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EASYTRAK 3 Downsize Lead

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ClinicalTrials.gov Identifier: NCT00384722
Recruitment Status : Completed
First Posted : October 6, 2006
Last Update Posted : June 24, 2009
Information provided by:
Boston Scientific Corporation

Brief Summary:
The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the EASYTRAK 3 Downsize Lead.

Condition or disease Intervention/treatment Phase
Heart Failure Device: EASYTRAK 3 Downsize Lead Phase 2 Phase 3

Detailed Description:
This is a prospective, non-randomized, multi-center US clinical investigation, designed to demonstrate the safety and effectiveness of the Guidant EASYTRAK 3 Downsize Lead in humans.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EASYTRAK® 3 Downsize Lead Clinical Investigation
Study Start Date : March 2006
Primary Completion Date : July 2006
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Intervention Details:
    Device: EASYTRAK 3 Downsize Lead
    EASYTRAK 3 Downsize Lead

Primary Outcome Measures :
  1. Lead-related complication-free rate at one-month [ Time Frame: 1 month ]
  2. Chronic mean pacing thresholds at one-month. [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Chronic mean R-wave amplitudes at one-month [ Time Frame: 1 month ]
  2. Chronic mean pacing impedances at one-month. [ Time Frame: 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must be indicated for a 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 0.5 mg 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384722

United States, Minnesota
Multiple Locations
St. Paul, Minnesota, United States, 55112
Sponsors and Collaborators
Boston Scientific Corporation
Principal Investigator: John Hummel, MD Riverside Methodist Hospital

Additional Information:
Responsible Party: Steven McQuillan, Director of Clinical Affairs, Boston Scientific
ClinicalTrials.gov Identifier: NCT00384722     History of Changes
Other Study ID Numbers: Clinicals0011
First Posted: October 6, 2006    Key Record Dates
Last Update Posted: June 24, 2009
Last Verified: June 2009

Keywords provided by Boston Scientific Corporation:
Left ventricular lead
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases