Status:
COMPLETED
EASYTRAK 3 Downsize Lead
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the EASYTRAK 3 Downsize Lead.
Detailed Description
This is a prospective, non-randomized, multi-center US clinical investigation, designed to demonstrate the safety and effectiveness of the Guidant EASYTRAK 3 Downsize Lead in humans.
Eligibility Criteria
Inclusion
- Must be indicated for a Guidant CRT-P or CRT-D device
- Creatinine \< 2.5 mg/dL obtained no more than two weeks prior to enrollment
- Age 18 or above, or of legal age to give informed consent specific to state and national law
- Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigation center and at the intervals defined by this protocol
- Geographically stable residents who are available for follow-up
Exclusion
- Have a known hypersensitivity to a 0.5 mg nominal dose of dexamethasone acetate
- Have or had previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted LV lead placement
- Have pre-existing cardioversion/defibrillation leads or right ventricular pacing leads other than those specified in the investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads)
- Currently requiring dialysis
- Have had a myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment
- Have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis)
- Documented life expectancy of less than six months or expected to undergo heart transplant within the next six months
- Enrolled or participating in any concurrent study, including drug investigations, without Guidant written approval, that may confound the results of this study
- Have a pre-existing unipolar pacemaker that will not be explanted/abandoned
- Have a mechanical tricuspid heart valve
- Women who are pregnant or plan to become pregnant. Note: Women of childbearing potential must have a negative pregnancy test within seven days of enrollment.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00384722
Start Date
March 1 2006
End Date
May 1 2008
Last Update
June 24 2009
Active Locations (1)
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1
Multiple Locations
Saint Paul, Minnesota, United States, 55112