N/A
N=30
Prospective Evaluation of CT Guided Ablation of Cardiac Ganglionated Plexi
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT04642976 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Correlation Between HFS (High Frequency Stimulation) Response and CT Identified Epicardial Adipose Tissue. — 3 Number of patients with HFS response
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Ganglionated Plexi mapping and ablation using Natus Cortical Stimulator and standard ablation catheters (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation Between HFS (High Frequency Stimulation) Response and CT Identified Epicardial Adipose Tissue. |
3 | — |
| SECONDARY HFS (High Frequency Stimulation) Response Elimination |
— | — |
| SECONDARY Global Vagal Response Elimination |
— | — |
| SECONDARY Ablation Site Changes - Amplitude of Signals |
— | — |
| SECONDARY Ablation Site Changes - Duration of Signals |
— | — |
| SECONDARY Ablation Site Changes - Fractionation of Signals |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Contraindication or unwillingness to undergo CT imaging or catheter ablation.
- Pregnancy or lactation
Data sourced from ClinicalTrials.gov (NCT04642976). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.