ClinicalTrials.Veeva

Menu

The EASYTRAK EPI Clinical Investigation

Boston Scientific logo

Boston Scientific

Status

Completed

Conditions

Bradycardia
Congestive Heart Failure

Treatments

Device: EASYTRAK EPI lead

Study type

Interventional

Funder types

Industry

Identifiers

NCT00158925
Clinicals0001

Details and patient eligibility

About

The purpose of this study is to assess the safety and effectiveness of the EASYTRAK EPI lead.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

EASYTRAK EPI Lead
Experimental group
Description:
Subjects in this arm will be implanted or attempted with the EASYTRAK EPI lead.
Treatment:
Device: EASYTRAK EPI lead

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems