Completion Date
2037-09
Last Updated
2026-05-12
Healthy Volunteers
No
Conditions
Interventions
Myval balloon-expandable THV Series
Patients receive Myval balloon-expandable THV Series (TAVR)
Surgical bioprosthetic valve
Patients receive any surgical bioprosthetic valve commercially available at the clinical investigation site (SAVR)
Locations (49)
Medical University of Graz
Graz, Austria
University Hostpital Sankt Pölten
Sankt Pölten, Austria
Medical University of Vienna
Vienna, Austria
North-Estonia Medical Centre Foundation
Tallinn, Estonia
CHU Lille
Lille, France
Infirmerie Protestante de Lyon
Lyon, France
Massy-Hôpital Jacques Cartier
Massy, France
CHU de Rouen
Rouen, France
Clinique Pasteur
Toulouse, France
University Hospital Frankfurt
Frankfurt, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
German Heart Munich
München, Germany
Krankenhaus der Barmherzigen Brüder Trier
Trier, Germany
Gottsegen National Cardiovascular Center
Budapest, Hungary
Department of Cardiology and Cardiac Surgery, University of Debrecen
Debrecen, Hungary
University of Szeged
Szeged, Hungary
Montevergine Clinic
Mercogliano, Italy
IRCCS Ospedale Galeazzi Sant'Ambrogio
Milan, Italy
Centro Cardiologico Monzino IRCCS
Milan, Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, Italy
Fondazione Policlinico Campus Bio-Medico di Roma
Roma, Italy
IRCCS Policlinico San Donato
San Donato Milanese, Italy
Poznan University Hospital
Poznan, Poland
Pomorski Uniwersytet Medyczny w Szczecinie
Szczecin, Poland
Medical Univeristy of Warsaw
Warsaw, Poland
National Institute of Cardiology
Warsaw, Poland
Military Institute of Medicine in Warsaw
Warsaw, Poland
Military Hospital in Wroclaw
Wroclaw, Poland
Provincial Specialist Hospital in Wroclaw
Wroclaw, Poland
Hospital de Santa Cruz, ULSLO
Carnaxide, Portugal
Bucharest Clinical Emergency Hospital
Bucharest, Romania
Central military emergency university hospital
Bucharest, Romania
IBCV Iasi
Iași, Romania
University Clinical Center of Serbia
Belgrade, Serbia
Institute of Cardiovascular Diseases of Vojvodina
Kamenitz, Serbia
UKC Ljubljana
Ljubljana, Slovenia
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital clínico universitario de Valladolid
Valladolid, Spain
CHUV
Lausanne, Switzerland
Royal Victoria Hospital
Belfast, United Kingdom
University Hospital Sussex NHS foundation Trust
Brighton, United Kingdom
Royal Papworth Hospital
Cambridge, United Kingdom
Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust
Cottingham, United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, United Kingdom
Barts Heart Centre
London, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Sheffield Teaching Hopitals NHS Foundation Trust
Sheffield, United Kingdom
Morriston Hospital
Swansea, United Kingdom