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OpenTrials
Completed

NCT Number: NCT03212326

Contrast ICE for Myocardial Scar in VT Ablations

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Perflutren Lipid Microsphere Intravenous Suspension [DEFINITY]

Drug

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 outcomes

  1. Number of Subjects With Myocardial Scar on Echo and Voltage Maps

    Time frame: day 0 (intraoperative: data collected during the mapping procedure)

    location of left ventricular myocardial scar and abnormal electrograms

Secondary outcomes

  1. Number of Subjects With Ventricular Tachycardia Mapped

    Time frame: day 0 (intraoperative: data collected during the mapping procedure)

    If ventricular tachycardia was induced and mapped then this counts as yes

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Biosense Webster, Inc.

Registry information

Official study title

Contrast Enhanced Intracardiac Echocardiography (ICE) for Localization of Myocardial Scar During Ablation of Ventricular Tachycardia

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jul 11, 2017
Registry last updated
Jun 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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