The Sentinel Registry

Evaluation of Procedural Outcomes and Safety of Cerebral Embolic Protection Device for Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement in Routine Clinical Practice, A Multicenter, Prospective Observational Study

This registry is to evaluate procedural outcomes and safety outcomes of cerebral protection devices during transfemoral TAVR in real-world clinical practice.

The data from this registry will be compared with the extracted data from the TP TAVR registry(NCT038262664) using Propensity Score Matching.

Inclusion Criteria:

• Age 19 and more

• Undergoing TAVR with the use of SENTINEL embolic protection device

• Higher risk of cerebrovascular embolic events (any of the followings)

  1. Bicuspid aortic valve
  2. Calcified lesion or atherosclerosis in the ascending aorta and/or aortic arch
  3. Heavy calcified aortic valve (Ca. volume > 500)
  4. Chronic kidney disease
  5. Prior stroke
  6. Stroke risk is strongly anticipated by attending physicians

• Compatible carotid and brachiocephalic artery anatomy for SENTINEL device as determined by Multi-Slice Computed Tomography scan or equivalent imaging modality

• Agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

• Vasculature in the right extremity precluding radial or brachial access
• Excessive tortuosity in the right radial/brachial/subclavian artery preventing Sentinel System access and insertion
• Inadequate circulation to the right extremity as evidenced by signs of artery occlusion (modified Allen's test) or absence of radial/brachial pulse
• Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature
• Symptomatic or asymptomatic severe occlusive carotid disease requiring concomitant carotid endarterectomy/stenting
• Undergone carotid stenting or carotid endarterectomy within the previous 6 weeks
• Concurrent medical condition with a life expectancy of less than 1 year