The EASYTRAK EPI Clinical Investigation (NCT00158925) | Clinical Trial Compass
CompletedNot Applicable
The EASYTRAK EPI Clinical Investigation
United States100 participantsStarted 2004-09
Plain-language summary
The purpose of this study is to assess the safety and effectiveness of the EASYTRAK EPI lead.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…