INTERVENE: Indian Trial of Endocardial Ventricular Substrate Ablation to Prevent Recurrent VT Events

• Status: Terminated
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study to is being conducted in India to determine the role of catheter-based ablation for ventricular tachycardia (VT) in post- heart attack patients who meet established guidelines for implantable cardiodefibrillator (ICD) implantation, but cannot afford it. These patients would be started on chronic Amiodarone therapy, which has been shown to be effective but can often lead to multiple side effects.

Patients will therefore be randomized in an even proportion to either a) the control group, receiving chronic Amiodarone therapy, or the study group, undergoing catheter ablation of VT in addition to chronic Amiodarone therapy.

This trial will serve as a representative model for the developing world.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborator: Biosense Webster, Inc.
• Treatments: Amiodarone

Criteria

Inclusion Criteria:

• ≥ 18 and ≤ 85 years of age

• History of a remote MI (≥1 month)

• Survival of a ventricular arrhythmic event (VT/VF) that would mandate placement of an implantable cardioverter-defibrillator (ICD) (Patients who experience a ventricular arrhythmic event (VT/VF) while already being treated with Amiodarone (100-200 mg/day) are not excluded from the study. This is permitted provided that the patient had been treated with Amiodarone for at least 2 months prior to experiencing the index VT/VF event. These patients are randomized to either a higher dose of Amiodarone (e.g., 100mg/day -> 200mg/day or 200mg/day -> 400mg/day) or a higher dose of Amiodarone plus catheter ablation.)

• Patient cannot afford an ICD and thus has been planned for treatment with Amiodarone (or an increased dose of Amiodarone)

• Ability to understand the requirements of the study

• Willingness to adhere to study restrictions and comply with all post- procedural follow-up requirements

Exclusion Criteria:

• 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 expectance <1 year for any medical condition