Prospective Evaluation of CT Guided Ablation of Cardiac Ganglionated Plexi

Study Overview
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Brief Summary
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Despite progress made in treating atrial fibrillation with catheter ablation, outcomes remain suboptimal with pulmonary vein isolation alone. Ablation of ganglionated plexi (GP) has been shown to be beneficial in patients with atrial fibrillation although optimal strategies of localization of these regions have yet to be determined. The investigators aim to develop a novel strategy of CT guided GP localization to guide ablation in patients with atrial fibrillation. The investigators also aim to clarify the network of innervation between GP to clarify the optimal ablation strategy. This is an observational, single-center study evaluating feasibility and efficacy of CT and high frequency stimulation (HFS) guided GP mapping and ablation in patients with AF undergoing catheter ablation with pulmonary vein isolation. Patients will undergo HFS and CT guided mapping of GPs followed by allocation into one of 8 different GP ablation approaches in a non-randomized fashion.

Official Title
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Prospective Evaluation of Computed Tomography Guided Ablation of Cardiac Ganglionated Plexi in Patients With Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Ganglionated Plexi mapping and ablation using Natus Cortical Stimulator and standard ablation catheters


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, aged 18 years History of AF with plan to undergo catheter ablation Exclusion Criteria: Contraindication or unwillingness to undergo CT imaging or catheter ablation. Pregnancy or lactation

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Atrial fibrillation ablation<br>All patients undergoing ablation with undergo pre-procedural CT as well as HFS mapping and ablation of GPs. | Device: Ganglionated Plexi mapping and ablation using Natus Cortical Stimulator and standard ablation catheters<br>* Ganglionated plexi will be mapped using high frequency stimulation with standard ablation catheters attached to a Natus Cortical Stimulator for high frequency stimulation. Vagal innervation to the heart will be assessed with non-invasive Parasym tragal stimulation.<br>* Other names: Vagal stimulation using Parasym tragal stimulator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between HFS (high frequency signals) and CT identified epicardial adipose tissue. | Correlation will be defined by sites being found within 3 pixels (0.625x3=1.875mm). | During Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HFS (high frequency stimulation) response elimination | Elimination of local of HFS response following GP ablation | during procedure | 
| Global vagal response elimination | Elimination of global vagal response to non-invasive tragal stimulation | This will be assessed during the procedure. | 
| Ablation site changes - amplitude of signals | Characterization of amplitude signals at sites with HFS responses and successful HFS elimination | This will be assessed during the procedure. | 
| Ablation site changes - duration of signals | Characterization of duration of signals at sites with HFS responses and successful HFS elimination | This will be assessed during the procedure. | 
| Ablation site changes - fractionation of signals | Characterization of fractionation of signals at sites with HFS responses and successful HFS elimination | This will be assessed during the procedure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Ganglionated Plexus, Cardioneural Ablation