The EASYTRAK EPI Clinical Investigation

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)

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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