Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead (NCT00158938) | Clinical Trial Compass
CompletedPhase 2/3
Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead
115 participantsStarted 2003-05
Plain-language summary
The purpose of this clinical investigation was to assess the safety and effectiveness of the EASYTRAK 3 lead
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 …