EASYTRAK 3 Downsize Lead

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00384722
First received: October 3, 2006
Last updated: June 23, 2009
Last verified: June 2009
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: EASYTRAK® 3 Downsize Lead Clinical Investigation

Resource links provided by NLM:


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
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

Additional Information:
No publications provided

Responsible Party: Steven McQuillan, Director of Clinical Affairs, Boston Scientific
ClinicalTrials.gov Identifier: NCT00384722     History of Changes
Other Study ID Numbers: Clinicals0011
Study First Received: October 3, 2006
Last Updated: June 23, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014