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
About this trial
This is an interventional diagnostic trial for Ventricular Tachycardia
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
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
NCT ID
NCT03212326
First Posted
July 6, 2017
Last Updated
May 31, 2019
Sponsor
Weill Medical College of Cornell University
Collaborators
Biosense Webster, Inc.
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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