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

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ClinicalTrials.gov Identifier: NCT00158938
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : June 25, 2007
Sponsor:
Information provided by:
Boston Scientific Corporation

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

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Device: EASYTRAK 3 left ventricular pacing lead Phase 2 Phase 3

Detailed Description:
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

Study Type : Interventional  (Clinical Trial)
Enrollment : 115 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead
Study Start Date : May 2003
Actual Study Completion Date : November 2004



Primary Outcome Measures :
  1. Pacing thresholds at 6 months
  2. Pacing impedances at 6 months
  3. R-wave amplitudes at 6 months
  4. 6-month complication free rate

Secondary Outcome Measures :
  1. left ventricular bipolar pacing and sensing with RENEWAL 3 H173 safety


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

ClinicalTrials.gov Identifier: NCT00158938     History of Changes
Other Study ID Numbers: Clinicals0007
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: June 25, 2007
Last Verified: June 2007

Keywords provided by Boston Scientific Corporation:
Artificial Cardiac Pacemaker
Implanted Electrodes

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases