Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia (CEASE-VT)
This study has been terminated.
(Anticipated non-feasibility of recruitment objectives)
Sponsor:
Population Health Research Institute
Collaborators:
St. Jude Medical
Hamilton Health Sciences Corporation
Information provided by:
Population Health Research Institute
ClinicalTrials.gov Identifier:
NCT01097330
First received: March 31, 2010
Last updated: August 4, 2011
Last verified: August 2011
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Purpose
Implantable Cardioverter Defibrillators (ICDs) provide a shock or pacing therapy to bring back a normal heart beat when a patient experiences a dangerous abnormal heart rhythm such as ventricular tachycardia (VT). ICDs are very successful in bringing back a normal heart beat when VT occurs, but they do not prevent further dangerous heart rhythms from occurring. This study is designed to determine the best way to manage patients who have an ICD and who continue to have episodes of VT. There are two methods for treatment the VT: 1) Ablation, and 2) Medication.
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Defibrillators, Implantable Tachycardia, Ventricular |
Procedure: Ablation Drug: Amiodarone |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia: A Multi-center Randomized Trial |
Resource links provided by NLM:
Further study details as provided by Population Health Research Institute:
Primary Outcome Measures:
- Composite outcome-time to first occurrence of any of: 1. Appropriate ICD Therapy 2. Slow VT below ICD detection threshold leading to hospitalization or necessitates antiarrhythmics and/or ablation 3. Sudden Cardiac Death [ Time Frame: follow-up visits every 3 months until a common, event-driven study end date (up to 48 months) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- composite of: a. Ablation or amiodarone complications b. Inappropriate shocks from ICD c. Need for concomitant use of sotalol, dofetilide, azimilide or class I antiarrhythmic agents in either arm of the trial [ Time Frame: follow-up visits every 3 months until a common, event-driven study end date (up to 48 months) ] [ Designated as safety issue: Yes ]
- Quality of life score in each treatment arm using the EQ-5D questionnaire [ Time Frame: at one year ] [ Designated as safety issue: No ]
| Enrollment: | 12 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Ablation
Catheter based radiofrequency ablation for ischemic ventricular tachycardia
|
Procedure: Ablation
Catheter based radiofrequency ablation for ischemic ventricular tachycardia scheduled to occur within 4 weeks after randomization
Other Names:
|
|
Active Comparator: 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.
|
Drug: 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 Name: Cordarone
|
Eligibility| Ages Eligible for Study: | 19 Years to 84 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria - Patients must meet all of the following criteria:
- > 18 and < 85 years of age
- 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
- CAD with prior MI
- ICD or ECG documentation of ventricular arrhythmia responsible for appropriate ICD therapy [ATP & shocks].
Exclusion Criteria - Patients should not have any of the following criteria:
- Contraindication or allergy to contrast media, routine procedural medications or catheter materials
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097330
Locations
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Pennsylvania | |
| Hospital of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| Texas Cardiac Arrhythmia Research Foundation | |
| Austin, Texas, United States, 78705 | |
| United States, Virginia | |
| University of Virginia Health System | |
| Charlottesville, Virginia, United States, 22908 | |
| Canada, Ontario | |
| Hamilton Health Sciences | |
| Hamilton, Ontario, Canada, L8L 2X2 | |
| Southlake Regional Health Centre | |
| Newmarket, Ontario, Canada, L3Y 2P9 | |
| University of Ottawa Heart Institute | |
| Ottawa, Ontario, Canada, K1Y 4W7 | |
| Canada, Quebec | |
| McGill University Health Center | |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Canada | |
| Institut Universitaire de Cardiologie et Pneumologie de Québec | |
| Quebec, Canada, G1V 4G5 | |
| China | |
| Beijng Fuwai Heart Hospital | |
| Beijing, China, 100037 | |
Sponsors and Collaborators
Population Health Research Institute
St. Jude Medical
Hamilton Health Sciences Corporation
Investigators
| Principal Investigator: | Andrea Natale, M.D. | Texas Cardiac Arrhythmia Research Foundation |
| Principal Investigator: | David J Callans, M.D. | University of Pennsylvania |
| Principal Investigator: | Carlos A. Morillo, M.D. | Population Health Research Institute, McMaster University |
| Principal Investigator: | Girish M. Nair, M.D. | Population Health Research Institute, McMaster University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr. Carlos Morillo, Population Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT01097330 History of Changes |
| Other Study ID Numbers: | CEASE-VT |
| Study First Received: | March 31, 2010 |
| Last Updated: | August 4, 2011 |
| Health Authority: | Australia: Human Research Ethics Committee Canada: Ethics Review Committee China: Ethics Committee France: Institutional Ethical Committee Germany: Ethics Commission Italy: Ethics Committee South Korea: Institutional Review Board Spain: Ethics Committee Switzerland: Ethikkommission Taiwan: Institutional Review Board United Kingdom: Research Ethics Committee United States: Institutional Review Board |
Keywords provided by Population Health Research Institute:
|
Defibrillators, Implantable Tachycardia, Ventricular Catheter Ablation Amiodarone |
Additional relevant MeSH terms:
|
Tachycardia Tachycardia, Ventricular Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Amiodarone |
Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vasodilator Agents |
ClinicalTrials.gov processed this record on May 19, 2013