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Utilizing a Novel Method to Map Sources of Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MRI
ECG
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female, At least 21 years of age.
  • Subjects with persistent AF undergoing a first catheter ablation procedure.

Exclusion Criteria:

  • Inability to sign consent.
  • Patients with a life expectancy <1 year.
  • Previous ablation of the atria
  • Pregnant women and women that are breast feeding.
  • Subjects with contraindication to MRI such as cochlear implants, ocular foreign body (e.g. metal shavings), brain aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker or defibrillator.
  • Subjects with a history of kidney problems (GFR < 30m/min) or have had a kidney and/or liver transplant in the past 4 weeks will be excluded from the study or undergo the MRI exam without the use of a contrast agent, per standard MR exclusion criteria.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Recurrence Mapping

    Arm Description

    Participant undergoing their first ablation that fit our inclusion/exclusion criteria will undergo new atrial fibrillation mapping techniques to help identify the sources of atrial fibrillation. The participant will have an MRI and ECG prior to a clinically indicated ablation.

    Outcomes

    Primary Outcome Measures

    Utilize MRI and ECG to map electrogram morphology recurrence in participants with Atrial Fibrillation undergoing an ablation procedure.
    The MRI data captured will be used to calculate geometric wall stress and quantify fibrosis. The ECG will allow for a frequency domain analysis to estimate atrial rate and organization of atrial activity during atrial fibrillation. Together MRI and ECG data will provide a detailed map of electrogram morphology.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 5, 2015
    Last Updated
    September 20, 2016
    Sponsor
    Northwestern University
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02523534
    Brief Title
    Utilizing a Novel Method to Map Sources of Atrial Fibrillation
    Official Title
    Pathophysiological Significance of Atrial Fibrillation Electrogram Patterns
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    August 2020 (Anticipated)
    Study Completion Date
    August 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Northwestern University
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is an electrogram mapping study that tests the ability of a new signal processing technique called electrogram morphology recurrence mapping to locate drivers in participants with atrial fibrillation. This study will also test the hypothesis that there are non-invasive markers that can predict driver location. Electrogram mapping will be performed in participants undergoing ablation for persistent atrial fibrillation. These participants will have a cardiac MRI and 12-lead ECG prior to the ablation procedure.
    Detailed Description
    Atrial fibrillation (AF) has been described as a new emerging epidemic currently affecting around 1% of the population. Risk of AF increases with age and as the elderly continue to comprise a larger percentage of the population in the United States, the health burden of AF continues to increase. Some estimates project nearly 16 million cases of AF in the US alone by 2050. The economic burden of AF has been estimated to be between $6-26 billion. AF is a significant risk factor for stroke if left untreated as well as mortality. The diagnosis and treatment of AF have therefore become an important aspect of cardiovascular medicine. Current pharmacological treatments for AF have modest efficacy and suffer from potentially life-threatening side effects. Current ablative and surgical approaches to AF, though somewhat more successful, use an anatomic, 'one-size fits all' strategy (with some minor variations) that does not address the specific mechanisms underlying this complex arrhythmia. The pulmonary veins have been shown to be a common location of AF triggers. Thus, the most common approach for catheter ablation involves the isolation of the pulmonary veins, such as the wide area circumferential pulmonary vein ablation strategy. The lack of consideration of specific sources may be, at least in part, responsible for post- ablation arrhythmias occurring in up to 40% of patients who undergo pulmonary vein ablation. However, while ablation/surgical success has been shown to increase with more extensive ablation/surgery in the atria, the latter comes at the cost of significant "collateral damage" to the atrial myocardium as well as to surrounding structures, with an accompanying increase in the risk of complications and a decrease in atrial function. The time and cost to perform these procedures is also significant. Thus, catheter and surgical ablation strategies tailored to the specific arrhythmia origin of a patient's AF would have a significant impact on the ability to treat this arrhythmia. The investigator's laboratory has developed a novel electrogram morphology recurrence analysis to observe the nonlinear dynamics of AF activation. This technique to map AF activation is based on the hypothesis that AF electrograms with morphologies that are highly recurrent and that have short cycle lengths represent the locations of stable AF sources. The investigator's preliminary data show that when the highest recurrence percentage or shortest recurrence cycle length occurs in the left atrium in patients undergoing pulmonary vein-based ablation, the patients has a much higher chance to stay in sinus rhythm post-ablation than when the highest recurrence percentage or shortest recurrence cycle length occur in the right atrium. Cycle length of all activations was not a predictor of outcomes. High resolution electrical mapping of AF in the canine atria showed that the shortest recurrence cycle length sites correspond to areas containing rotors. Thus, these preliminary data provide strong evidence that morphology recurrence mapping is able to identify the locations of AF sources.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Recurrence Mapping
    Arm Type
    Experimental
    Arm Description
    Participant undergoing their first ablation that fit our inclusion/exclusion criteria will undergo new atrial fibrillation mapping techniques to help identify the sources of atrial fibrillation. The participant will have an MRI and ECG prior to a clinically indicated ablation.
    Intervention Type
    Procedure
    Intervention Name(s)
    MRI
    Other Intervention Name(s)
    Magnetic Resonance Imagining
    Intervention Description
    MRI images will be taken in conjunction with the clinically indicated cardiac MRI.
    Intervention Type
    Procedure
    Intervention Name(s)
    ECG
    Other Intervention Name(s)
    Electrocardiogram
    Intervention Description
    ECG readings will be taken prior to the participants clinically indicated procedure.
    Primary Outcome Measure Information:
    Title
    Utilize MRI and ECG to map electrogram morphology recurrence in participants with Atrial Fibrillation undergoing an ablation procedure.
    Description
    The MRI data captured will be used to calculate geometric wall stress and quantify fibrosis. The ECG will allow for a frequency domain analysis to estimate atrial rate and organization of atrial activity during atrial fibrillation. Together MRI and ECG data will provide a detailed map of electrogram morphology.
    Time Frame
    4 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male and female, At least 21 years of age. Subjects with persistent AF undergoing a first catheter ablation procedure. Exclusion Criteria: Inability to sign consent. Patients with a life expectancy <1 year. Previous ablation of the atria Pregnant women and women that are breast feeding. Subjects with contraindication to MRI such as cochlear implants, ocular foreign body (e.g. metal shavings), brain aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker or defibrillator. Subjects with a history of kidney problems (GFR < 30m/min) or have had a kidney and/or liver transplant in the past 4 weeks will be excluded from the study or undergo the MRI exam without the use of a contrast agent, per standard MR exclusion criteria.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jason Ng, PhD
    Organizational Affiliation
    Northwestern University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Utilizing a Novel Method to Map Sources of Atrial Fibrillation

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