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The EASYTRAK EPI Clinical Investigation (EASYTRAK EPI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00158925
First received: September 8, 2005
Last updated: March 17, 2017
Last verified: March 2017
  Purpose
The purpose of this study is to assess the safety and effectiveness of the EASYTRAK EPI lead.

Condition Intervention
Bradycardia
Congestive Heart Failure
Device: EASYTRAK EPI lead

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: The EASYTRAK EPI Clinical Investigation

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Chronic Pacing Thresholds at 3 Months [ Time Frame: 3 months ]
    The expected mean pacing threshold is 1.9V at 0.5 ms pulse width.

  • Chronic Pacing Impedances at 3 Months [ Time Frame: 3 months ]
    The expected mean impedance is 500 Ohms.

  • Chronic Sensing Amplitudes at 3 Months [ Time Frame: 3 months ]
    The expected mean is 10mV.

  • Lead-related Complication-free Rate at 3 Months [ Time Frame: 3 months ]
    The estimated target value for this endpoint is 80%.


Secondary Outcome Measures:
  • Lead Implant Time [ Time Frame: Implant ]
    The estimated target value for average implant time is 30 minutes.


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)
Arms Assigned Interventions
Experimental: EASYTRAK EPI Lead
Subjects in this arm will be implanted with the EASYTRAK EPI lead.
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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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.

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, 55112
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Daniel Beckman, MD The Methodist Hospital System
  More Information

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00158925     History of Changes
Other Study ID Numbers: Clinicals0001
Study First Received: September 8, 2005
Results First Received: March 17, 2017
Last Updated: March 17, 2017
Individual Participant Data  
Plan to Share IPD: No

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 24, 2017