The EASYTRAK EPI Clinical Investigation

Congestive Heart Failure Clinical Trial

Official title:

The EASYTRAK EPI Clinical Investigation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00158925
• Other study ID #: Clinicals0001
• Secondary ID: EASYTRAK EPI
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: May 19, 2008
• Start date: September 2004
• Est. completion date: February 2008

Study information

• Verified date: May 2008
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bradycardia
• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• EASYTRAK EPI lead
EASYTRAK EPI lead

Locations

Country	Name	City	State
United States	Multiple Locations in the US	St. Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic pacing thresholds at 3 months		3 months	Yes
Primary	Chronic pacing impedances at 3 months		3 months	Yes
Primary	Chronic sensing amplitudes at 3 months		3 months	Yes
Primary	Lead-related complication-free rate at 3 months		3 months	Yes
Secondary	Lead implant time		Implant	No