Surgical vs Transcatheter Aortic Valve Replacement in Young Patients
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
Ceric Sàrl
1,180 participants
May 15, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria6
- 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
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Interventions
Patients receive Myval balloon-expandable THV Series (TAVR)
Patients receive any surgical bioprosthetic valve commercially available at the clinical investigation site (SAVR)
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT06861361