EASYTRAK 4 Steerable LV Lead

Completed · Phase 2/Phase 3

Conditions studied: Heart Failure

In brief

The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the EASYTRAK 4 STEERABLE LV lead.

Key facts

Study ID

NCT00158964

Run by

Boston Scientific Corporation

People needed

110

Starts

2005-03-01

Expected to finish

2007-04-01

Last updated by the study team

2007-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must receive a commercially available 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

You may not qualify if…

• Have a known hypersensitivity to a 1.0 mg (0.5 mg per electrode) 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.

Where it is running

• Multiple locations — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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