InSync III Marquis Model 7279 Cardioverter Defibrillator Cardiac Resynchronization System

Launched by MEDTRONIC CARDIAC RHYTHM AND HEART FAILURE · Dec 28, 2005

Keywords

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Gender

ALL

Eligibility criteria

• 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)