A Study to Assess the Use of The Sentinel Device During Atrial Fibrillation Ablation

Not Applicable

Withdrawn

Interventions: Device: Magnetic Resonance Imaging (MRI)
Other: Laboratory Testing

Brief 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.

Detailed 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.

Recruitment & Eligibility

Inclusion Criteria

Patients over the age of 18 years undergoing radiofrequency or cryoballoon ablation for AF who provide informed consent will be included

Exclusion Criteria

Severe peripheral arterial disease that precludes deployment of Sentinel device
Unable to undergo MRI brain due to the presence of an MRI noncompatible implanted device
Unable or unwilling to provide informed consent.
Known history of dementia.

Arm && Interventions

Group	Intervention	Description
Cerebral protection with the Sentinel device	Laboratory Testing	Subjects who received the Sentinel device in the parent study
Control group without cerebral protection	Laboratory Testing	Subjects who did not received the Sentinel device in the parent study
Cerebral protection with the Sentinel device	Magnetic Resonance Imaging (MRI)	Subjects who received the Sentinel device in the parent study
Control group without cerebral protection	Magnetic Resonance Imaging (MRI)	Subjects who did not received the Sentinel device in the parent study

Primary Outcome Measures

Name	Time	Method
Change in high sensitivity CRP (hs-CRP)	baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation	High sensitivity CRP (hs-CRP) measured in mg/L to detect changes in peripheral markers of inflammation
Change in NT-proBNP	baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation	NT-proBNP measured in pg/ml to detect changes in tissue damage
New cerebral infarcts	day 1 to 7 after atrial fibrillation ablation	Total number of new cerebral infarcts in the protected territories detected on brain MRI after ablation in the Sentinel device group vs control group
Change in interleukin-6 (IL-6)	baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation	Interleukin-6 measured in pg/ml to detect changes in peripheral markers of inflammation
Change in high sensitivity troponin	baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation	High sensitivity troponin measure in ng/mL to detect changes in tissue damage

Secondary Outcome Measures

Name	Time	Method

Locations (1): Mayo Clinic in Rochester
🇺🇸
Rochester, Minnesota, United States

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