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low enrollment
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| Name | Class |
|---|---|
| Biosense Webster, Inc. | INDUSTRY |
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The goal of this trial is to test the impact of a step-wise approach for catheter ablation of recurrent ventricular tachycardia, (irregular heart rhythms that originate in the bottom chambers of the heart), in patients with a previous heart attack for whom catheter ablation is clinically indicated.
Sudden cardiac death due to VT (ventricular tachycardia) or VF (ventricular fibrillation) occurs at an estimated rate of 300,000 events per year in United States, accounting for 5.6% of annual mortality22. A significant proportion of patients treated with ICDs (implantable defibrillators) will receive shocks due to recurrent VT, resulting in increased mortality8. As a result, catheter-based ablation has emerged as an effective treatment for recurrent VT. However, no study has assessed the impact of a step-wise approach on the outcome of catheter ablation of VT. The investigators propose a prospective, multicenter, non-randomized, single-arm trial to evaluate the impact of a step-wise approach to catheter ablation on ventricular tachycardia recurrence. Given the increasing use of catheter ablation in patients with recurrent ventricular tachycardia, this study will answer a critical question regarding the impact of a step-wise approach on the inducibility of VT at the end of the procedure and clinical recurrences of ventricular arrhythmias at 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| catheter-based ablation | Other | catheter ablation - a medical procedure used to treat some types of arrhythmia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| catheter-based ablation | Procedure | specific electrophysiological and mapping techniques of activation and entrainment mapping during ongoing VT. Substrate mapping and ablation (substrate modification.) catheter ablation - a medical procedure used to treat some types of arrhythmia |
| Measure | Description | Time Frame |
|---|---|---|
| Catheter Ablation | The procedural efficacy as defined as acute success of a standardized step-wise approach for substrate-based catheter ablation of recurrent ventricular tachycardia in patients with coronary artery disease and prior ventricular tachycardia or appropriate therapy. Acute success will be defined as the ability to render VT non-inducible with a standardized complete stimulation protocol. catheter ablation - a medical procedure used to treat some types of arrhythmia | at time of catheter ablation procedure (intraoperative) |
| Measure | Description | Time Frame |
|---|---|---|
| ICD Interrogation | Chronic success will be defined as no recurrence of sustained VT or VT resulting in ICD therapies (ATP and/or ICD shocks) at 6 months follow-up as compared to baseline. | baseline and 6 months follow-up |
| Procedural Safety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vivek Reddy, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama - Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Loyola University |
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Patients were recruited from 12/2011 to 7/2013, at a medical clinic at MSSM.
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| ID | Title | Description |
|---|---|---|
| FG000 | Catheter-based Ablation | catheter ablation - a medical procedure used to treat some types of arrhythmia |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Catheter-based Ablation | catheter ablation - a medical procedure used to treat some types of arrhythmia |
| 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 | Catheter Ablation | The procedural efficacy as defined as acute success of a standardized step-wise approach for substrate-based catheter ablation of recurrent ventricular tachycardia in patients with coronary artery disease and prior ventricular tachycardia or appropriate therapy. Acute success will be defined as the ability to render VT non-inducible with a standardized complete stimulation protocol. catheter ablation - a medical procedure used to treat some types of arrhythmia | Given the small sample size, we did not analyze the data as there would be no statistical significance. | Posted | at time of catheter ablation procedure (intraoperative) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Catheter-based Ablation | catheter ablation - a medical procedure used to treat some types of arrhythmia |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hematuria | Renal and urinary disorders | Systematic Assessment |
Early termination due to poor enrollment. Data analysis not done - there is not enough data for meaningful analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vivek Y. Reddy | Icahn School of Medicine at Mount Sinai | 212-241-7114 | vivek.reddy@mountsinai.org |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
2) Procedural safety as defined by the number of complication within 1week associated with the procedure.
| 1 week post-op |
| Signal-Average ECG | Relationship between change in pre/post saECG and success of the step-wise ablation strategy | baseline and post-op day one after procedure |
| Maywood |
| Illinois |
| 60153 |
| United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Beth Israel-Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Hospital Regional Sao Jose | Santa Catarina | Brazil |
| Southlake Regional Health Center | Newmarket | Ontario | Canada |
| Homolka Hospital | Prague | Czechia |
| San Raffaele Hospital | Milan | Italy |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Secondary | ICD Interrogation | Chronic success will be defined as no recurrence of sustained VT or VT resulting in ICD therapies (ATP and/or ICD shocks) at 6 months follow-up as compared to baseline. | Not Posted | baseline and 6 months follow-up | Participants |
| Secondary | Procedural Safety | 2) Procedural safety as defined by the number of complication within 1week associated with the procedure. | Not Posted | 1 week post-op | Participants |
| Secondary | Signal-Average ECG | Relationship between change in pre/post saECG and success of the step-wise ablation strategy | Not Posted | baseline and post-op day one after procedure | Participants |
| 2 |
| 4 |
| 2 |
| 4 |
| pseudoaneurysm with hematoma | Blood and lymphatic system disorders | Systematic Assessment |
|
| pericardial effusion | Cardiac disorders | Systematic Assessment |
|
| fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| sustained Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
|
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| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |