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A Study to Assess the Use of The Sentinel Device During 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: MRI Imaging and Laboratory Sub-study

Clinical Trial Summary

Researchers are determining whether the use of the Sentinel cerebral protection device during atrial fibrillation ablation will affect the occurrence of new cerebral infarcts in brain MRI. We are also studying if laboratory tests can be used to predict the rate of cerebral infarction and microbleeds in patients undergoing atrial fibrillation (AF) ablation procedures with and without use of the Sentinel Device.

Clinical Trial Description

Patients currently participating in the research study titled: "A Pilot Randomized Study of the Use of the Sentinel Device for Cerebral Protection during Atrial Fibrillation Ablation" will be asked to participate in this sub-study to collect additional MRI and laboratory data to support the main study. This study will assess the number, size and volume of new cerebral emboli in protected territories detected using MRI of the brain within 7 days after AF ablation in patients treated with the Sentinel device compared to controls not receiving the Sentinel device, and to assess if change in blood inflammatory markers is associated with silent cerebral lesions. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04683692
Study type Interventional
Source Mayo Clinic
Contact
Status Withdrawn
Phase N/A
Start date March 2023
Completion date December 2024
View Details
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