Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients

Official title

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

Overview

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.

Detailed description

Prospective, randomized, multinational, multicenter, open label, trial of 1180 patients treated with surgical bioprosthetic aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR).

Interventions

• Device Myval balloon-expandable THV Series
  Patients receive Myval balloon-expandable THV Series (TAVR)
• Device Surgical bioprosthetic valve
  Patients receive any surgical bioprosthetic valve commercially available at the clinical investigation site (SAVR)

Primary outcome measures

• 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. [Time frame: 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 [Time frame: 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). [Time frame: 1 month post procedure]

Secondary outcome measures (12)

• Secondary Endpoint: Individual components of the primary endpoints: all cause mortality over time [Time frame: 1, 2, 3, 4, 5, 7, 9, and 10 years]
• Secondary Endpoint: Individual components of the primary endpoints: Stroke Over Time [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 1, 2, 3, 4, 5, 7, 9, and 10 years]
• Secondary Endpoint: Individual components of the primary endpoints: Reintervention for Aortic Valve Dysfunction Over Time [Time frame: 1, 2, 3, 4, 5, 7, 9, and 10 years]
• Secondary Endpoint: Feasibility of re-TAVR based on CT scan evaluation (CT scan, for selected sites only) [Time frame: 1 month post procedure]
• Secondary Endpoint: Number of Participants Requiring New Permanent Pacemaker Implantation (PPI) Due to Conduction System Disturbances [Time frame: 1 month post procedure]
• Secondary Endpoint: Rate of prosthetic valve regurgitation (moderate or severe) [Time frame: 1 year post procedure]
• Secondary Endpoint: Number of Participants with Major Vascular Complications (VARC-3 Criteria) [Time frame: 1 month post procedure]
• Secondary Endpoint: Performance of the aortic valve : Gradients (mean/max) assessed by TTE [Time frame: 1 year and 3 years post procedure]
• Secondary Endpoint: Performance of the aortic valve : paravalvular leakage (PVL) grade evaluated by transthoracic echocardiogram (TTE) [Time frame: 1 year and 3 years post procedure]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United Kingdom · 10 centers

• Royal Victoria Hospital — Belfast
• University Hospital Sussex NHS foundation Trust — Brighton
• Royal Papworth Hospital — Cambridge
• Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust — Cottingham
• University Hospitals Coventry and Warwickshire NHS Trust — Coventry
• Barts Heart Centre — London
• Imperial College Healthcare NHS Trust — London
• Freeman Hospital — Newcastle upon Tyne
• … and 2 more centers

Poland · 7 centers

• Poznan University Hospital — Poznan
• Pomorski Uniwersytet Medyczny w Szczecinie — Szczecin
• Medical Univeristy of Warsaw — Warsaw
• National Institute of Cardiology — Warsaw
• Military Institute of Medicine in Warsaw — Warsaw
• Military Hospital in Wroclaw — Wroclaw
• Provincial Specialist Hospital in Wroclaw — Wroclaw

Italy · 6 centers

• Montevergine Clinic — Mercogliano
• IRCCS Ospedale Galeazzi Sant'Ambrogio — Milan
• Centro Cardiologico Monzino IRCCS — Milan
• Azienda Ospedaliero-Universitaria di Parma — Parma
• Fondazione Policlinico Campus Bio-Medico di Roma — Roma
• IRCCS Policlinico San Donato — San Donato Milanese

France · 5 centers

• CHU Lille — Lille
• Infirmerie Protestante de Lyon — Lyon
• Massy-Hôpital Jacques Cartier — Massy
• CHU de Rouen — Rouen
• Clinique Pasteur — Toulouse

Germany · 4 centers

• University Hospital Frankfurt — Frankfurt
• Universitätsklinikum Hamburg-Eppendorf — Hamburg
• German Heart Munich — München
• Krankenhaus der Barmherzigen Brüder Trier — Trier

Austria · 3 centers

• Medical University of Graz — Graz
• University Hostpital Sankt Pölten — Sankt Pölten
• Medical University of Vienna — Vienna

Hungary · 3 centers

• Gottsegen National Cardiovascular Center — Budapest
• Department of Cardiology and Cardiac Surgery, University of Debrecen — Debrecen
• University of Szeged — Szeged

Romania · 3 centers

• Bucharest Clinical Emergency Hospital — Bucharest
• Central military emergency university hospital — Bucharest
• IBCV Iasi — Iași

Serbia · 2 centers

• University Clinical Center of Serbia — Belgrade
• Institute of Cardiovascular Diseases of Vojvodina — Kamenitz

Spain · 2 centers

• Hospital Universitario Central de Asturias — Oviedo
• Hospital clínico universitario de Valladolid — Valladolid

Estonia · 1 center

• North-Estonia Medical Centre Foundation — Tallinn

Portugal · 1 center

• Hospital de Santa Cruz, ULSLO — Carnaxide

Slovenia · 1 center

• UKC Ljubljana — Ljubljana

Switzerland · 1 center

• CHUV — Lausanne

Publications

• 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

Identifiers

NCT: NCT06861361 · START YOUNG

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗