Cameron Health's S-ICD System: delivers a jolt through a sensor implanted under a patient's skin, but not wired to a patient's heart.
DEFIBRILLATOR COMPARED WITH MEDICATION IN STUDY 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. Trial no: NCT01097330