Prospective Evaluation of CT Guided Ablation of Cardiac Ganglionated Plexi

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: Ganglionated Plexi mapping and ablation using Natus Cortical Stimulator and standard ablation catheters

• Registration Number: NCT04642976
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-11-13
• Study First Submitted QC: 2020-11-23
• Study First Posted: 2020-11-24
• Study Start: 2021-01-20
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01
• Results First Submitted: 2024-04-15
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-09
• Last Update Submitted: 2024-10-09
• Results First Posted: 2024-10-11
• Last Update Posted: 2024-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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Exclusion Criteria

1. Contraindication or unwillingness to undergo CT imaging or catheter ablation.
2. Pregnancy or lactation

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Atrial fibrillation ablation	Ganglionated Plexi mapping and ablation using Natus Cortical Stimulator and standard ablation catheters	All patients undergoing ablation with undergo pre-procedural CT as well as HFS mapping and ablation of GPs.

Primary Outcome Measures

Name	Time	Method
Correlation Between HFS (High Frequency Stimulation) Response and CT Identified Epicardial Adipose Tissue.	During Procedure	Number of patients with HFS response identified within 3 pixels (0.625x3=1.875mm) of a location where CT identified epicardial adipose tissue.

Secondary Outcome Measures

Name	Time	Method
HFS (High Frequency Stimulation) Response Elimination	during procedure	Elimination of local of HFS response following GP ablation
Global Vagal Response Elimination	This will be assessed during the procedure.	Elimination of global vagal response to non-invasive tragal stimulation
Ablation Site Changes - Amplitude of Signals	This will be assessed during the procedure.	Characterization of amplitude signals at sites with HFS responses and successful HFS elimination
Ablation Site Changes - Duration of Signals	This will be assessed during the procedure.	Characterization of duration of signals at sites with HFS responses and successful HFS elimination
Ablation Site Changes - Fractionation of Signals	This will be assessed during the procedure.	Characterization of fractionation of signals at sites with HFS responses and successful HFS elimination

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States