Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients

NCT06861361 | Recruiting DMC

• 1 other identifier: START YOUNG
• Study Type: interventional
• Target: 1,180
• Locations: 13 countries
• Sites: 48

Brief 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.

Conditions

Symptomatic Severe Aortic Stenosis

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  1 month post procedure

• Primary efficacy endpoint at 1 year (non-inferiority): Composite measure of all-cause death, any stroke, or rehospitalization for valve related event

  Composite measure of all-cause death, any stroke, or rehospitalization for valve related event at 1 year (VARC-3 definition)

  1 year post procedure

• CT Scan Sub Study endpoints: primary endpoint : prevalence of feasible redoTAVR or ViV TAVR without requiring leaflet modifications techniques (green cases).

  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.

  1 month post procedure

Secondary Outcomes (23)

• Secondary Endpoint: Individual components of the primary endpoints: all cause mortality over time

  1, 2, 3, 4, 5, 7, 9, and 10 years

• Secondary Endpoint: Individual components of the primary endpoints: Stroke Over Time

  1, 2, 3, 4, 5, 7, 9, and 10 years

• Secondary Endpoint: Individual components of the primary endpoints: Bleeding Events (VARC-3 Type 1, 2, and 3) Over Time

  1, 2, 3, 4, 5, 7, 9, and 10 years

• Secondary Endpoint: Individual components of the primary endpoints: Acute Kidney Injury (AKI) Stage 2-4 Over Time

  1, 2, 3, 4, 5, 7, 9, and 10 years

• Secondary Endpoint: Individual components of the primary endpoints: Rehospitalization for Procedure-Related Event Over Time

  1, 2, 3, 4, 5, 7, 9, and 10 years

Study Arms (2)

TAVR: Myval balloon-expandable THV Series

EXPERIMENTAL

Myval balloon-expandable THV Series will be used for valve replacement

Device: Myval balloon-expandable THV Series

SAVR: Any surgical bioprosthetic valve commercially available at the clinical investigation site

ACTIVE COMPARATOR

Surgical bioprosthetic valve commercially available at the clinical investigation site will be used for valve replacement

Device: Surgical bioprosthetic valve

Interventions

Myval balloon-expandable THV Series DEVICE

Patients receive Myval balloon-expandable THV Series (TAVR)

TAVR: Myval balloon-expandable THV Series

Surgical bioprosthetic valve DEVICE

Patients receive any surgical bioprosthetic valve commercially available at the clinical investigation site (SAVR)

SAVR: Any surgical bioprosthetic valve commercially available at the clinical investigation site

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participant will not be included if any one of the following conditions exists:
• Unable to understand and follow clinical investigation-related instructions or unable to comply with the clinical investigation protocol
• Life expectancy less than 1 year
• Known hypersensitivity or allergy to aspirin, clopidogrel or any Device frame components.
• Under judicial protection, tutorship, or curatorship
• Participation in another trial before the primary endpoint

Sponsors & Collaborators

• Ceric Sàrl: lead
• European Cardiovascular Research Center: collaborator

Study Sites (49)

Medical University of Graz

Graz, 8036, Austria

RECRUITING

University Hostpital Sankt Pölten

Sankt Pölten, 3100, Austria

RECRUITING

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

North-Estonia Medical Centre Foundation

Tallinn, 13419, 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, 60596, Germany

NOT YET RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

NOT YET RECRUITING

German Heart Munich

München, 80636, Germany

NOT YET RECRUITING

Krankenhaus der Barmherzigen Brüder Trier

Trier, 54292, 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, 83013, Italy

NOT YET RECRUITING

IRCCS Ospedale Galeazzi Sant'Ambrogio

Milan, 20157, Italy

NOT YET RECRUITING

Centro Cardiologico Monzino IRCCS

Milan, Italy

NOT YET RECRUITING

Azienda Ospedaliero-Universitaria di Parma

Parma, 43126, Italy

NOT YET RECRUITING

Fondazione Policlinico Campus Bio-Medico di Roma

Roma, 00128, Italy

NOT YET RECRUITING

IRCCS Policlinico San Donato

San Donato Milanese, 20097, Italy

NOT YET RECRUITING

Poznan University Hospital

Poznan, 61848, Poland

NOT YET RECRUITING

Pomorski Uniwersytet Medyczny w Szczecinie

Szczecin, 70111, Poland

NOT YET RECRUITING

Medical Univeristy of Warsaw

Warsaw, 02097, Poland

NOT YET RECRUITING

National Institute of Cardiology

Warsaw, 04628, Poland

NOT YET RECRUITING

Military Institute of Medicine in Warsaw

Warsaw, Poland

NOT YET RECRUITING

Military Hospital in Wroclaw

Wroclaw, 50981, 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, 1000, Slovenia

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

RECRUITING

Hospital clínico universitario de Valladolid

Valladolid, Spain

RECRUITING

CHUV

Lausanne, Switzerland

RECRUITING

Royal Victoria Hospital

Belfast, United Kingdom

NOT YET RECRUITING

University Hospital Sussex NHS foundation Trust

Brighton, United Kingdom

RECRUITING

Royal Papworth Hospital

Cambridge, United Kingdom

NOT YET RECRUITING

Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust

Cottingham, United Kingdom

RECRUITING

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, United Kingdom

RECRUITING

Barts Heart Centre

London, United Kingdom

RECRUITING

Imperial College Healthcare NHS Trust

London, United Kingdom

RECRUITING

Freeman Hospital

Newcastle upon Tyne, United Kingdom

NOT YET RECRUITING

Sheffield Teaching Hopitals NHS Foundation Trust

Sheffield, United Kingdom

NOT YET RECRUITING

Morriston Hospital

Swansea, United Kingdom

RECRUITING

Related Publications (1)

• Milojevic M, Myers PO, Falk V, Bavaria JE, Borger MA, Casselman FPA, Badhwar V, Kaul S, Siepe M, Sadaba JR. Methodological Appraisal of Ongoing Trial of Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Younger Patients: From Incentives to Guideline-Informing Evidence. Eur J Cardiothorac Surg. 2025 Dec 1;67(12):ezaf348. doi: 10.1093/ejcts/ezaf348.

  PMID: 41351226 DERIVED

Study Officials

• Philippe Garot

  European Cardiovascular Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Garot, MD

CONTACT

+330160134602; pgarot@angio-icps.com

Marie-Claude Morrice, MD

CONTACT

mcmorice@cerc-europe.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: March 6, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2037
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

ES (2); PL (7); SE (2); IT (6); CH (1); PT (1); AU (3); DE (4); SL (1); HU (3); RO (3); GB (10); FR (5)