At a glance
ClinicalIndex Comparison RecordN/ACompleted· 100 enrolled
Drug / intervention
EASYTRAK EPI leaddevice
Likely dose
Not stated in record
Key inclusion· 5
- ✓Meet indications for cardiac resynchronization therapy (CRT) with preference for epicardial left ventricular lead over endocardial approach
- ✓Meet indications for cardiac pacing system with documented evidence that endocardial lead cannot be used
- ✓Meet indications for cardiac pacing system with concurrent cardiac surgical procedure where no additional procedures needed for epicardial access
- ✓Age 18 or above, or of legal age per state and national law
Key exclusion· 5
- ✕Myocardial infarction, unstable angina, or percutaneous coronary intervention within 30 days prior to enrollment
- ✕Documented life expectancy less than 6 months
- ✕Expected to undergo heart transplant within the next 6 months
- ✕Enrollment in any concurrent study without written Guidant approval that may confound results
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The EASYTRAK EPI Clinical Investigation
In Brief
A clinical study evaluating EASYTRAK EPI lead for Bradycardia and Congestive Heart Failure. Completed, enrolled 100 participants across 1 site.
Detailed Summary
The purpose of this study is to assess the safety and effectiveness of the EASYTRAK EPI lead.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBradycardia, Congestive Heart Failure
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2004
First PostedSep 2005
Primary CompletionFeb 2008
TodayJul 2026
First PostedSep 12, 2005
Enrollment StartSep 1, 2004
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 20.8 years ago
Interventions
EASYTRAK EPI leaddevice
EASYTRAK EPI lead