A prospective, multi-center study to evaluate the neuro-embolic consequences of Transcatheter Aortic Valve Replacement (TAVR)
Prospective, multi-center study enrolling a minimum of 20 up to a maximum of 80 patients at up to six investigational sites in the United States and European Union. Patients meeting eligibility criteria for TAVR will be enrolled to undergo diffusion-weighted MRI brain imaging pre-procedure (optional) and post-procedure and neuropsychological testing pre- and post-procedure, and at 30 days of follow-up.
Study Type
OBSERVATIONAL
Enrollment
46
Yale New Haven Hospital
New Haven, Connecticut, United States
Baptist Hospital of Miami
Miami, Florida, United States
Columbia University Medical Center
Fort Lee, New Jersey, United States
St. Francis Hospital
Roslyn, New York, United States
Incidence of diffusion-weighted MRI lesions following TAVR without cerebral embolic protection
Number of new diffusion-weighted MRI lesions
Time frame: 1 week post procedure
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The Heart Hospital Baylor Plano
Plano, Texas, United States