Prospective Evaluation of CT Guided Ablation of Cardiac Ganglionated Plexi

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Ganglionated Plexi mapping and ablation using Natus Cortical Stimulator and standard ablation catheters

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients with atrial fibrillation planned to undergo catheter ablation

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2021
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): November 24, 2020

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Ganglionated Plexus; Cardioneural Ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 844182

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared with other researchers.

Drug and device information, study documents

• 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