Replacement of the aortic valve by surgery or by a catheter-implanted prosthesis (THV Myval) in patients aged 65 to 75 years with severe aortic valve stenosis.
Zusammenfassung der Studie
Aortic stenosis (AS) is the most common heart valve disease in people over 65 years old. It becomes more common with age. Currently, recommendations suggest surgical operation (SAVR) to replace the aortic valve in patients under 75 years old. In older or high-risk patients, a less invasive method called TAVR (transcatheter aortic valve replacement) is preferred. SAVR is the standard method, but TAVR is a promising alternative. Some studies have shown that TAVR yields similar results to SAVR, but its long-term effectiveness in patients aged 65 to 75 years remains to be proven. The START YOUNG study is a prospective clinical study conducted in several hospitals. It is randomized: patients are allocated by random draw (1:1) into two groups. One will receive a TAVR with the THV Myval valve, the other will undergo surgery (SAVR). The study will include 1,180 patients aged 65 to 75 years. All devices are CE certified and comply with clinical standards. In each hospital, two departments participate: interventional cardiology for TAVR and surgery for SAVR, each with a responsible physician. The objective is to demonstrate that TAVR with the THV Myval valve provides clinical results comparable to surgery in patients aged 65 to 75 years with severe aortic stenosis. Included and consenting patients will be followed for 5 years, with visits at 30 days, 12 months, and then annually. Patient inclusion is expected to last about 18 months.
(BASEC)
Untersuchte Intervention
The aim of the study is to demonstrate that the clinical outcomes of the THV Myval valve, implanted via catheter and expandable balloon, are not inferior to those of conventional surgery (SAVR) in patients aged 65 to 75 years with symptomatic severe aortic stenosis.
Participants will be randomly assigned (1:1) into two groups:
• The first will receive a THV Myval heart valve implanted via catheter (procedure performed by an interventional cardiologist).
• The second will receive a valve through conventional cardiac surgery (performed by a cardiac surgeon).
All procedures will follow the standard practices of each hospital. Only CE certified devices will be used for this study.
(BASEC)
Untersuchte Krankheit(en)
acquired aortic valve stenosis (AS)
(BASEC)
1. Age ≥ 65 and ≤ 75 2. Symptomatic severe aortic stenosis. 3. Feasibility and approval for surgical aortic valve replacement (SAVR) and transfemoral TAVR by the local multidisciplinary cardiac team. 4. Signed informed consent for participation in the study. (BASEC)
Ausschlusskriterien
1. Patients with hypersensitivity or allergy to aspirin, heparin, clopidogrel, ticlopidine, cobalt, chrome, nickel, or any contrast agent. 2. Clinical situations prohibiting cardiac interventional procedures, such as ongoing infective endocarditis or any similar infection. 3. Participation in another trial prior to the assessment of the primary endpoint. (BASEC)
Studienstandort
Lausanne
(BASEC)
Sponsor
Center for European Research Initiatives in Cardiovascular Medicine (CERIC)
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Ravi Kumar Khetavat
+33 06 60 05 54 68
rkhetavat@cluttercerc-europe.orgCardiovascular European Research Center (CERC)
(BASEC)
Allgemeine Auskünfte
European Cardiovascular Research Center
+330160134602
pgarot@angio-icps.com(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Waadt
(BASEC)
Datum der Bewilligung durch die Ethikkommission
08.09.2025
(BASEC)
ICTRP Studien-ID
NCT06861361 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Remplacement de la valve aortique par bioprothèse chirurgicale vs. série THV Myval à expansion par ballon chez des patients âgés de 65 à 75 ans présentant une sténose aortique sévère symptomatique. (BASEC)
Wissenschaftlicher Titel
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 (ICTRP)
Öffentlicher Titel
Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients (ICTRP)
Untersuchte Krankheit(en)
Symptomatic Severe Aortic Stenosis (ICTRP)
Untersuchte Intervention
Device: Myval balloon-expandable THV SeriesDevice: Surgical bioprosthetic valve (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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 (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
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.;Primary efficacy endpoint at 1 year (non-inferiority): Composite measure of all-cause death, any stroke, or rehospitalization for valve related event;CT Scan Sub Study endpoints: primary endpoint : prevalence of feasible redoTAVR or ViV TAVR without requiring leaflet modifications techniques (green cases). (ICTRP)
Secondary Endpoint: Individual components of the primary endpoints: all cause mortality over time;Secondary Endpoint: Individual components of the primary endpoints: Stroke Over Time;Secondary Endpoint: Individual components of the primary endpoints: Bleeding Events (VARC-3 Type 1, 2, and 3) Over Time;Secondary Endpoint: Individual components of the primary endpoints: Acute Kidney Injury (AKI) Stage 2-4 Over Time;Secondary Endpoint: Individual components of the primary endpoints: Rehospitalization for Procedure-Related Event Over Time;Secondary Endpoint: Individual components of the primary endpoints: Reintervention for Aortic Valve Dysfunction Over Time;Secondary Endpoint: Feasibility of re-TAVR based on CT scan evaluation (CT scan, for selected sites only);Secondary Endpoint: Number of Participants Requiring New Permanent Pacemaker Implantation (PPI) Due to Conduction System Disturbances;Secondary Endpoint: Rate of prosthetic valve regurgitation (moderate or severe);Secondary Endpoint: Number of Participants with Major Vascular Complications (VARC-3 Criteria);Secondary Endpoint: Performance of the aortic valve : Gradients (mean/max) assessed by TTE;Secondary Endpoint: Performance of the aortic valve : paravalvular leakage (PVL) grade evaluated by transthoracic echocardiogram (TTE);Secondary Endpoint: Performance of the aortic valve : effective orifice are (EOA) evaluated by transthoracic echocardiogram (TTE);Secondary Endpoint: Number of Participants with Structural Valve Deterioration (VARC-3) and/or Requiring Redo-TAVR or Valve Explantation;CT Scan Sub Study endpoints: Secondary outcomes : feasibility of redoTAVR or ViV TAVR with or without requiring leaflet modification techniques;CT Scan Sub Study endpoints: Secondary outcomes: prevalence of HALT in both TAVR and SAVR groups;CT Scan Sub Study endpoints: Secondary outcomes: Impact of HALT on Mean Transvalvular Gradient - Valve Hemodynamics;CT Scan Sub Study endpoints: Secondary outcomes: Impact of HALT on Peak Transvalvular Gradient - Valve Hemodynamics;CT Scan Sub Study endpoints: Secondary outcomes: Impact of HALT on Effective Orifice Area (EOA) - Valve Hemodynamics;CT Scan Sub Study endpoints: Secondary outcomes: Mean Transvalvular Gradient - THV Hemodynamics;CT Scan Sub Study endpoints: Secondary outcomes: Peak Transvalvular Gradient - THV Hemodynamics;CT Scan Sub Study endpoints: Secondary outcomes: Effective Orifice Area (EOA) - THV Hemodynamics;CT Scan Sub Study endpoints: Secondary outcomes: Commissural Alignment of THV (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
European Cardiovascular Research Center (ICTRP)
Weitere Kontakte
Philippe GarotPhilippe Garot, MD, pgarot@angio-icps.com, +330160134602, European Cardiovascular Research Center (ICTRP)
Sekundäre IDs
START YOUNG (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT06861361 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar