Contrast ICE for Myocardial Scar in VT Ablations

NCT03212326 | Completed Results

• 1 other identifier: 1205012398
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ventricular Tachycardia; Ischemic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Myocardial Scar on Echo and Voltage Maps

  location of left ventricular myocardial scar and abnormal electrograms

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

Secondary Outcomes (1)

• Number of Subjects With Ventricular Tachycardia Mapped

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

Study Arms (1)

Definity

EXPERIMENTAL

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.

Drug: Perflutren Lipid Microsphere Intravenous Suspension [DEFINITY]

Interventions

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.

Definity

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Biosense Webster, Inc.: collaborator

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

perflutren

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Christopher Liu
• Organization: Weill Cornell Medical College

chl7001@med.cornell.edu

212-746-2655

Study Officials

• Christopher Liu, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 11, 2017
• Study Start: March 1, 2013
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 12, 2019
• Results First Posted: May 31, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share