Clinical trial NCT03212326: 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
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Tachycardia
Ischemic Cardiomyopathy
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
First posted: 2017-07-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Number of Subjects With Myocardial Scar on Echo and Voltage Maps
timeFrame: day 0 (intraoperative: data collected during the mapping procedure)
Secondary outcomes:
measure: Number of Subjects With Ventricular Tachycardia Mapped
timeFrame: day 0 (intraoperative: data collected during the mapping procedure)
Other outcomes:
Locations:
Study officials:
affiliation: Weill Medical College of Cornell University
name: Christopher Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: