Clinical Trial: EASYTRAK 3

This study has been completed.

Sponsored by: Guidant Corporation
Information provided by: Guidant Corporation
ClinicalTrials.gov Identifier: NCT00158938

Purpose

The purpose of this clinical investigation was to assess the safety and effectiveness of the EASYTRAK 3 lead
Condition Intervention Phase
Congestive Heart Failure
 Device: EASYTRAK 3 left ventricular pacing lead
Phase II
Phase III

MedlinePlus related topics:  Heart Failure

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further Study Details: 
Primary Outcomes: Pacing thresholds at 6 months; Pacing impedances at 6 months; R-wave amplitudes at 6 months; 6-month complication free rate
Secondary Outcomes: left ventricular bipolar pacing and sensing with RENEWAL 3 H173 safety
Expected Total Enrollment:  115

Study start: May 2003;  Study completion: December 2004
Last follow-up: March 2004;  Data entry closure: August 2004

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

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

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.

More Information

Study ID Numbers:  Clinicals0007
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00158938
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13

Resources

  • Lead (Centers for Disease Control and Prevention)
  • Lead (Lab Tests Online)



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