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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Randomized Study of the Use of The Sentinel Device for Cerebral Protection During Atrial Fibrillation Ablation: MRI Imaging and Laboratory Sub-study

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Magnetic Resonance Imaging (MRI)
* Other: Laboratory Testing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parent Study Design: Patients undergoing clinically indicated catheter ablation for AF in the parent study will be randomized 2:1 to two arms: (1) cerebral protection with the Sentinel device and (2) control group without cerebral protection
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cerebral protection with the Sentinel device<br>Subjects who received the Sentinel device in the parent study | Device: Magnetic Resonance Imaging (MRI)<br>* Cerebral MRI will be performed without gadolinium contrast using a 3 Tesla scanner prior to and 1 to 7 days after catheter ablation<br>Other: Laboratory Testing<br>* Laboratory blood testing to include high sensitivity CRP (hs-CRP), interleukin-6 (IL-6), NT-proBNP and high sensitivity troponin prior to and post-ablation<br>|
| Active Comparator: Control group without cerebral protection<br>Subjects who did not received the Sentinel device in the parent study | Device: Magnetic Resonance Imaging (MRI)<br>* Cerebral MRI will be performed without gadolinium contrast using a 3 Tesla scanner prior to and 1 to 7 days after catheter ablation<br>Other: Laboratory Testing<br>* Laboratory blood testing to include high sensitivity CRP (hs-CRP), interleukin-6 (IL-6), NT-proBNP and high sensitivity troponin prior to and post-ablation<br>|

What is the study measuring?
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Primary Outcome Measures

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