Defibrillators, Implantable, Tachycardia, Ventricular
Conditions
Keywords
Defibrillators, Implantable, Tachycardia, Ventricular, Catheter Ablation, Amiodarone
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.
Interventions
PROCEDUREAblation
Catheter based radiofrequency ablation for ischemic ventricular tachycardia scheduled to occur within 4 weeks after randomization
DRUGAmiodarone
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
Sponsors
Abbott Medical Devices
Hamilton Health Sciences Corporation
Population Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 84 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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: 1. Appropriate Implantable Cardioverter Defibrillator (ICD) therapy \[Including antitachycardia pacing (ATP) and shocks\] 2. Slow ventricular tachycardia (VT) below ICD detection threshold leading to hospitalization or necessitates antiarrhythmic medications and/or catheter ablation 3. Sudden Cardiac Death |
Secondary
| Measure | Time frame | 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. | 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. |
Countries
Canada, China, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 7 |
| 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 | 5 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study terminated early | 7 | 5 |
Baseline characteristics
| Characteristic | Ablation | Amiodarone | Total |
|---|---|---|---|
| Age, Continuous | 63 years STANDARD_DEVIATION 9.7 | 57 years STANDARD_DEVIATION 13.4 | 61 years STANDARD_DEVIATION 11.3 |
| Region of Enrollment Canada | 5 participants | 3 participants | 8 participants |
| Region of Enrollment China | 1 participants | 2 participants | 3 participants |
| Region of Enrollment United States | 1 participants | 0 participants | 1 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 0 / 5 |
| serious Total, serious adverse events | 2 / 7 | 1 / 5 |
Outcome results
Primary
Number of Participants With Appropriate ICD Therapy, Slow VT or Sudden Cardiac Death
Number of participants with a composite outcome of any of: 1. Appropriate Implantable Cardioverter Defibrillator (ICD) therapy \[Including antitachycardia pacing (ATP) and shocks\] 2. Slow ventricular tachycardia (VT) below ICD detection threshold leading to hospitalization or necessitates antiarrhythmic medications and/or catheter ablation 3. Sudden Cardiac Death
Time frame: From 30 days following randomization until final follow-up visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ablation | Number of Participants With Appropriate ICD Therapy, Slow VT or Sudden Cardiac Death | 1 participants |
| Amiodarone | Number of Participants With Appropriate ICD Therapy, Slow VT or Sudden Cardiac Death | 2 participants |
Secondary
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.
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ablation | 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. | 2 participants |
| Amiodarone | 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. | 0 participants |
Secondary
Quality of Life Score
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
Population: Participants with data collected at 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ablation | Quality of Life Score | 59 score on a scale |
| Amiodarone | Quality of Life Score | 83 score on a scale |