NCT05217888

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 158 (actual)
• Sponsor: Duk-Woo Park, MD · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Aortic Valve Disease
• Transcatheter Aortic Valve Implantation
• Transcatheter Aortic Valve Replacement

Interventions

Type	Name	Description
DEVICE	Sentinel	cerebral protection devices during transfemoral transcatheter aortic valve replacement

Timeline

• Start date: 2022-05-18
• Primary completion: 2025-05-20
• Completion: 2025-05-20
• First posted: 2022-02-01
• Last updated: 2025-06-13

Locations

10 sites across 1 country: South Korea