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Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients

RecruitingNAAges 65 Years - 75 YearsAllCeric Sàrl
NCT06861361 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Myval balloon-expandable THV Series
  • Surgical bioprosthetic valve
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Where

49 sites
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

…and 41 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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