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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atrial fibrillation ablation | All patients undergoing ablation with undergo pre-procedural CT as well as HFS mapping and ablation of GPs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| HFS (High Frequency Stimulation) Response Elimination | Elimination of local of HFS response following GP ablation | during procedure |
| Global Vagal Response Elimination | Elimination of global vagal response to non-invasive tragal stimulation |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with atrial fibrillation planned to undergo catheter ablation
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| Name | Affiliation | Role |
|---|---|---|
| Saman Nazarian, MD, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
No individual participant data will be shared with other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | Number of patients with HFS response | During Procedure |
|
24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timothy Markman | University of Pennsylvania | 215-615-4332 | timothy.markman@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 24, 2021 | Apr 11, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
|
| This will be assessed during the procedure. |
| 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. |
| 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. |
| 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. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | HFS (High Frequency Stimulation) Response Elimination | Elimination of local of HFS response following GP ablation | Not Posted | during procedure | Participants |
| Secondary | Global Vagal Response Elimination | Elimination of global vagal response to non-invasive tragal stimulation | Not Posted | This will be assessed during the procedure. | Participants |
| Secondary | Ablation Site Changes - Amplitude of Signals | Characterization of amplitude signals at sites with HFS responses and successful HFS elimination | Not Posted | This will be assessed during the procedure. | Participants |
| Secondary | Ablation Site Changes - Duration of Signals | Characterization of duration of signals at sites with HFS responses and successful HFS elimination | Not Posted | This will be assessed during the procedure. | Participants |
| Secondary | Ablation Site Changes - Fractionation of Signals | Characterization of fractionation of signals at sites with HFS responses and successful HFS elimination | Not Posted | This will be assessed during the procedure. | Participants |
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |