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St.Paul, Minnesota

  • Heart Failure

Purpose:

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


Study summary:

This is a prospective, multi-center clinical study is to evaluate the safety and effectiveness of the EASYTRAK 4 STEERABLE LV lead.


Criteria:

Inclusion Criteria: - 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 Exclusion Criteria: - 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.


NCT ID:

NCT00158964


Primary Contact:

Principal Investigator
Stephen Mester, MD
Tampa General Hospital


Backup Contact:

N/A


Location Contact:

St.Paul, Minnesota
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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