Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00158938
First received: September 8, 2005
Last updated: June 22, 2007
Last verified: June 2007

September 8, 2005
June 22, 2007
May 2003
Not Provided
  • Pacing thresholds at 6 months
  • Pacing impedances at 6 months
  • R-wave amplitudes at 6 months
  • 6-month complication free rate
Same as current
Complete list of historical versions of study NCT00158938 on ClinicalTrials.gov Archive Site
left ventricular bipolar pacing and sensing with RENEWAL 3 H173 safety
Same as current
Not Provided
Not Provided
 
Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead
Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead

The purpose of this clinical investigation was to assess the safety and effectiveness of the EASYTRAK 3 lead

This clinical study was a prospective, multi-center, clinical evaluation to document safety and effectiveness of the EASYTRAK 3 lead in humans. Patients implanted with the EASYTRAK 3 lead were followed through pre-discharge, 1-month, 3-month and 6-month follow-ups

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Congestive Heart Failure
Device: EASYTRAK 3 left ventricular pacing 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
115
November 2004
Not Provided

Inclusion Criteria:

  • Moderate to severe heart failure (NYHA Class III/IV) including left ventricular dysfunction (EF <= 35%) and QRS duration >= 120 ms remaining symptomatic despite stable, optimal heart failure drug therapy.
  • 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 investigational center and at the intervals defined by this protocol.

Exclusion Criteria:

  • A known hypersensitivity to a 1.0 mg (0.5 mg per electrode) dose of dexamethasone acetate.
  • Previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted LV lead placement.
  • Pre-existing cardioversion/defibrillation leads other than those specified in this investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads).
  • Requiring dialysis.
  • A myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment.
  • Hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis).
  • A documented life expectancy of less than 6 months or expected to undergo heart transplant within 6 months.
  • Enrolled in any concurrent study, without prior Guidant written approval, that may confound the results of this study.
  • Have a mechanical tricuspid heart valve.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00158938
Clinicals0007
Not Provided
Not Provided
Boston Scientific Corporation
Not Provided
Not Provided
Boston Scientific Corporation
June 2007

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