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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Arrhythmia, Atrial Fibrillation

Intervention / Treatment
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* Device: Sentinel® Cerebral Protection System
* Diagnostic Test: Magnetic Resonance Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men / women over the age of 18 years undergoing radiofrequency or cryo-balloon ablation for AF in accordance with the current AHA/ACC/HRS guideline for management of patients with atrial fibrillation. This includes patients with symptomatic paroxysmal, persistent or long-standing persistent AF not responsive to or intolerant of a Class I or III anti-arrhythmic drug or patients with symptomatic paroxysmal or persistent AF prior to the initiation of a Class I or Class III antiarrhythmic drug). The decision to perform catheter ablation for AF will be made by the treating provider and the patient in accordance with the guidelines noted above. (January et al. J Am Coll Cardiol vol. 64, No. 21, 2014, page e1) Able to provide informed consent. Patients should have acceptable aortic arch anatomy and vessel diameters without significant stenosis as assessed using pre-procedure CT angiogram. Exclusion Criteria: Anatomy unsuitable for use of Sentinel device: Right extremity vasculature not suitable due to compromised arterial blood flow. Brachiocephalic, left carotid or aortic arch not suitable due to excessive tortuosity, significant ectasia, stenosis (>70%), dissection or aneurysm. Cerebrovascular accident or transient ischemic attack within six months Carotid disease requiring treatment within six weeks Unable or unwilling to provide informed consent. Pregnant women Known history of dementia. Known hypersensitivity to nickel-titanium. Presence of MRI non-compatible implanted devices including cardiac implantable electronic devices. The presence of left atrial thrombus. All patients routinely undergo transesophageal echocardiogram prior to ablation and / or intra-cardiac echocardiogram at the beginning of the ablation procedure to rule out the presence of left atrial thrombus. Patients with a reversible cause for AF such as hyperthyroidism.

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: Randomized study of Sentinel cerebral protection device vs no cerebral protection device in patients undergoing atrial fibrillation ablation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sentinel® Cerebral Protection System Group<br>Sentinel® Cerebral Protection System in patients undergoing AF catheter ablation | Device: Sentinel® Cerebral Protection System<br>* A percutaneously delivered dual-filter protection device, designed to capture and remove debris dislodged during transcatheter aortic valve replacement procedures.<br>Diagnostic Test: Magnetic Resonance Imaging<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 names: MRI;|
| Active Comparator: Standard of Care Group<br>Standard of care (no cerebral protection device) in patients undergoing AF catheter ablation | Diagnostic Test: Magnetic Resonance Imaging<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 names: MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incident of stroke / TIA 7 days post AF ablation | Incidence of stroke / TIA confirmed using physical examination and / or brain imaging during or within 7 days of the AF ablation | 7 days post AF ablation | 
| Incident of stroke / TIA 90 days post AF ablation | Incidence of stroke / TIA during or within 90 days of the AF ablation | 90 days post AF ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in neurocognitive function score | Montreal cognitive assessment will administered at baseline and 90 days following ablation. Change in cognitive function score will be compared between the groups. The score ranges from 0 to 30 with higher score indicating better cognitive performance. | Baseline, 90 days | 
| 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 |