Trial Outcomes & Findings for Contrast ICE for Myocardial Scar in VT Ablations (NCT NCT03212326)
NCT ID: NCT03212326
Last Updated: 2019-06-12
Results Overview
location of left ventricular myocardial scar and abnormal electrograms
COMPLETED
NA
24 participants
day 0 (intraoperative: data collected during the mapping procedure)
2019-06-12
Participant Flow
Patients recruited from hospital inpatient ward and from electrophysiology laboratory procedure suites. Recruitment commenced March 2013, and ended March 2016.
Participant milestones
| Measure |
Definity
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.
Perflutren Lipid Microsphere Intravenous Suspension \[DEFINITY\]: 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.
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|---|---|
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Overall Study
STARTED
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24
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Overall Study
COMPLETED
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20
|
|
Overall Study
NOT COMPLETED
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4
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Reasons for withdrawal
| Measure |
Definity
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.
Perflutren Lipid Microsphere Intravenous Suspension \[DEFINITY\]: 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.
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|---|---|
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Overall Study
Physician Decision
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4
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Definity
n=24 Participants
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.
Perflutren Lipid Microsphere Intravenous Suspension \[DEFINITY\]: 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.
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|---|---|
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Age, Continuous
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66.6 years
STANDARD_DEVIATION 10.1 • n=24 Participants
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|
Sex: Female, Male
Female
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2 Participants
n=24 Participants
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Sex: Female, Male
Male
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22 Participants
n=24 Participants
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Region of Enrollment
United States
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24 participants
n=24 Participants
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left ventricular ejection fraction among subjects
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25 percent
n=24 Participants
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|
number of subjects with hypertension
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10 Participants
n=24 Participants
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number of subjects with implanted defibrillator
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21 Participants
n=24 Participants
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number of subjects with ischemic cardiomyopathy
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18 Participants
n=24 Participants
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PRIMARY outcome
Timeframe: day 0 (intraoperative: data collected during the mapping procedure)Population: 3 of 24 enrolled subjects did not have voltage mapping, and 1 of 24 subjects did not have echo contrast injection; thus a total of 4 subjects did not have both echo contrast and voltage mapping in order to allow scar comparison; therefore the 20 subjects with complete echo and voltage maps were analyzed.
location of left ventricular myocardial scar and abnormal electrograms
Outcome measures
| Measure |
Definity
n=20 Participants
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.
Perflutren Lipid Microsphere Intravenous Suspension \[DEFINITY\]: 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.
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|---|---|
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Number of Subjects With Myocardial Scar on Echo and Voltage Maps
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20 Participants
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SECONDARY outcome
Timeframe: day 0 (intraoperative: data collected during the mapping procedure)Population: 4 of 24 enrolled subjects did not inducible ventricular tachycardia; thus a total of 4 subjects did not have both scar and ventricular tachycardia mapping in order to allow scar comparison; therefore the 20 subjects with complete scar and ventricular tachycardia maps were analyzed.
If ventricular tachycardia was induced and mapped then this counts as yes
Outcome measures
| Measure |
Definity
n=20 Participants
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.
Perflutren Lipid Microsphere Intravenous Suspension \[DEFINITY\]: 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.
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|---|---|
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Number of Subjects With Ventricular Tachycardia Mapped
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20 Participants
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Adverse Events
Definity
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60