EASYTRAK 4 Steerable LV Lead

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00158964
First received: September 8, 2005
Last updated: June 22, 2007
Last verified: June 2007

September 8, 2005
June 22, 2007
March 2005
Not Provided
  • Lead-related complication free-rate at 3-months.
  • Chronic mean pacing thresholds at 3-months.
Same as current
Complete list of historical versions of study NCT00158964 on ClinicalTrials.gov Archive Site
  • Chronic Mean pacing impedances at 3-months
  • Chronic Mean R-wave amplitudes at 3-months
Same as current
Not Provided
Not Provided
 
EASYTRAK 4 Steerable LV Lead
EASYTRAK® 4 STEERABLE LV Lead Clinical Investigation

The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the EASYTRAK 4 STEERABLE LV lead.

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

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Failure
Device: EASYTRAK 4 STEERABLE LV lead
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
April 2007
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00158964
Clinicals0006
Not Provided
Not Provided
Boston Scientific Corporation
Not Provided
Principal Investigator: Stephen Mester, MD Tampa General Hospital
Boston Scientific Corporation
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP