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Clinical Trials in France / NCT06861361
Recruiting Not applicable

Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients

NCT06861361 · tracked via the Priya Life Science France tracker
Sponsor
Ceric Sàrl
Phase
Not applicable
Started
2025-05-15
Last updated
2026-05-12

Condition(s) studied

Symptomatic Severe Aortic Stenosis

Investigational drug(s) / intervention(s)

Myval balloon-expandable THV SeriesSurgical bioprosthetic valve

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)

Study 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

Sex
ALL
Min age
65 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: Participant will be included if all the following criteria are met: 1. Patients aged ≥65 and ≤75 2. Symptomatic severe aortic stenosis (mean gradient≥40mmHg, and or peak velocity\>4m/sec). 3. 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 Exclusion Criteria: Participant will not be included if any one of the following conditions exists: 1. Unable to understand and follow clinical investigation-related instructions or unable to comply with the clinical investigation protocol 2. Life expectancy less than 1 year 3. Known hypersensitivity or allergy to aspirin, clopidogrel or any Device frame components. 4. Under judicial protection, tutorship, or curatorship 5. Participation in another trial before the primary endpoint

Primary outcome measure(s)

  • Primary safety endpoint at 1 month (non-inferiority): Composite measure of all-cause death, any stroke, bleeding, AKI stage 2-4, rehospitalization for a procedure-related event or or reintervention for aortic valve dysfunction. — 1 month post procedure
    Composite measure of all-cause death, any stroke, VARC-3 type 1 (only overt bleeding that requires a transfusion of 1 unit of whole blood/red blood cells (BARC 3a), type 2 and 3 bleeding, AKI stage 2-4, rehospitalization for a procedure-related event or reintervention for aortic valve dysfunction.
  • Primary efficacy endpoint at 1 year (non-inferiority): Composite measure of all-cause death, any stroke, or rehospitalization for valve related event — 1 year post procedure
    Composite measure of all-cause death, any stroke, or rehospitalization for valve related event at 1 year (VARC-3 definition)
  • CT Scan Sub Study endpoints: primary endpoint : prevalence of feasible redoTAVR or ViV TAVR without requiring leaflet modifications techniques (green cases). — 1 month post procedure
    Proportion of participants classified as "green cases" (redo-TAVR or ViV-TAVR feasible without leaflet modification) based on predefined CT scan criteria, including annular dimensions, coronary access, and valve frame interactions.

Trial sites (49)

FacilityCityRegionStatus
Medical University of Graz Graz Austria Recruiting
University Hostpital Sankt Pölten Sankt Pölten Austria Recruiting
Medical University of Vienna Vienna Austria Recruiting
North-Estonia Medical Centre Foundation Tallinn Estonia Recruiting
CHU Lille Lille France Recruiting
Infirmerie Protestante de Lyon Lyon France Recruiting
Massy-Hôpital Jacques Cartier Massy France Recruiting
CHU de Rouen Rouen France Not Yet Recruiting
Clinique Pasteur Toulouse France Recruiting
University Hospital Frankfurt Frankfurt Germany Not Yet Recruiting
Universitätsklinikum Hamburg-Eppendorf Hamburg Germany Not Yet Recruiting
German Heart Munich München Germany Not Yet Recruiting
Krankenhaus der Barmherzigen Brüder Trier Trier Germany Not Yet Recruiting
Gottsegen National Cardiovascular Center Budapest Hungary Not Yet Recruiting
Department of Cardiology and Cardiac Surgery, University of Debrecen Debrecen Hungary Not Yet Recruiting
University of Szeged Szeged Hungary Not Yet Recruiting
Montevergine Clinic Mercogliano Italy Not Yet Recruiting
IRCCS Ospedale Galeazzi Sant'Ambrogio Milan Italy Not Yet Recruiting
Centro Cardiologico Monzino IRCCS Milan Italy Not Yet Recruiting
Azienda Ospedaliero-Universitaria di Parma Parma Italy Not Yet Recruiting
Fondazione Policlinico Campus Bio-Medico di Roma Roma Italy Not Yet Recruiting
IRCCS Policlinico San Donato San Donato Milanese Italy Not Yet Recruiting
Poznan University Hospital Poznan Poland Not Yet Recruiting
Pomorski Uniwersytet Medyczny w Szczecinie Szczecin Poland Not Yet Recruiting
Medical Univeristy of Warsaw Warsaw Poland Not Yet Recruiting
National Institute of Cardiology Warsaw Poland Not Yet Recruiting
Military Institute of Medicine in Warsaw Warsaw Poland Not Yet Recruiting
Military Hospital in Wroclaw Wroclaw Poland Not Yet Recruiting
Provincial Specialist Hospital in Wroclaw Wroclaw Poland Not Yet Recruiting
Hospital de Santa Cruz, ULSLO Carnaxide Portugal Recruiting
Bucharest Clinical Emergency Hospital Bucharest Romania Not Yet Recruiting
Central military emergency university hospital Bucharest Romania Not Yet Recruiting
IBCV Iasi Iași Romania Not Yet Recruiting
University Clinical Center of Serbia Belgrade Serbia Not Yet Recruiting
Institute of Cardiovascular Diseases of Vojvodina Kamenitz Serbia Recruiting
UKC Ljubljana Ljubljana Slovenia Recruiting
Hospital Universitario Central de Asturias Oviedo Principality of Asturias Recruiting
Hospital clínico universitario de Valladolid Valladolid Spain Recruiting
CHUV Lausanne Switzerland Recruiting
Royal Victoria Hospital Belfast United Kingdom Not Yet Recruiting

+ 9 more sites — see the full list on the official registry below.

More Ceric Sàrl trials in France

Evaluation of the Valiant Captivia Physician Fenestrated Stent Graft System in Aortic Arch and Descending Thoracic Aorta Pathologies Recruiting

Other trials for the same condition

Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis Active, not recruiting
Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06861361 on ClinicalTrials.gov ↗ ← All trials in France