Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia
NCT ID: NCT01097330
Last Updated: 2020-01-29
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
12 participants
INTERVENTIONAL
2010-08-31
2012-03-31
Brief Summary
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An ablation procedure involves placing a flexible catheter (insulated wire) in the groin area and threading it into the heart. After the doctor has located the affected area responsible for the VT, radiofrequency energy is delivered by the power generator through the catheter to the inside of the heart. The radiofrequency energy ablates (burns) a small area of the heart tissue thought to cause the VT.
A medication called Amiodarone is an "anti-arrhythmic" prescribed to prevent abnormal heart rhythms from recurring.
The purpose of this study is to compare these two different methods for treating VT. Treatment with ablation and amiodarone are both considered the standard of care for patients with VT but they have not been compared directly in a study like this before.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ablation
Catheter based radiofrequency ablation for ischemic ventricular tachycardia
Ablation
Catheter based radiofrequency ablation for ischemic ventricular tachycardia scheduled to occur within 4 weeks after randomization
Amiodarone
amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study.
Amiodarone
Amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study
Interventions
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Ablation
Catheter based radiofrequency ablation for ischemic ventricular tachycardia scheduled to occur within 4 weeks after randomization
Amiodarone
Amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ICD implanted for primary prophylaxis against sudden cardiac death or ICD implanted for secondary prophylaxis against spontaneous or inducible sustained VT without any reversible causes
* Coronary artery disease (CAD) with prior myocardial infarction (MI)
* ICD or electrocardiogram (ECG) documentation of ventricular arrhythmia responsible for appropriate ICD therapy \[antitachycardia pacing (ATP) \& shocks\].
Exclusion Criteria
* Contraindication to an interventional procedure
* Current or previous (within 3 months) amiodarone therapy
* Atrial Fibrillation requiring antiarrhythmic drug therapy
* Contraindication to amiodarone therapy
* New York Heart Association (NYHA) functional class IV
* Myocardial infarction within the past 60 days
* Stroke within the past 90 days
* Unstable angina
* Hypertrophic cardiomyopathy, Non-ischemic dilated cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Brugada Syndrome, Catecholamine sensitive polymorphic VT or long QT syndrome
* Patients with active ischemia that are eligible for revascularization
* Life expectancy less than 6 months
* Incessant or multiple episodes of VT requiring immediate therapy with medications or ablation
* Untreated hypothyroidism or hyperthyroidism. Patients who are euthyroid on thyroid hormone replacement therapy are acceptable.
* Current enrollment in another investigational drug or device study.
* Presence of any other condition that the investigator feels would be problematic or would restrict or limit the participation of the patient for the entire study period.
* Absolute contra-indication to the use of heparin and or warfarin.
* Documented intra-atrial thrombus, ventricular thrombus (\< 6 months after detection of thrombus), tumor, or another abnormality which precludes catheter introduction.
* Females of childbearing potential who are not practicing protocol acceptable method of birth control.
19 Years
84 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Hamilton Health Sciences Corporation
OTHER
Population Health Research Institute
OTHER
Responsible Party
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Principal Investigators
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Andrea Natale, M.D.
Role: PRINCIPAL_INVESTIGATOR
Texas Cardiac Arrhythmia Research Foundation
David J Callans, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Carlos A. Morillo, M.D.
Role: PRINCIPAL_INVESTIGATOR
Population Health Research Institute, McMaster University
Girish M. Nair, M.D.
Role: PRINCIPAL_INVESTIGATOR
Population Health Research Institute, McMaster University
Locations
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Northwestern University
Chicago, Illinois, United States
Mayo Clinic
Rochester, Minnesota, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Hamilton Health Sciences
Hamilton, Ontario, Canada
Southlake Regional Health Centre
Newmarket, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
McGill University Health Center
Montreal, Quebec, Canada
Institut Universitaire de Cardiologie et Pneumologie de Québec
Québec, , Canada
Beijng Fuwai Heart Hospital
Beijing, , China
Countries
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Related Links
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Population Health Research Institute
Other Identifiers
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CEASE-VT
Identifier Type: -
Identifier Source: org_study_id
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