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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014