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Surgical vs Transcatheter Aortic Valve Replacement in Young Patients
Sponsor: Ceric Sàrl
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.
Official title: 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
Key Details
Gender
All
Age Range
65 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
1180
Start Date
2025-05-15
Completion Date
2031-11
Last Updated
2025-12-18
Healthy Volunteers
No
Conditions
Interventions
Myval balloon-expandable THV Series
Patients receive Myval balloon-expandable THV Series (TAVR)
Surgical bioprosthetic valve
Patients receive any surgical bioprosthetic valve commercially available at the clinical investigation site (SAVR)
Locations (7)
CHU Lille
Lille, France
Infirmerie Protestante de Lyon
Lyon, France
Massy-Hôpital Jacques Cartier
Massy, France
CHU de Rouen
Rouen, France
Clinique Pasteur
Toulouse, France
Hospital clínico universitario de Valladolid
Valladolid, Spain
CHUV
Lausanne, Switzerland