The EASYTRAK EPI Clinical Investigation

Completed · Not applicable

Conditions studied: Bradycardia, Congestive Heart Failure

In brief

The purpose of this study is to assess the safety and effectiveness of the EASYTRAK EPI lead.

Key facts

Study ID

NCT00158925

Run by

Boston Scientific Corporation

People needed

100

Starts

2004-09-01

Expected to finish

2008-02-01

Last updated by the study team

2017-05-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Multiple Locations in the US — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.