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The EASYTRAK EPI Clinical Investigation

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00158925
First received: September 8, 2005
Last updated: May 19, 2008
Last verified: May 2008
History of Changes
  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 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: The EASYTRAK EPI Clinical Investigation

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Chronic pacing thresholds at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Chronic pacing impedances at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Chronic sensing amplitudes at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Lead-related complication-free rate at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Lead implant time [ Time Frame: Implant ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: September 2004
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: EASYTRAK EPI lead
    EASYTRAK EPI lead
Detailed Description:

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 older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00158925

Locations
United States, Minnesota
Multiple Locations in the US
St. Paul, Minnesota, United States
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Daniel Beckman, MD The Methodist Hospital System
  More Information

No publications provided

Responsible Party: Steven McQuillan, Director of Clinical Affairs, Boston Scientific
ClinicalTrials.gov Identifier: NCT00158925     History of Changes
Other Study ID Numbers: Clinicals0001, EASYTRAK EPI
Study First Received: September 8, 2005
Last Updated: May 19, 2008
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Heart Failure
Bradycardia
Heart Diseases
 Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013