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The purpose of this study is to determine if early ablation (i.e., ablation of ventricular tachycardia in patients with infrequent VT episodes) is more effective than medical therapy alone for the treatment of ischemic ventricular tachycardia in patients with Implantable Cardioverter Defibrillators (ICDs) who continue to have episodes of ventricular tachycardia despite drug therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Active Comparator | This group receives radiofrequency catheter ablation and drug treatment. |
|
| Control Group | Experimental | This group receives only drug treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug Treatment | Drug | Class I and III antiarrhythmic drug treatment. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who Had Hospitalization for Ventricular Tachycardia (VT) Related Causes/Events | The hospital admission date must occur after completing the 1-month follow-up visit for the event to be considered an effectiveness failure. | From one month to 2 years follow up |
| Cardiac-related Death | Subjects with cardiac-related death | 2 years follow up |
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Inclusion Criteria:
Subject must be drug refractory on Class I-IV AADs (i.e., having VT episodes despite drug therapy)
a. Subject must be on at least one AAD at time of enrollment
Qualifying episode must be sustained, monomorphic Ventricular Tachycardia post myocardial infarction
ICD implanted
1 to 3 sustained monomorphic VT episodes requiring appropriate therapy within the previous six (6) months as determined by the investigator
History of myocardial infarction documented by the development of pathological Q waves with or without symptoms, imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract in the absence of a nonischemic cause, or pathological findings of a healed or healing myocardial infarction
18 years or older
Able and willing to comply with all pre- and follow-up testing and requirements
Signed Informed Consent Form
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Callans, MD | University of Pennsylvania | Study Chair |
| Francis Marchlinski, MD | University of Pennsylvania | Study Chair |
| Andrea Natale, MD | Texas Cardiac Arrhythmia Research Foundation | Study Chair |
| Vivek Reddy, MD | Icahn School of Medicine at Mount Sinai | Study Chair |
| David Wilber, MD | Loyola University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States | ||
| California Pacific Medical Center |
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The first and the last subject were enrolled on July 9, 2012 and on January 30, 2014 respectively. All ASPIRE sites were notified that the study was terminated due to ongoing enrollment issues on March 10, 2014. A total of 21 US study sites were activated with 7 sites enrolling subjects. The last follow-up visit was completed on April 21, 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Catheter Ablation Group | Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Catheter Ablation |
| Device |
Radiofrequency catheter ablation and Class I and III antiarrhythmic drug treatment. |
|
| San Francisco |
| California |
| 94115 |
| United States |
| San Francisco VA Medical Center | San Francisco | California | 94121 | United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| University of Colorado, Denver | Aurora | Colorado | 80045 | United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| Loyola University Chicago | Maywood | Illinois | 60153 | United States |
| Central Baptist Hospital | Lexington | Kentucky | 40503 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02199 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Mayo Clinic | Rochester | Minnesota | 55902 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Columbia University- New York Presbyterian Hospital | New York | New York | 10032 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| University of Oklahoma | Oklahoma City | Oklahoma | 73104 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705 | United States |
| St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| FG001 |
| Drug Treatment Group |
Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator. |
| COMPLETED |
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| NOT COMPLETED |
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|
All enrolled subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | Catheter Ablation Group | Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator. |
| BG001 | Drug Treatment Group | Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Percentage of Subjects Who Had Hospitalization for Ventricular Tachycardia (VT) Related Causes/Events | The hospital admission date must occur after completing the 1-month follow-up visit for the event to be considered an effectiveness failure. | All enrolled subjects | Posted | Number | percentage of participants | From one month to 2 years follow up |
|
|
| |||||||||||||||||||||||||||||
| Primary | Cardiac-related Death | Subjects with cardiac-related death | All enrolled subjects | Posted | Number | percentage of participants | 2 years follow up |
|
|
During the 3-year follow-up after the ablation procedure.
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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 Ablation Group | Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator. | 3 | 9 | 3 | 9 | ||
| EG001 | Drug Treatment Group | Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator. | 4 | 6 | 3 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart Failure | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Congestive Heart Failure | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Ventricular Tachycardia | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Deep Venous Thrombosis Distal | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Adenocarcinoma Lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart Failure | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Ventricular Fibrillation | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Ventricular Tachycardia | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Ventricular Tachyarrhythmia | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Intracardiac Thrombus | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Chronotropic Incompetence | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Neurological Symptom | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Medical Device Removal | Surgical and medical procedures | MedDRA (13.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Deep Venous Thrombosis NOS | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pseudomonas Infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Obstructive Sleep Apnea Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
Please note that this study was terminated early and only 15 subjects were enrolled. As a result the reported results might be unreliable (unmonitored) and limited.
There IS an agreement between the Principal Investigator (PI)/Institution and the Sponsor (or its agents) that restricts the PI's rights to discuss, present or publish trial results after the trial is completed. Please contact Biosense Webster, Inc. for additional information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Cropper, Manager, Clinical Operations | Biosense Webster, Inc. | (800) 729-9010 | 8607 | Kcropper@its.jnj.com |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|
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