The EASYTRAK EPI Clinical Investigation (EASYTRAK EPI)
Bradycardia, Congestive Heart Failure
About this trial
This is an interventional treatment trial for Bradycardia focused on measuring Artificial Cardiac Pacing, Implanted Electrodes
Eligibility Criteria
Inclusion Criteria: Patients who meet the EASYTRAK EPI indications Patients who are age 18 or above, or of legal age to give informed consent specific to state and national law Patients who are willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational center and at the intervals defined by this protocol Patients who meet any one of the following three conditions: Meet current indications for cardiac resynchronization therapy (CRT) and epicardial placement of a pace/sense lead on the left ventricle is preferred over an endocardial lead Meet current indications for a cardiac pacing system and have documented evidence that an endocardial lead cannot be used Meet current indications for a cardiac pacing system and a concurrent cardiac surgical procedure is taking place where no additional surgical procedures are required to provide access to the epicardial surface of the heart Exclusion Criteria: Patients who meet the EASYTRAK EPI contraindications Patients who have had a myocardial infarct, unstable angina, or percutaneous coronary intervention during the preceding 30 days prior to enrollment Patients with a documented life expectancy of less than 6 months or expected to undergo heart transplant within the next 6 months Patients enrolled in any concurrent study, without Guidant written approval, that may confound the results of this study Women who are pregnant or plan to become pregnant
Sites / Locations
- Multiple Locations in the US
Arms of the Study
Arm 1
Experimental
EASYTRAK EPI Lead
Subjects in this arm will be implanted or attempted with the EASYTRAK EPI lead.