Clinical Trial: EASYTRAK 4 Steerable

This study is no longer recruiting patients.

Sponsored by: Guidant Corporation
Information provided by: Guidant Corporation
ClinicalTrials.gov Identifier: NCT00158964

Purpose

The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the EASYTRAK 4 STEERABLE LV lead.
Condition Intervention Phase
Heart Failure
 Device: EASYTRAK 4 STEERABLE LV lead
Phase II
Phase III

MedlinePlus related topics:  Cardiomyopathy

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title: EASYTRAK® 4 STEERABLE LV Lead Clinical Investigation

Further Study Details: 
Primary Outcomes: Lead-related complication free-rate at 3-months.; Chronic mean pacing thresholds at 3-months.
Secondary Outcomes: Chronic Mean pacing impedances at 3-months; Chronic Mean R-wave amplitudes at 3-months
Expected Total Enrollment:  110

Study start: March 2005
Last follow-up: August 2005

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

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
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.

Location Information


Minnesota
      Multiple locations, St. Paul,  Minnesota,  United States

Study chairs or principal investigators

Stephen Mester, MD,  Principal Investigator,  Tampa General Hospital   

More Information

Study ID Numbers:  Clinicals0006
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00158964
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13

Resources

  • Lead (Centers for Disease Control and Prevention)
  • Lead (Lab Tests Online)



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