EASYTRAK 3 Downsize Lead

EASYTRAK® 3 Downsize Lead Clinical Investigation

The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the EASYTRAK 3 Downsize Lead.

This is a prospective, non-randomized, multi-center US clinical investigation, designed to demonstrate the safety and effectiveness of the Guidant EASYTRAK 3 Downsize Lead in humans.

Inclusion Criteria:

• Must be indicated for a Guidant CRT-P or CRT-D device
• Creatinine < 2.5 mg/dL obtained no more than two weeks prior to enrollment
• Age 18 or above, or of legal age to give informed consent specific to state and national law
• Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigation center and at the intervals defined by this protocol
• Geographically stable residents who are available for follow-up

Exclusion Criteria:

• Have a known hypersensitivity to a 0.5 mg nominal dose of dexamethasone acetate
• Have or had previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted LV lead placement
• Have pre-existing cardioversion/defibrillation leads or right ventricular pacing leads other than those specified in the investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads)
• Currently requiring dialysis
• Have had a myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment
• Have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis)
• Documented life expectancy of less than six months or expected to undergo heart transplant within the next six months
• Enrolled or participating in any concurrent study, including drug investigations, without Guidant written approval, that may confound the results of this study
• Have a pre-existing unipolar pacemaker that will not be explanted/abandoned
• Have a mechanical tricuspid heart valve
• Women who are pregnant or plan to become pregnant. Note: Women of childbearing potential must have a negative pregnancy test within seven days of enrollment.