The EASYTRAK EPI Clinical Investigation

Study Overview
=================
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.

Official Title
-----------------
The EASYTRAK EPI Clinical Investigation

Conditions
-----------------
Bradycardia, Congestive Heart Failure

Intervention / Treatment
-----------------
* Device: EASYTRAK EPI lead


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EASYTRAK EPI Lead<br>Subjects in this arm will be implanted or attempted with the EASYTRAK EPI lead. | Device: EASYTRAK EPI lead<br>* EASYTRAK EPI lead<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lead Implant Time | The estimated target value for average implant time is 30 minutes. Unit of measure will be the time period needed for the implant. | Implant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Artificial Cardiac Pacing, Implanted Electrodes