Study Results
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View full resultsBasic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2004-09-30
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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EASYTRAK EPI Lead
Subjects in this arm will be implanted or attempted with the EASYTRAK EPI lead.
EASYTRAK EPI lead
EASYTRAK EPI lead
Interventions
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EASYTRAK EPI lead
EASYTRAK EPI lead
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Beckman, MD
Role: PRINCIPAL_INVESTIGATOR
The Methodist Hospital Research Institute
Locations
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Multiple Locations in the US
Saint Paul, Minnesota, United States
Countries
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Other Identifiers
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Clinicals0001
Identifier Type: -
Identifier Source: org_study_id
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