Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients

Recruiting now · Not applicable

Conditions studied: Symptomatic Severe Aortic Stenosis

In brief

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.

Key facts

Study ID

NCT06861361

Run by

Ceric Sàrl

People needed

1180

Starts

2025-05-15

Expected to finish

2037-09-01

Last updated by the study team

2026-05-12

Who can join

Age: 65 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Medical University of Graz — Graz, Austria (enrolling)
• University Hostpital Sankt Pölten — Sankt Pölten, Austria (enrolling)
• Medical University of Vienna — Vienna, Austria (enrolling)
• North-Estonia Medical Centre Foundation — Tallinn, Estonia (enrolling)
• CHU Lille — Lille, France (enrolling)
• Infirmerie Protestante de Lyon — Lyon, France (enrolling)
• Massy-Hôpital Jacques Cartier — Massy, France (enrolling)
• Clinique Pasteur — Toulouse, France (enrolling)
• Hospital de Santa Cruz, ULSLO — Carnaxide, Portugal (enrolling)
• Institute of Cardiovascular Diseases of Vojvodina — Kamenitz, Serbia (enrolling)
• UKC Ljubljana — Ljubljana, Slovenia (enrolling)
• Hospital Universitario Central de Asturias — Oviedo, Principality of Asturias, Spain (enrolling)
• Hospital clínico universitario de Valladolid — Valladolid, Spain (enrolling)
• CHUV — Lausanne, Switzerland (enrolling)
• University Hospital Sussex NHS foundation Trust — Brighton, United Kingdom (enrolling)
• Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust — Cottingham, United Kingdom (enrolling)
• University Hospitals Coventry and Warwickshire NHS Trust — Coventry, United Kingdom (enrolling)
• Barts Heart Centre — London, United Kingdom (enrolling)
• Imperial College Healthcare NHS Trust — London, United Kingdom (enrolling)
• Morriston Hospital — Swansea, United Kingdom (enrolling)
• 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

Full record on ClinicalTrials.gov

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