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Clinical Trials/NCT04642976
NCT04642976
Completed
Not Applicable

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

University of Pennsylvania1 site in 1 country30 target enrollmentJanuary 20, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
University of Pennsylvania
Enrollment
30
Locations
1
Primary Endpoint
Correlation Between HFS (High Frequency Stimulation) Response and CT Identified Epicardial Adipose Tissue.
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 20, 2021
End Date
January 1, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Correlation Between HFS (High Frequency Stimulation) Response and CT Identified Epicardial Adipose Tissue.

Time Frame: 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 Outcomes

  • HFS (High Frequency Stimulation) Response Elimination(during procedure)
  • Global Vagal Response Elimination(This will be assessed during the procedure.)
  • Ablation Site Changes - Amplitude of Signals(This will be assessed during the procedure.)
  • Ablation Site Changes - Duration of Signals(This will be assessed during the procedure.)
  • Ablation Site Changes - Fractionation of Signals(This will be assessed during the procedure.)

Study Sites (1)

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