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Safety and Efficacy of the Sentinel Cerebral Protection Device in Atrial Fibrillation Ablation

Atrial Fibrillation Clinical Trial

Official title:
A Pilot Randomized Study of the Use of The Sentinel Device for Cerebral Protection During Atrial Fibrillation Ablation

Clinical Trial 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.

Clinical Trial Description

If assigned to receive the device, the Sentinel® Cerebral Protection System will be placed in your heart at the beginning of your ablation procedure, and then removed along with any collected blood debris upon completion of your procedure. The study team will then call you 30 days after your procedure to assess any neurological events. Your final visit will be 90 days after your procedure to complete a second 30 minute session of cognitive testing. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04685317
Study type Interventional
Source Mayo Clinic
Contact Grace Purkey
Phone (507) 255-0774
Email Purkey.Grace@mayo.edu
Status Recruiting
Phase N/A
Start date March 7, 2023
Completion date June 2025
View Details
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