Comparison of Hemodynamic Performance of Transcatheter Aortic Valve Replacement With Supra-Annular Self-Expanding Versus Balloon-Expandable Valves Assessed by Exercise Cardiovascular Magnetic Resonance
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 105
Healthy Volunteers: f
View:
• Aortic valve stenosis with clinical indication for valve replacement decided by a dedicated heart team;
• Planned transfemoral TAVR; 18 years of age or older;
• Able to give informed consent.
Locations
United States
Ohio
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Contact Information
Primary
Luis Dallan, MD
luisdallan@yahoo.com
216-844-1000
Backup
LaStasha Cowan
lastasha.cowan@uhhospitals.org
216-844-1000
Time Frame
Start Date: 2023-11-21
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 90
Treatments
Active_comparator: TAVR using the self-expanding valve Evolut FX
Transcatheter aortic valve replacement (TAVR) using the bioprosthesis Medtronic Evolut FX supra-annular self-expanding valve
Active_comparator: TAVR using the balloon-expandable valve Sapien 3 Ultra
Transcatheter aortic valve replacement (TAVR) using the bioprosthesis Edwards Sapien 3 Ultra valve
Related Therapeutic Areas
Sponsors
Leads: University Hospitals Cleveland Medical Center