Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Biosense Webster, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Ventricular Tachycardia Mapped | If ventricular tachycardia was induced and mapped then this counts as yes | day 0 (intraoperative: data collected during the mapping procedure) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christopher Liu, MD | Weill Medical College of Cornell University | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients recruited from hospital inpatient ward and from electrophysiology laboratory procedure suites. Recruitment commenced March 2013, and ended March 2016.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Myocardial Scar on Echo and Voltage Maps | location of left ventricular myocardial scar and abnormal electrograms | 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. | Posted | Count of Participants | Participants | day 0 (intraoperative: data collected during the mapping procedure) |
|
1 day
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christopher Liu | Weill Cornell Medical College | 212-746-2655 | chl7001@med.cornell.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2013 | May 3, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C042852 | perflutren |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| left ventricular ejection fraction among subjects | Median | Inter-Quartile Range | percent |
|
| number of subjects with hypertension | Count of Participants | Participants |
|
| number of subjects with implanted defibrillator | Count of Participants | Participants |
|
| number of subjects with ischemic cardiomyopathy | Count of Participants | Participants |
|
|
|
| Secondary | Number of Subjects With Ventricular Tachycardia Mapped | If ventricular tachycardia was induced and mapped then this counts as yes | 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. | Posted | Count of Participants | Participants | day 0 (intraoperative: data collected during the mapping procedure) |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
Not provided
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |