Actively Recruiting
Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients
Led by Ceric Sàrl · Updated on 2026-05-12
1180
Participants Needed
49
Research Sites
641 weeks
Total Duration
On this page
Sponsors
C
Ceric Sàrl
Lead Sponsor
E
European Cardiovascular Research Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 65 to 75 years
- Symptomatic severe aortic stenosis with mean gradient ≥40 mmHg or peak velocity >4 m/sec
- Symptomatic heart disease due to severe native calcific aortic stenosis judged eligible for SAVR or transfemoral TAVR by a multidisciplinary heart team
- Signed informed consent for participation in the clinical investigation
You will not qualify if you...
- Unable to understand or follow clinical investigation instructions or protocol
- Life expectancy less than 1 year
- Known allergy to aspirin, clopidogrel, or any device frame components
- Under judicial protection, tutorship, or curatorship
- Participation in another trial before the primary endpoint
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 49 locations
1
Medical University of Graz
Graz, Austria, 8036
Actively Recruiting
2
University Hostpital Sankt Pölten
Sankt Pölten, Austria, 3100
Actively Recruiting
3
Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
4
North-Estonia Medical Centre Foundation
Tallinn, Estonia, 13419
Actively Recruiting
5
CHU Lille
Lille, France
Actively Recruiting
6
Infirmerie Protestante de Lyon
Lyon, France
Actively Recruiting
7
Massy-Hôpital Jacques Cartier
Massy, France
Actively Recruiting
8
CHU de Rouen
Rouen, France
Not Yet Recruiting
9
Clinique Pasteur
Toulouse, France
Actively Recruiting
10
University Hospital Frankfurt
Frankfurt, Germany, 60596
Not Yet Recruiting
11
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Not Yet Recruiting
12
German Heart Munich
München, Germany, 80636
Not Yet Recruiting
13
Krankenhaus der Barmherzigen Brüder Trier
Trier, Germany, 54292
Not Yet Recruiting
14
Gottsegen National Cardiovascular Center
Budapest, Hungary
Not Yet Recruiting
15
Department of Cardiology and Cardiac Surgery, University of Debrecen
Debrecen, Hungary
Not Yet Recruiting
16
University of Szeged
Szeged, Hungary
Not Yet Recruiting
17
Montevergine Clinic
Mercogliano, Italy, 83013
Not Yet Recruiting
18
IRCCS Ospedale Galeazzi Sant'Ambrogio
Milan, Italy, 20157
Not Yet Recruiting
19
Centro Cardiologico Monzino IRCCS
Milan, Italy
Not Yet Recruiting
20
Azienda Ospedaliero-Universitaria di Parma
Parma, Italy, 43126
Not Yet Recruiting
21
Fondazione Policlinico Campus Bio-Medico di Roma
Roma, Italy, 00128
Not Yet Recruiting
22
IRCCS Policlinico San Donato
San Donato Milanese, Italy, 20097
Not Yet Recruiting
23
Poznan University Hospital
Poznan, Poland, 61848
Not Yet Recruiting
24
Pomorski Uniwersytet Medyczny w Szczecinie
Szczecin, Poland, 70111
Not Yet Recruiting
25
Medical Univeristy of Warsaw
Warsaw, Poland, 02097
Not Yet Recruiting
26
National Institute of Cardiology
Warsaw, Poland, 04628
Not Yet Recruiting
27
Military Institute of Medicine in Warsaw
Warsaw, Poland
Not Yet Recruiting
28
Military Hospital in Wroclaw
Wroclaw, Poland, 50981
Not Yet Recruiting
29
Provincial Specialist Hospital in Wroclaw
Wroclaw, Poland
Not Yet Recruiting
30
Hospital de Santa Cruz, ULSLO
Carnaxide, Portugal
Actively Recruiting
31
Bucharest Clinical Emergency Hospital
Bucharest, Romania
Not Yet Recruiting
32
Central military emergency university hospital
Bucharest, Romania
Not Yet Recruiting
33
IBCV Iasi
Iași, Romania
Not Yet Recruiting
34
University Clinical Center of Serbia
Belgrade, Serbia
Not Yet Recruiting
35
Institute of Cardiovascular Diseases of Vojvodina
Kamenitz, Serbia
Actively Recruiting
36
UKC Ljubljana
Ljubljana, Slovenia, 1000
Actively Recruiting
37
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain, 33011
Actively Recruiting
38
Hospital clínico universitario de Valladolid
Valladolid, Spain
Actively Recruiting
39
CHUV
Lausanne, Switzerland
Actively Recruiting
40
Royal Victoria Hospital
Belfast, United Kingdom
Not Yet Recruiting
41
University Hospital Sussex NHS foundation Trust
Brighton, United Kingdom
Actively Recruiting
42
Royal Papworth Hospital
Cambridge, United Kingdom
Not Yet Recruiting
43
Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust
Cottingham, United Kingdom
Actively Recruiting
44
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, United Kingdom
Actively Recruiting
45
Barts Heart Centre
London, United Kingdom
Actively Recruiting
46
Imperial College Healthcare NHS Trust
London, United Kingdom
Actively Recruiting
47
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Not Yet Recruiting
48
Sheffield Teaching Hopitals NHS Foundation Trust
Sheffield, United Kingdom
Not Yet Recruiting
49
Morriston Hospital
Swansea, United Kingdom
Actively Recruiting
Research Team
P
Philippe Garot, MD
CONTACT
M
Marie-Claude Morrice, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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