RecruitingNot ApplicableNCT06861361

Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients

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

Sponsor

Ceric Sàrl

Enrollment

1,180 participants

Start Date

May 15, 2025

Study Type

INTERVENTIONAL

Conditions

Symptomatic Severe Aortic Stenosis

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

Min Age: 65 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Myval balloon-expandable THV Series and a medical device called Surgical bioprosthetic valve for people with symptomatic severe aortic stenosis. The study is currently recruiting participants at 49 locations. People eligible for this study include aged 65 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEMyval balloon-expandable THV Series

Patients receive Myval balloon-expandable THV Series (TAVR)

DEVICESurgical 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06861361

Related Trials

Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation

NCT0478888839 locations