Status:
COMPLETED
The EASYTRAK EPI Clinical Investigation
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Bradycardia
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to assess the safety and effectiveness of the EASYTRAK EPI lead.
Detailed Description
This is a prospective, single-armed, multi-center U.S., Australian, Canadian, and European clinical investigation, designed to demonstrate the safety and effectiveness of the EASYTRAK EPI lead in huma...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00158925
Start Date
September 1 2004
End Date
February 1 2008
Last Update
May 31 2017
Active Locations (1)
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1
Multiple Locations in the US
Saint Paul, Minnesota, United States, 55112