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Safety and Efficacy of the Sentinel Cerebral Protection Device in Atrial Fibrillation Ablation
Sponsor: Malini Madhavan
Summary
The purpose of the study is to see if the Sentinel® Cerebral Protection System may prevent occurrence of stroke during an ablation procedure for atrial fibrillation (AF). The secondary purpose of this study is to study if cognitive function after AF ablation differs between those treated with the Sentinel cerebral protection device and those who do not receive the device.
Official title: A Pilot Randomized Study of the Use of The Sentinel Device for Cerebral Protection During Atrial Fibrillation Ablation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2023-03-07
Completion Date
2026-12
Last Updated
2025-06-11
Healthy Volunteers
No
Conditions
Interventions
Sentinel® Cerebral Protection System
A percutaneously delivered dual-filter protection device, designed to capture and remove debris dislodged during transcatheter aortic valve replacement procedures.
Magnetic Resonance Imaging
Cerebral MRI will be performed without gadolinium contrast using a 3 Tesla scanner prior to and 1 to 7 days after catheter ablation
Locations (1)
Mayo Clinic in Rochester
Rochester, Minnesota, United States