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
Status: Recruiting
Location: See all (49) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 75
Healthy Volunteers: f
View:
⁃ Participant will be included if all the following criteria are met:
• Patients aged ≥65 and ≤75
• Symptomatic severe aortic stenosis (mean gradient≥40mmHg, and or peak velocity\>4m/sec).
• Patients with symptomatic heart disease due to severe native calcific aortic stenosis, as judged by a multidisciplinary heart team (including a cardiac surgeon), for whom SAVR or transfemoral TAVR is deemed feasible and approved by the local heart team.Signed informed consent for participation in the clinical investigation
Locations
Other Locations
Austria
Medical University of Graz
RECRUITING
Graz
University Hostpital Sankt Pölten
RECRUITING
Sankt Pölten
Medical University of Vienna
RECRUITING
Vienna
Estonia
North-Estonia Medical Centre Foundation
RECRUITING
Tallinn
France
CHU Lille
RECRUITING
Lille
Infirmerie Protestante de Lyon
RECRUITING
Lyon
Massy-Hôpital Jacques Cartier
RECRUITING
Massy
CHU de Rouen
NOT_YET_RECRUITING
Rouen
Clinique Pasteur
RECRUITING
Toulouse
Germany
University Hospital Frankfurt
NOT_YET_RECRUITING
Frankfurt
Universitätsklinikum Hamburg-Eppendorf
NOT_YET_RECRUITING
Hamburg
German Heart Munich
NOT_YET_RECRUITING
München
Krankenhaus der Barmherzigen Brüder Trier
NOT_YET_RECRUITING
Trier
Hungary
Gottsegen National Cardiovascular Center
NOT_YET_RECRUITING
Budapest
Department of Cardiology and Cardiac Surgery, University of Debrecen
NOT_YET_RECRUITING
Debrecen
University of Szeged
NOT_YET_RECRUITING
Szeged
Italy
Montevergine Clinic
NOT_YET_RECRUITING
Mercogliano
Centro Cardiologico Monzino IRCCS
NOT_YET_RECRUITING
Milan
IRCCS Ospedale Galeazzi Sant'Ambrogio
NOT_YET_RECRUITING
Milan
Azienda Ospedaliero-Universitaria di Parma
NOT_YET_RECRUITING
Parma
Fondazione Policlinico Campus Bio-Medico di Roma
NOT_YET_RECRUITING
Roma
IRCCS Policlinico San Donato
NOT_YET_RECRUITING
San Donato Milanese
Poland
Poznan University Hospital
NOT_YET_RECRUITING
Poznan
Pomorski Uniwersytet Medyczny w Szczecinie
NOT_YET_RECRUITING
Szczecin
Medical Univeristy of Warsaw
NOT_YET_RECRUITING
Warsaw
Military Institute of Medicine in Warsaw
NOT_YET_RECRUITING
Warsaw
National Institute of Cardiology
NOT_YET_RECRUITING
Warsaw
Military Hospital in Wroclaw
NOT_YET_RECRUITING
Wroclaw
Provincial Specialist Hospital in Wroclaw
NOT_YET_RECRUITING
Wroclaw
Portugal
Hospital de Santa Cruz, ULSLO
RECRUITING
Carnaxide
Romania
Bucharest Clinical Emergency Hospital
NOT_YET_RECRUITING
Bucharest
Central military emergency university hospital
NOT_YET_RECRUITING
Bucharest
IBCV Iasi
NOT_YET_RECRUITING
Iași
Serbia
University Clinical Center of Serbia
NOT_YET_RECRUITING
Belgrade
Institute of Cardiovascular Diseases of Vojvodina
RECRUITING
Kamenitz
Slovenia
UKC Ljubljana
RECRUITING
Ljubljana
Spain
Hospital Universitario Central de Asturias
RECRUITING
Oviedo
Hospital clínico universitario de Valladolid
RECRUITING
Valladolid
Switzerland
CHUV
RECRUITING
Lausanne
United Kingdom
Royal Victoria Hospital
NOT_YET_RECRUITING
Belfast
University Hospital Sussex NHS foundation Trust
RECRUITING
Brighton
Royal Papworth Hospital
NOT_YET_RECRUITING
Cambridge
Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust
RECRUITING
Cottingham
University Hospitals Coventry and Warwickshire NHS Trust
RECRUITING
Coventry
Barts Heart Centre
RECRUITING
London
Imperial College Healthcare NHS Trust
RECRUITING
London
Freeman Hospital
NOT_YET_RECRUITING
Newcastle Upon Tyne
Sheffield Teaching Hopitals NHS Foundation Trust
NOT_YET_RECRUITING
Sheffield
Morriston Hospital
RECRUITING
Swansea
Contact Information
Primary
Philippe Garot, MD
pgarot@angio-icps.com
+330160134602
Backup
Marie-Claude Morrice, MD
mcmorice@cerc-europe.org
Time Frame
Start Date: 2025-05-15
Estimated Completion Date: 2037-09
Participants
Target number of participants: 1180
Treatments
Experimental: TAVR: Myval balloon-expandable THV Series
Myval balloon-expandable THV Series will be used for valve replacement
Active_comparator: SAVR: Any surgical bioprosthetic valve commercially available at the clinical investigation site
Surgical bioprosthetic valve commercially available at the clinical investigation site will be used for valve replacement
Related Therapeutic Areas
Sponsors
Leads: Ceric Sàrl
Collaborators: European Cardiovascular Research Center