Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia: A Multi-center Randomized Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Enrollment
- 12
- Locations
- 11
- Primary Endpoint
- Number of Participants With Appropriate ICD Therapy, Slow VT or Sudden Cardiac Death
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 84 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Ablation
Catheter based radiofrequency ablation for ischemic ventricular tachycardia
Intervention: Ablation (Procedure)
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.
Intervention: Amiodarone (Drug)
Outcomes
Primary Outcomes
Number of Participants With Appropriate ICD Therapy, Slow VT or Sudden Cardiac Death
Time Frame: 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 Outcomes
- 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)
- Quality of Life Score(At 6 months follow-up)