Prospective Evaluation of CT Guided Ablation of Cardiac Ganglionated Plexi

NCT04642976 | Completed Results FDA Device

• 1 other identifier: 844182
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Ganglionated Plexus; Cardioneural Ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 Arms (1)

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

Interventions

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.

Also known as: Vagal stimulation using Parasym tragal stimulator

Atrial fibrillation ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with atrial fibrillation planned to undergo catheter ablation

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Timothy Markman
• Organization: University of Pennsylvania

timothy.markman@pennmedicine.upenn.edu

215-615-4332

Study Officials

• Saman Nazarian, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 24, 2020
• Study Start: January 20, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)