Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients
ConditionSymptomatic Severe Aortic Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-75
SponsorCeric Sàrl
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Myval balloon-expandable THV Series
- Surgical bioprosthetic valve
Treatment groups
1,180 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ceric Sàrl
Lead sponsor
European Cardiovascular Research Center
Collaborator
Source ClinicalTrials.gov