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Prospective Evaluation of CT Guided Ablation of Cardiac Ganglionated Plexi

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04642976
Recruitment Status : Recruiting
First Posted : November 24, 2020
Last Update Posted : February 23, 2022
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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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.

Condition or disease Intervention/treatment
Atrial Fibrillation Device: Ganglionated Plexi mapping and ablation using Natus Cortical Stimulator and standard ablation catheters

Study Design
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Study Type : Observational
Estimated Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of Computed Tomography Guided Ablation of Cardiac Ganglionated Plexi in Patients With Atrial Fibrillation
Actual Study Start Date : January 20, 2021
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : February 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Atrial fibrillation ablation
All patients undergoing ablation with undergo pre-procedural CT as well as HFS mapping and ablation of GPs.
 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.
Other Name: Vagal stimulation using Parasym tragal stimulator


Outcome Measures
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Primary Outcome Measures :
  1. Correlation between HFS (high frequency signals) and CT identified epicardial adipose tissue. [ Time Frame: During Procedure ]
    Correlation will be defined by sites being found within 3 pixels (0.625x3=1.875mm).


Secondary Outcome Measures :
  1. HFS (high frequency stimulation) response elimination [ Time Frame: during procedure ]
    Elimination of local of HFS response following GP ablation

  2. Global vagal response elimination [ Time Frame: This will be assessed during the procedure. ]
    Elimination of global vagal response to non-invasive tragal stimulation

  3. Ablation site changes - amplitude of signals [ Time Frame: This will be assessed during the procedure. ]
    Characterization of amplitude signals at sites with HFS responses and successful HFS elimination

  4. Ablation site changes - duration of signals [ Time Frame: This will be assessed during the procedure. ]
    Characterization of duration of signals at sites with HFS responses and successful HFS elimination

  5. Ablation site changes - fractionation of signals [ Time Frame: This will be assessed during the procedure. ]
    Characterization of fractionation of signals at sites with HFS responses and successful HFS elimination


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with atrial fibrillation planned to undergo catheter ablation
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04642976


Contacts
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Contact: Timothy M Markman, MD 2675930103 timothy.markman@pennmedicine.upenn.edu
Contact: Saman Nazarian, MD, PhD 215-615-5219 Saman.Nazarian@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
Hospital of the University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Timothy Markman, MD         
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Saman Nazarian, MD, PhD    215-615-5219    Saman.Nazarian@pennmedicine.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Saman Nazarian, MD, PhD University of Pennsylvania
More Information
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04642976    
Other Study ID Numbers: 844182
First Posted: November 24, 2020    Key Record Dates
Last Update Posted: February 23, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of Pennsylvania:
Atrial Fibrillation
Ganglionated Plexus
Cardioneural Ablation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes