Prospective Evaluation of CT Guided Ablation of Cardiac Ganglionated Plexi

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04642976
• Other study ID #: 844182
• Status: Active, not recruiting
• Start date: January 20, 2021
• Est. completion date: February 2032

Study information

• Verified date: March 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: February 2032
• Est. primary completion date: January 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between HFS (high frequency signals) and CT identified epicardial adipose tissue.	Correlation will be defined by sites being found within 3 pixels (0.625x3=1.875mm).	During Procedure
Secondary	HFS (high frequency stimulation) response elimination	Elimination of local of HFS response following GP ablation	during procedure
Secondary	Global vagal response elimination	Elimination of global vagal response to non-invasive tragal stimulation	This will be assessed during the procedure.
Secondary	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.
Secondary	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.
Secondary	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.