Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
110 participants
INTERVENTIONAL
2005-03-31
2007-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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EASYTRAK 4 STEERABLE LV lead
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Principal Investigators
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Stephen Mester, MD
Role: PRINCIPAL_INVESTIGATOR
Tampa General Hospital
Locations
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Multiple locations
Saint Paul, Minnesota, United States
Countries
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Other Identifiers
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Clinicals0006
Identifier Type: -
Identifier Source: org_study_id