Safety and Efficacy Study of the QuickFlex Micro Model 1258T Left Heart Pacing Lead

QuickFlex Micro Model 1258T Left Heart Pacing Lead

This is a prospective, multi-center non-randomized clinical study to evaluate the safety and efficacy of the QuickFlex Micro Model 1258T left ventricular lead in a heart failure patient population. The study will be conducted at a maximum of 20 investigational centers located in the United States and a total of 68 patients will be enrolled.

The investigational left heart lead, QuickFlex Model 1258T, will be implanted with a legally marketed St. Jude Medical cardiac resynchronization therapy implantable cardioverter defibrillator (CRT-D) device.

Patients will be followed at Pre-Discharge, 1-Month, 3-Month,and then every 6 months until the end of the study.

Inclusion Criteria:

• Approved indication for CRT-D system

Exclusion Criteria:

• Previous cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months of enrollment
• Previous left ventricular (LV) lead implant
• Have had a heart attack,unstable angina or cardiac revascularization (percutaneous transluminal coronary angioplasty (PTCA),coronary artery bypass grafting (CABG), Stent) within 40 days prior to enrollment