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OpenTrials
Completed

NCT Number: NCT04642976

Prospective Evaluation of CT Guided Ablation of Cardiac Ganglionated Plexi

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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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Other names: Vagal stimulation using Parasym tragal stimulator

Primary outcomes

  1. 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

  1. HFS (High Frequency Stimulation) Response Elimination

    Time frame: during procedure

    Elimination of local of HFS response following GP ablation

  2. Global Vagal Response Elimination

    Time frame: This will be assessed during the procedure.

    Elimination of global vagal response to non-invasive tragal stimulation

  3. Ablation Site Changes - Amplitude of Signals

    Time frame: This will be assessed during the procedure.

    Characterization of amplitude signals at sites with HFS responses and successful HFS elimination

  4. Ablation Site Changes - Duration of Signals

    Time frame: This will be assessed during the procedure.

    Characterization of duration of signals at sites with HFS responses and successful HFS elimination

  5. Ablation Site Changes - Fractionation of Signals

    Time frame: This will be assessed during the procedure.

    Characterization of fractionation of signals at sites with HFS responses and successful HFS elimination

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 24, 2020
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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