Clinical Trial: EASYTRAK EPI

This study is currently recruiting patients.
Verified by Guidant Corporation September 2005

Sponsored by: Guidant Corporation
Information provided by: Guidant Corporation
ClinicalTrials.gov Identifier: NCT00158925

Purpose

The purpose of this study is to assess the safety and effectiveness of the EASYTRAK EPI lead.
Condition Intervention Phase
Bradycardia
Congestive Heart Failure
 Device: EASYTRAK EPI lead
Phase III

MedlinePlus related topics:  Arrhythmia;   Heart Failure

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

Official Title: The EASYTRAK EPI Clinical Investigation

Further Study Details: 
Primary Outcomes: Chronic Pacing Thresholds at 3 Months; Chronic Pacing Impedances at 3 Months; Chronic Sensing Amplitudes at 3 Months; Lead-Related Complication-Free Rate at 3 Months
Secondary Outcomes: Lead Implant Time
Expected Total Enrollment:  100

Study start: September 2004

This is a prospective, single-armed, multi-center U.S., Australian, Canadian, and European clinical investigation, designed to demonstrate the safety and effectiveness of the EASYTRAK EPI lead in humans.

Eligibility

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

Inclusion Criteria:

  • Patients who meet the EASYTRAK EPI indications
  • Patients who are age 18 or above, or of legal age to give informed consent specific to state and national law
  • Patients who are 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
  • Patients who meet any one of the following three conditions:

    • Meet current indications for Cardiac Resynchronization Therapy (CRT) and epicardial placement of a pace/sense lead on the left ventricle is preferred over an endocardial lead
    • Meet current indications for a cardiac pacing system and have documented evidence that an endocardial lead cannot be used
    • Meet current indications for a cardiac pacing system and a concurrent cardiac surgical procedure is taking place where no additional surgical procedures are required to provide access to the epicardial surface of the heart

Exclusion Criteria:

  • Patients who meet the EASYTRAK EPI contraindications
  • Patients who have had a myocardial infarct, unstable angina, or percutaneous coronary intervention during the preceding 30 days prior to enrollment
  • Patients with a documented life expectancy of less than 6 months or expected to undergo heart transplant within the next 6 months
  • Patients enrolled in any concurrent study, without Guidant written approval, that may confound the results of this study
  • Women who are pregnant or plan to become pregnant

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00158925

Clinical Studies Help Desk      1-800-CARDIAC  Ext. 24432    zzzcshdl@guidant.com

Minnesota
      Multiple Locations in the US, St. Paul,  Minnesota,  United States; Recruiting

Study chairs or principal investigators

Daniel Beckman, MD,  Principal Investigator,  Methodist Hospital   

More Information

Study ID Numbers:  Clinicals0001
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00158925
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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