CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Ganglionated Plexi mapping and ablation using Natus Cortical Stimulator and standard ablation cathetersdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04642976
NCT04642976N/ACompleted

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

University of Pennsylvania·observational·Posted Nov 24, 2020·Updated Oct 15, 2024

In Brief

An observational study evaluating Ganglionated Plexi mapping and ablation using Natus Cortical Stimulator and standard ablation catheters for Atrial Fibrillation. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedNov 24, 2020
Enrollment StartJan 20, 2021
Primary CompletionJan 1, 2024
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 5.6 years ago

Interventions

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

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.