N/A
Completed N=96
The EASYTRAK EPI Clinical Investigation
Bradycardia · Heart Failure
Source: ClinicalTrials.gov NCT00158925 ↗
Enrolled (actual)
96
Serious AEs
57.3%
Results posted
Apr 2017
Primary outcomePrimary: Chronic Pacing Thresholds at 3 Months — 0.9 V
Summary
The purpose of this study is to assess the safety and effectiveness of the EASYTRAK EPI lead.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Chronic Pacing Thresholds at 3 Months |
0.9 | — |
| PRIMARY Chronic Pacing Impedances at 3 Months |
500 | — |
| PRIMARY Chronic Sensing Amplitudes at 3 Months |
15.8 | — |
| PRIMARY Lead-related Complication-free Rate at 3 Months |
97.9 | — |
| SECONDARY Lead Implant Time |
1.47 | — |
Eligibility Criteria
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 the results of this study
- Women who are pregnant or plan to become pregnant
Data sourced from ClinicalTrials.gov (NCT00158925). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.