InSync III Marquis Model 7279 Cardioverter Defibrillator Cardiac Resynchronization System

Inclusion Criteria: Subject has, or is at risk of having, a heart beat that is too fast and his/her doctor has determined the need for an implantable cardioverter defibrillator. Subject is on optimal medical treatment for heart failure. Subject has reduced left ventricular ejection fraction (LVEF≤35%). (LVEF is a measurement of how well the left ventricle pumps blood out to the rest of the body. The higher the LVEF the more blood the ventricle is pumping.) Subject who has heart failure which severely limits daily activities (NYHA Class III) or subject who has severe heart failure and should always be resting (NYHA Class IV) Subject who has a QRS≥130ms (The QRS interval is a measurement of how the electrical signal involved in a heart beat travels/conducts through the ventricles. A wide QRS (more than 120 ms) suggests that there is a conduction problem (or block) in the ventricles.) Subjects with a left ventricular end diastolic dimension (LVEDD≥55mm). (The LVEDD is a measurement taken during an echocardiogram that is one indication of the health of the left ventricle.) Exclusion Criteria: Subject has unstable chest pain, heart surgery within past 3 months Subject has liver function tests greater than 3 times normal limits Subject has chronic (permanent) atrial arrhythmias (fast heart beats in the upper chamber(s) of the heart)