N/A
N=24
Contrast ICE for Myocardial Scar in VT Ablations
Ventricular Tachycardia · Ischemic Cardiomyopathy
Bottom Line
View on ClinicalTrials.gov: NCT03212326 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Number of Subjects With Myocardial Scar on Echo and Voltage Maps — 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Perflutren Lipid Microsphere Intravenous Suspension [DEFINITY] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Myocardial Scar on Echo and Voltage Maps |
20 | — |
| SECONDARY Number of Subjects With Ventricular Tachycardia Mapped |
20 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03212326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.