The EASYTRAK EPI Clinical Investigation

Not Applicable

Completed

• Conditions: Bradycardia; Congestive Heart Failure
• Interventions: Device: EASYTRAK EPI lead

• Registration Number: NCT00158925
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Results First Submitted: 2017-03-17
• Results First Submitted QC: 2017-03-17
• Results First Posted: 2017-04-28
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EASYTRAK EPI Lead	EASYTRAK EPI lead	Subjects in this arm will be implanted or attempted with the EASYTRAK EPI lead.

Primary Outcome Measures

Name	Time	Method
Lead-related Complication-free Rate at 3 Months	3 months	The estimated target value for this endpoint is 80%.
Chronic Sensing Amplitudes at 3 Months	3 months	The expected mean is 10mV.
Chronic Pacing Thresholds at 3 Months	3 months	The expected mean pacing threshold is 1.9V at 0.5 ms pulse width.
Chronic Pacing Impedances at 3 Months	3 months	The expected mean impedance is 500 Ohms.

Secondary Outcome Measures

Name	Time	Method
Lead Implant Time	Implant	The estimated target value for average implant time is 30 minutes. Unit of measure will be the time period needed for the implant.

Trial Locations

Locations (1)

Multiple Locations in the US; 🇺🇸 Saint Paul, Minnesota, United States