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Prospective Evaluation of CT Guided Ablation of Cardiac Ganglionated Plexi

Sponsor
University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT04642976
Collaborator
(none)
16
Enrollment
2
Locations
60.4
Anticipated Duration (Months)
8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Ganglionated Plexi mapping and ablation using Natus Cortical Stimulator and standard ablation catheters

Study Design

Study Type:
Observational
Anticipated Enrollment :
16 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Evaluation of Computed Tomography Guided Ablation of Cardiac Ganglionated Plexi in Patients With Atrial Fibrillation
Actual Study Start Date :
Jan 20, 2021
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Feb 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Atrial fibrillation ablation

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
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between HFS (high frequency signals) and CT identified epicardial adipose tissue. [During Procedure]

      Correlation will be defined by sites being found within 3 pixels (0.625x3=1.875mm).

    Secondary Outcome Measures

    1. HFS (high frequency stimulation) response elimination [during procedure]

      Elimination of local of HFS response following GP ablation

    2. Global vagal response elimination [This will be assessed during the procedure.]

      Elimination of global vagal response to non-invasive tragal stimulation

    3. 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

    4. 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

    5. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Exclusion Criteria:

    1. Contraindication or unwillingness to undergo CT imaging or catheter ablation.

    2. Pregnancy or lactation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
    2 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • University of Pennsylvania

    Investigators

    • Principal Investigator: Saman Nazarian, MD, PhD, University of Pennsylvania

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT04642976
    Other Study ID Numbers:
    • 844182
    First Posted:
    Nov 24, 2020
    Last Update Posted:
    Feb 23, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by University of Pennsylvania
    Atrial Fibrillation
    Ganglionated Plexus
    Cardioneural Ablation
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    No Results Posted as of Feb 23, 2022