To determine the role of catheter based VT ablation in the prevention of recurrent VT in post-MI patients who survive a life-threatening VT/VF event but cannot afford an implantable defibrillator. Patients will be randomized to either Amiodarone or Amiodarone plus catheter ablation.
- Conditions
- Health Condition 1: null- Ventricular Tachycardia
- Registration Number
- CTRI/2012/07/002827
- Lead Sponsor
- CARE Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 132
more than 18 and less than 85 years of age
History of a remote MI of more than 1 month
Survival of a ventricular arrhythmic event VT or VF that would mandate placement of an implantable cardioverter-defibrillator
Patient cannot afford an ICD and thus has been planned for treatment with Amiodarone
Ability to understand the requirements of the study
Willingness to adhere to study restrictions and comply with all postprocedural follow-up requirements
Patients with NYHA class IV congestive heart failure
Prior ablation for a ventricular arrhythmia
Presence of an LV thrombus
Contraindication to anticoagulation
Inability to access the endocardium because of mechanical mitral and aortic valve
Life expectancy of less than 1 year for any medical condition
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All-cause mortality and Cardiac Arrest and Sustained VTTimepoint: 24 months
- Secondary Outcome Measures
Name Time Method Proportion of subjects that die within 30 days or by the end of the study <br/ ><br>Total number of ventricular arrhythmic events, compared between the 2 treatment arms. <br/ ><br>Differences in LV ejection fraction between paired measurements recorded at baseline and 3 months for each patient will be used to test for significant differences between the two treatment arms. <br/ ><br>Quality of life. <br/ ><br>Timepoint: 30days <br/ ><br>24months <br/ ><br>3 months