Atrial FibrillationNCT04642976
Prospective Evaluation of CT Guided Ablation of Cardiac Ganglionated Plexi
An observational study of Atrial Fibrillation, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Ganglionated Plexi mapping and ablation using Natus Cortical Stimulator and standard ablation catheters
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2021to 1 Jan 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with atrial fibrillation planned to undergo catheter ablation
Who may be able to join
- 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
Who cannot join
- Contraindication or unwillingness to undergo CT imaging or catheter ablation.
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Prospective Evaluation of Computed Tomography Guided Ablation of Cardiac Ganglionated Plexi in Patients With Atrial Fibrillation
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.
- Conditions
- Atrial Fibrillation
- Being tested
- Ganglionated Plexi mapping and ablation using Natus Cortical Stimulator and standard ablation catheters
- Keywords
- Atrial Fibrillation, Ganglionated Plexus, Cardioneural Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ganglionated Plexi mapping and ablation using Natus Cortical Stimulator and standard ablation cathetersDevice
Also called Vagal stimulation using Parasym tragal stimulator
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.
| Study group | Role | What they receive |
|---|---|---|
| Atrial fibrillation ablation | All patients undergoing ablation with undergo pre-procedural CT as well as HFS mapping and ablation of GPs. Receives: Device: Ganglionated Plexi mapping and ablation using Natus Cortical Stimulator and standard ablation catheters |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During Procedure
Secondary outcomes (5)
HFS (High Frequency Stimulation) Response Elimination
Elimination of local of HFS response following GP ablation
Measured: during procedure
Global Vagal Response Elimination
Elimination of global vagal response to non-invasive tragal stimulation
Measured: 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
Measured: 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
Measured: 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
Measured: This will be assessed during the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start20 Jan 2021
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saman Nazarian, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642976
- Sponsor's protocol ID
- 844182
- Status last verified
- Oct 2024
- First submitted
- 13 Nov 2020
- Last updated
- 15 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No individual participant data will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Computed Tomography Guided Ablation of Cardiac Ganglionated Plexi in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04642976
- Acronym / sponsor ID
- 844182
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Ganglionated Plexus, Cardioneural Ablation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 24 Nov 2020 (actual)
- Results
- Posted 15 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atrial fibrillation ablation | – | Device: Ganglionated Plexi mapping and ablation using Natus Cortical Stimulator and standard ablation cathetersAll patients undergoing ablation with undergo pre-procedural CT as well as HFS mapping and ablation of GPs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with atrial fibrillation planned to undergo catheter ablation
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Contraindication or unwillingness to undergo CT imaging or catheter ablation.
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ganglionated Plexi mapping and ablation using Natus Cortical Stimulator and standard ablation cathetersAlso: Vagal stimulation using Parasym tragal stimulatorGanglionated 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. | Device | Atrial fibrillation ablation |
Primary outcome
Correlation Between HFS (High Frequency Stimulation) Response and CT Identified Epicardial Adipose Tissue.
Time frame: 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.
5 secondary outcomes
HFS (High Frequency Stimulation) Response Elimination
Time frame: during procedure
Global Vagal Response Elimination
Time frame: This will be assessed during the procedure.
Ablation Site Changes - Amplitude of Signals
Time frame: This will be assessed during the procedure.
Ablation Site Changes - Duration of Signals
Time frame: This will be assessed during the procedure.
Ablation Site Changes - Fractionation of Signals
Time frame: This will be assessed during the procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No individual participant data will be shared with other researchers.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saman Nazarian, MD, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between HFS (High Frequency Stimulation) Response and CT Identified Epicardial Adipose Tissue. (time frame: During Procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.