Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, Ganglionated Plexus, Cardioneural Ablation
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.
Interventions
DEVICEGanglionated 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.
Sponsors
University of Pennsylvania
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between HFS (High Frequency Stimulation) Response and CT Identified Epicardial Adipose Tissue. | During Procedure | Number of patients with HFS response identified within 3 pixels (0.625x3=1.875mm) of a location where CT identified epicardial adipose tissue. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HFS (High Frequency Stimulation) Response Elimination | during procedure | Elimination of local of HFS response following GP ablation |
| Global Vagal Response Elimination | This will be assessed during the procedure. | Elimination of global vagal response to non-invasive tragal stimulation |
| Ablation Site Changes - Amplitude of Signals | This will be assessed during the procedure. | Characterization of amplitude signals at sites with HFS responses and successful HFS elimination |
| Ablation Site Changes - Duration of Signals | This will be assessed during the procedure. | Characterization of duration of signals at sites with HFS responses and successful HFS elimination |
| Ablation Site Changes - Fractionation of Signals | This will be assessed during the procedure. | Characterization of fractionation of signals at sites with HFS responses and successful HFS elimination |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Atrial Fibrillation Ablation All patients undergoing ablation with undergo pre-procedural CT as well as HFS mapping and ablation of GPs.
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. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Atrial Fibrillation Ablation | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 26 Participants | — |
| Age, Categorical Between 18 and 65 years | 4 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 30 participants | — |
| Sex: Female, Male Female | 15 Participants | — |
| Sex: Female, Male Male | 15 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
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.
Time frame: During Procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atrial Fibrillation Ablation | Correlation Between HFS (High Frequency Stimulation) Response and CT Identified Epicardial Adipose Tissue. | 3 Number of patients with HFS response |
Secondary
Ablation Site Changes - Amplitude of Signals
Characterization of amplitude signals at sites with HFS responses and successful HFS elimination
Time frame: 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
Time frame: 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
Time frame: This will be assessed during the procedure.
Secondary
Global Vagal Response Elimination
Elimination of global vagal response to non-invasive tragal stimulation
Time frame: This will be assessed during the procedure.
Secondary
HFS (High Frequency Stimulation) Response Elimination
Elimination of local of HFS response following GP ablation
Time frame: during procedure