CEASE-VT: Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Appropriate ICD Therapy, Slow VT or Sudden Cardiac Death [From 30 days following randomization until final follow-up visit]
Number of participants with a composite outcome of any of: Appropriate Implantable Cardioverter Defibrillator (ICD) therapy [Including antitachycardia pacing (ATP) and shocks] Slow ventricular tachycardia (VT) below ICD detection threshold leading to hospitalization or necessitates antiarrhythmic medications and/or catheter ablation Sudden Cardiac Death
Secondary Outcome Measures
- Number of Participants With (a) Ablation or Amiodarone Complications, (b) Inappropriate Shocks From ICD, or (c) Need for Concomitant Use of Sotalol, Dofetilide, Azimilide or Class 1 Antiarrhythmic Agents in Either Arm of the Trial. [from randomization until final follow-up]
Number of Participants with (a) Ablation or Amiodarone Complications, (b) Inappropriate Shocks from ICD, or (c) Need for Concomitant use of Sotalol, Dofetilide, Azimilide or Class 1 Antiarrhythmic agents in either arm of the trial.
- Quality of Life Score [At 6 months follow-up]
Quality of life score in each treatment arm using the EQ-5D Visual Analogue Scale (VAS) (euroqol.org). The EQ-5D VAS is a patient reported scale from 0 to 100 on which the patient rates how good or bad their health is today with 100 being the best health they can imagine and 0 being the worst health they can imagine.
Eligibility Criteria
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
-
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 - 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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 2 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 3 | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 4 | Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | United States | 78705 |
| 5 | University of Virginia Health System | Charlottesville | Virginia | United States | 22908 |
| 6 | Hamilton Health Sciences | Hamilton | Ontario | Canada | L8L 2X2 |
| 7 | Southlake Regional Health Centre | Newmarket | Ontario | Canada | L3Y 2P9 |
| 8 | University of Ottawa Heart Institute | Ottawa | Ontario | Canada | K1Y 4W7 |
| 9 | McGill University Health Center | Montreal | Quebec | Canada | H3G 1A4 |
| 10 | Institut Universitaire de Cardiologie et Pneumologie de Québec | Quebec | Canada | G1V 4G5 | |
| 11 | Beijng Fuwai Heart Hospital | Beijing | China | 100037 |
Sponsors and Collaborators
- Population Health Research Institute
- Abbott Medical Devices
- 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CEASE-VT
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Ablation | Amiodarone |
|---|---|---|
| Arm/Group Description | 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 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 |
| Period Title: Overall Study | ||
| STARTED | 7 | 5 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 7 | 5 |
Baseline Characteristics
| Arm/Group Title | Ablation | Amiodarone | Total |
|---|---|---|---|
| Arm/Group Description | 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 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 | Total of all reporting groups |
| Overall Participants | 7 | 5 | 12 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
63
(9.7)
|
57
(13.4)
|
61
(11.3)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
1
14.3%
|
0
0%
|
1
8.3%
|
| Male |
6
85.7%
|
5
100%
|
11
91.7%
|
| Region of Enrollment (participants) [Number] | |||
| Canada |
5
71.4%
|
3
60%
|
8
66.7%
|
| United States |
1
14.3%
|
0
0%
|
1
8.3%
|
| China |
1
14.3%
|
2
40%
|
3
25%
|
Outcome Measures
| Title | Number of Participants With Appropriate ICD Therapy, Slow VT or Sudden Cardiac Death |
|---|---|
| Description | Number of participants with a composite outcome of any of: Appropriate Implantable Cardioverter Defibrillator (ICD) therapy [Including antitachycardia pacing (ATP) and shocks] Slow ventricular tachycardia (VT) below ICD detection threshold leading to hospitalization or necessitates antiarrhythmic medications and/or catheter ablation Sudden Cardiac Death |
| Time Frame | From 30 days following randomization until final follow-up visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ablation | Amiodarone |
|---|---|---|
| Arm/Group Description | 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 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 |
| Measure Participants | 7 | 5 |
| Number [participants] |
1
14.3%
|
2
40%
|
| Title | Number of Participants With (a) Ablation or Amiodarone Complications, (b) Inappropriate Shocks From ICD, or (c) Need for Concomitant Use of Sotalol, Dofetilide, Azimilide or Class 1 Antiarrhythmic Agents in Either Arm of the Trial. |
|---|---|
| Description | Number of Participants with (a) Ablation or Amiodarone Complications, (b) Inappropriate Shocks from ICD, or (c) Need for Concomitant use of Sotalol, Dofetilide, Azimilide or Class 1 Antiarrhythmic agents in either arm of the trial. |
| Time Frame | from randomization until final follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ablation | Amiodarone |
|---|---|---|
| Arm/Group Description | 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 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 |
| Measure Participants | 7 | 5 |
| Number [participants] |
2
28.6%
|
0
0%
|
| Title | Quality of Life Score |
|---|---|
| Description | Quality of life score in each treatment arm using the EQ-5D Visual Analogue Scale (VAS) (euroqol.org). The EQ-5D VAS is a patient reported scale from 0 to 100 on which the patient rates how good or bad their health is today with 100 being the best health they can imagine and 0 being the worst health they can imagine. |
| Time Frame | At 6 months follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with data collected at 6 months |
| Arm/Group Title | Ablation | Amiodarone |
|---|---|---|
| Arm/Group Description | 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 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 |
| Measure Participants | 3 | 3 |
| Mean (Full Range) [score on a scale] |
59
|
83
|
Adverse Events
| Time Frame | Follow-up period from date of randomization until final follow-up visit. Events were assessed at 1 month, 6 months and 12 months after randomization. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Note that the study was terminated early for non-feasibility. 12 participants were enrolled, 9 completed 1 month of follow-up, 6 completed 6 months of follow-up and 1 completed 12 months of follow-up. | |||
| Arm/Group Title | Ablation | Amiodarone | ||
| Arm/Group Description | 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 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 | ||
All Cause Mortality |
||||
| Ablation | Amiodarone | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Ablation | Amiodarone | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/7 (28.6%) | 1/5 (20%) | ||
| Infections and infestations | ||||
| pneumonia | 0/7 (0%) | 0 | 1/5 (20%) | 1 |
| Renal and urinary disorders | ||||
| acute renal failure | 0/7 (0%) | 1/5 (20%) | ||
| Vascular disorders | ||||
| pseudo aneurysm | 2/7 (28.6%) | 0/5 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Ablation | Amiodarone | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/7 (0%) | 0/5 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Carlos Morillo |
|---|---|
| Organization | Population Health Research Institute |
| Phone | 905-527-4322 ext 40311 |
| Carlos.Morillo@phri.ca |
- CEASE-VT