The SENTINEL Post-Market Registry is a prospective, multi-center, registry using the CE-Marked Sentinel System in subjects with severe symptomatic calcified native aortic valve stenosis indicated for TAVR. Subjects enrolled in the registry will undergo TAVR + Sentinel. Basic demographic information and detailed procedural data will be captured and documented in a registry case report form. All Sentinel filters will be sent for histopathology at an independent core-lab.
Study Type
OBSERVATIONAL
Enrollment
300
Primary Observational Endpoint
Capture rate, debris volume and histopathology analysis at day 1.
Time frame: Post-Procedure (day 1)
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