Status:
COMPLETED
Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this clinical investigation was to assess the safety and effectiveness of the EASYTRAK 3 lead
Detailed Description
This clinical study was a prospective, multi-center, clinical evaluation to document safety and effectiveness of the EASYTRAK 3 lead in humans. Patients implanted with the EASYTRAK 3 lead were followe...
Eligibility Criteria
Inclusion
- Moderate to severe heart failure (NYHA Class III/IV) including left ventricular dysfunction (EF \<= 35%) and QRS duration \>= 120 ms remaining symptomatic despite stable, optimal heart failure drug therapy.
- 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 investigational center and at the intervals defined by this protocol.
Exclusion
- A known hypersensitivity to a 1.0 mg (0.5 mg per electrode) dose of dexamethasone acetate.
- Previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted LV lead placement.
- Pre-existing cardioversion/defibrillation leads other than those specified in this investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads).
- Requiring dialysis.
- A myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment.
- Hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis).
- A documented life expectancy of less than 6 months or expected to undergo heart transplant within 6 months.
- Enrolled in any concurrent study, without prior Guidant written approval, that may confound the results of this study.
- Have a mechanical tricuspid heart valve.
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2004
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00158938
Start Date
May 1 2003
End Date
November 1 2004
Last Update
June 25 2007
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