Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia

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.

Conditions

• Defibrillators, Implantable
• Tachycardia, Ventricular

Interventions

PROCEDURE

Ablation

Catheter based radiofrequency ablation for ischemic ventricular tachycardia scheduled to occur within 4 weeks after randomization

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

Sponsors & Collaborators

• Abbott Medical Devices

  collaborator INDUSTRY

• Hamilton Health Sciences Corporation

  collaborator OTHER

• Population Health Research Institute

  lead OTHER

Principal Investigators

• Andrea Natale, M.D. · Texas Cardiac Arrhythmia Research Foundation

• David J Callans, M.D. · University of Pennsylvania

• Carlos A. Morillo, M.D. · Population Health Research Institute, McMaster University

• Girish M. Nair, M.D. · Population Health Research Institute, McMaster University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

84 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-08-31

Primary Completion

2012-03-31

Completion

2012-03-31

Countries

• United States
• Canada
• China

Study Locations