Prospective Evaluation of CT Guided Ablation of Cardiac Ganglionated Plexi

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-20

Study Completion Date

2024-01-01

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.

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Atrial fibrillation ablation

All patients undergoing ablation with undergo pre-procedural CT as well as HFS mapping and ablation of GPs.

Ganglionated Plexi mapping and ablation using Natus Cortical Stimulator and standard ablation catheters

Intervention Type DEVICE

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.

Interventions

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Ganglionated Plexi mapping and ablation using Natus Cortical Stimulator and standard ablation catheters

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.

Intervention Type DEVICE

Other Intervention Names

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Vagal stimulation using Parasym tragal stimulator

Eligibility Criteria

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Inclusion Criteria

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18 years
4. History of AF with plan to undergo catheter ablation