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MRI in Transcatheter Aortic Valve Replacement Patients
Sponsor: University Hospitals Cleveland Medical Center
Summary
The hypothesis is that SEV result in superior valvular hemodynamics (more pronounced during exercise) and exercise capacity relative to BEV. Furthermore, the hypothesis is that stress CMR will be able to demonstrate differences in these hemodynamic parameters. CMR will also provide refined assessment of paravalvular leak and its impact on ventricular function and on clinical outcomes.
Official title: Comparison of Hemodynamic Performance of Transcatheter Aortic Valve Replacement With Supra-Annular Self-Expanding Versus Balloon-Expandable Valves Assessed by Exercise Cardiovascular Magnetic Resonance
Key Details
Gender
All
Age Range
18 Years - 105 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2023-11-21
Completion Date
2026-12-30
Last Updated
2025-12-17
Healthy Volunteers
No
Conditions
Interventions
Self-expanding valve (Medtronic Evolut FX)
Bioprothesis Medtronic Evolut FX supra-annular self-expanding valve
Balloon-expanding valve (Edwards Sapien 3 Ultra RESILIA)
Bioprosthesis Edwards Sapien 3 Ultra valve
Locations (1)
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States