Evaluation of the Incidence of Cerebral Lesions Post Pulmonary Vein Ablation Catheter (PVAC)

Study Overview
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Brief Summary
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The purpose of the study is to determine the rate of diffusion weighted (DW)-MRI cerebral lesions following a Pulmonary Vein Ablation Catheter (PVAC) ablation procedure performed using best practices, including optimized procedural techniques and anti-coagulation therapy.

Official Title
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Evaluate Reduction in Asymptomatic Cerebral Embolism

Conditions
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Atrial Fibrillation

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is at least 18 years old Subject has been diagnosed with atrial fibrillation (AF) Subject is indicated for a pulmonary vein ablation using PVAC Subject (or subject's legally authorized representative) is able and and willing to give informed consent. Exclusion Criteria: Subject has permanent AF Subject has a left atrial thrombus detected on TEE Subject has had a prior left atrial ablation Subject has a intracardiac thrombus Subject is contraindicated for Warfarin (Coumadin) Subject has a cardiac valve prosthesis Subject has a significant congenital heart defect corrected or not including atrial septal defects or pulmonary vein abnormalities but not including minor PFO) Subject has presence of any pulmonary vein stents Subject has presence of any pre-existing pulmonary vein stenosis Subject has had a cerebral ischemic event (strokes or transient ischemic attacks [TIA]) which occurred during the 6 month interval preceding the Consent Date Subject is a woman known to be pregnant Subject is unwilling or unable to comply fully with study procedures and follow-up

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ablation<br> | Other: Magnetic Resonance Imaging (MRI)<br>* MRI's will be performed on all subjects at Enrollment and Pre-Discharge (Post Ablation). Subjects with a positive MRI (cerebral lesion) at the Pre-Discharge will undergo an MRI at the 1 month follow-up visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New Asymptomatic Cerebral Embolic Lesions, Visualized as 'Bright Spots' on Post-ablation MRI. | An acute embolic lesion is defined as a focal hyper-intense area detected on the diffusion-weighted (DW) sequence, corresponding to a hyper-intense signal intensity in the fluid-attenuated inversion recovery (FLAIR) sequence, and also confirmed by apparent diffusion coefficient (ADC) mapping to rule out a shine-through artifact. | Within 1-3 days post ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Safety Events | Assess the number of procedure or device-related serious adverse events when applying best practices with PVAC. | 30 days | 
| Acute Efficacy, as Determined by Complete Pulmonary Vein Isolation (PVI) Per Subject. | The number of subjects with pulmonary vein isolation (PVI) at the end of ablation procedure. This will characterize if use of best practices during PVAC ablation negatively affects acute efficacy. | Day 1 (End of Procedure) |