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EASYTRAK 3 Downsize Lead

This study is ongoing, but not recruiting participants.

Sponsored by: Boston Scientific Corporation
Information provided by: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00384722
  Purpose

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


Condition Intervention Phase
Heart Failure
Device: EASYTRAK 3 Downsize Lead
Phase II
Phase III

MedlinePlus related topics:   Heart Failure   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   EASYTRAK® 3 Downsize Lead Clinical Investigation

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Lead-related complication-free rate at one-month [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Chronic mean pacing thresholds at one-month. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Chronic mean R-wave amplitudes at one-month [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Chronic mean pacing impedances at one-month. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Enrollment:   70
Study Start Date:   March 2006
Estimated Study Completion Date:   May 2008
Primary Completion Date:   July 2006 (Final data collection date for primary outcome measure)

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

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384722

Locations
United States, Minnesota
Multiple Locations    
      St. Paul, Minnesota, United States, 55112

Sponsors and Collaborators
Boston Scientific Corporation

Investigators
Principal Investigator:     John Hummel, MD     Riverside Methodist Hospital    
  More Information


Heart Failure  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Boston Scientific ( Steven McQuillan, Director of Clinical Affairs )
Study ID Numbers:   Clinicals0011
First Received:   October 3, 2006
Last Updated:   December 19, 2007
ClinicalTrials.gov Identifier:   NCT00384722
Health Authority:   United States: Food and Drug Administration

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

Study placed in the following topic categories:
Heart Failure
Heart Diseases

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 29, 2008




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