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

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Pacing thresholds at 6 months
  • Pacing impedances at 6 months
  • R-wave amplitudes at 6 months
  • 6-month complication free rate

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

Estimated Enrollment: 115
Study Start Date: May 2003
Study Completion Date: November 2004
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  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.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00158938     History of Changes
Other Study ID Numbers: Clinicals0007
Study First Received: September 8, 2005
Last Updated: June 22, 2007
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014