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Contrast ICE for Myocardial Scar in VT Ablations

Primary Purpose

Ventricular Tachycardia, Ischemic Cardiomyopathy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Perflutren Lipid Microsphere Intravenous Suspension [DEFINITY]
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ventricular Tachycardia

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject is 18 years of age or older
  • Subject is undergoing catheter ablation of likely reentrant VT
  • Planned use of intracardiac echocardiography (ICE)
  • Subject is willing to sign and date the study informed consent form

Exclusion Criteria:

  • Contraindication to Perflutren (Optison) echo contrast
  • Known right-to-left, bidirectional, or transient right-to-left cardiac shunts
  • Known hypersensitivity to Perflutren, blood, blood products or albumin
  • Subject has medical condition that would limit study participation (as per MD discretion)
  • Subject is pregnant
  • Inability to give informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Definity

    Arm Description

    Perflutren echo contrast is infused to enhance intracardiac echo imaging recorded during catheter ablation of ventricular tachycardia. We will compare areas that appear to be myocardial scar on ultrasound with areas of abnormal electrical signals obtained by direct catheter mapping.

    Outcomes

    Primary Outcome Measures

    Number of Subjects With Myocardial Scar on Echo and Voltage Maps
    location of left ventricular myocardial scar and abnormal electrograms

    Secondary Outcome Measures

    Number of Subjects With Ventricular Tachycardia Mapped
    If ventricular tachycardia was induced and mapped then this counts as yes

    Full Information

    First Posted
    July 6, 2017
    Last Updated
    May 31, 2019
    Sponsor
    Weill Medical College of Cornell University
    Collaborators
    Biosense Webster, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03212326
    Brief Title
    Contrast ICE for Myocardial Scar in VT Ablations
    Official Title
    Contrast Enhanced Intracardiac Echocardiography (ICE) for Localization of Myocardial Scar During Ablation of Ventricular Tachycardia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2013 (Actual)
    Primary Completion Date
    September 2018 (Actual)
    Study Completion Date
    December 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Weill Medical College of Cornell University
    Collaborators
    Biosense Webster, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    There is a high correlation between scar areas identified by contrast-enhanced ICE and scar areas identified by conventional electroanatomic mapping. Therefore, the investigators will assess the utility of contrast-enhanced ICE to identify and localize myocardial scar real-time during VT ablation procedures.
    Detailed Description
    Ventricular tachycardia (VT) is a life-threatening arrhythmia which occurs frequently in the setting of structural heart disease, most often as result of myocardial fibrosis or scar. Catheter ablation is often performed to treat recurrent VT, but is predicated on precise localization of myocardial scar, as scar is often the source of VT. Currently during VT ablation procedures the identification of scar is based on electroanatomic mapping where bipolar voltage criteria have been established (i.e., bipolar electrogram voltage < 1.5 mV is considered scar). However this definition is purely based on electrical signal information and so has significant limitations: 1) there has not been definitive establishment of the sensitivity and specificity of this threshold for defining scar in comparison with tissue; 2) a detailed 3-D map created by time-consuming movement of the mapping catheter must be obtained in order to assess the existence and location of the scar; 3) only scar on the surface in contact with the mapping catheter (most often endocardial) may be definitively identified, whereas there may be intramyocardial or epicardial scar that would not be identified unless the mapping catheter makes direct contact with those areas which may involve additional risky access (epicardial) or even impossible (intramyocardial). For these reasons it would be very helpful to have another method to identify and localize myocardial scar during a VT ablation procedure. Cardiac MRI has been validated for identifying and localizing scar, but would not be recommended for many patients due to presence of ICD (implantable cardioverter-defibrillator) devices in these patients. Contrast-enhanced echocardiography has been validated to identify myocardial scar (Montant 2010), and intracardiac echocardiography (ICE) is standardly used in VT ablation procedures. Therefore, the investigators will assess the utility of contrast enhanced ICE by identifying and localizing myocardial scar real-time during VT ablation procedures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ventricular Tachycardia, Ischemic Cardiomyopathy

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Definity
    Arm Type
    Experimental
    Arm Description
    Perflutren echo contrast is infused to enhance intracardiac echo imaging recorded during catheter ablation of ventricular tachycardia. We will compare areas that appear to be myocardial scar on ultrasound with areas of abnormal electrical signals obtained by direct catheter mapping.
    Intervention Type
    Drug
    Intervention Name(s)
    Perflutren Lipid Microsphere Intravenous Suspension [DEFINITY]
    Intervention Description
    Perflutren 1.3mL diluted in 50 mL is infused intravenously, and intracardiac echo imaging is recorded to analyze for areas of possible myocardial scar, which is then compared with areas of abnormal electrical signal via direct catheter mapping which is performed during ablation of ventricular tachycardia.
    Primary Outcome Measure Information:
    Title
    Number of Subjects With Myocardial Scar on Echo and Voltage Maps
    Description
    location of left ventricular myocardial scar and abnormal electrograms
    Time Frame
    day 0 (intraoperative: data collected during the mapping procedure)
    Secondary Outcome Measure Information:
    Title
    Number of Subjects With Ventricular Tachycardia Mapped
    Description
    If ventricular tachycardia was induced and mapped then this counts as yes
    Time Frame
    day 0 (intraoperative: data collected during the mapping procedure)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject is 18 years of age or older Subject is undergoing catheter ablation of likely reentrant VT Planned use of intracardiac echocardiography (ICE) Subject is willing to sign and date the study informed consent form Exclusion Criteria: Contraindication to Perflutren (Optison) echo contrast Known right-to-left, bidirectional, or transient right-to-left cardiac shunts Known hypersensitivity to Perflutren, blood, blood products or albumin Subject has medical condition that would limit study participation (as per MD discretion) Subject is pregnant Inability to give informed consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christopher Liu, MD
    Organizational Affiliation
    Weill Medical College of Cornell University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Contrast ICE for Myocardial Scar in VT Ablations

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