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
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 75
Healthy Volunteers: f
View:
⁃ 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
Locations
Other Locations
France
CHU Lille
RECRUITING
Lille
Infirmerie Protestante de Lyon
RECRUITING
Lyon
Massy-Hôpital Jacques Cartier
RECRUITING
Massy
CHU de Rouen
NOT_YET_RECRUITING
Rouen
Clinique Pasteur
RECRUITING
Toulouse
Spain
Hospital clínico universitario de Valladolid
RECRUITING
Valladolid
Switzerland
CHUV
ACTIVE_NOT_RECRUITING
Lausanne
Time Frame
Start Date: 2025-05-15
Estimated Completion Date: 2031-11
Participants
Target number of participants: 1180
Treatments
Experimental: TAVR: Myval balloon-expandable THV Series
Myval balloon-expandable THV Series will be used for valve replacement
Active_comparator: SAVR: Any surgical bioprosthetic valve commercially available at the clinical investigation site
Surgical bioprosthetic valve commercially available at the clinical investigation site will be used for valve replacement
Related Therapeutic Areas
Sponsors
Leads: Ceric Sàrl