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
  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:


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 April 17, 2014