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The EASYTRAK EPI Clinical Investigation (EASYTRAK EPI)

Primary Purpose

Bradycardia, Congestive Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EASYTRAK EPI lead
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bradycardia focused on measuring Artificial Cardiac Pacing, Implanted Electrodes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Multiple Locations in the US

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EASYTRAK EPI Lead

Arm Description

Subjects in this arm will be implanted or attempted with the EASYTRAK EPI lead.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
September 8, 2005
Last Updated
May 2, 2017
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00158925
Brief Title
The EASYTRAK EPI Clinical Investigation
Acronym
EASYTRAK EPI
Official Title
The EASYTRAK EPI Clinical Investigation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia, Congestive Heart Failure
Keywords
Artificial Cardiac Pacing, Implanted Electrodes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EASYTRAK EPI Lead
Arm Type
Experimental
Arm Description
Subjects in this arm will be implanted or attempted with the EASYTRAK EPI lead.
Intervention Type
Device
Intervention Name(s)
EASYTRAK EPI lead
Intervention Description
EASYTRAK EPI lead
Primary Outcome Measure Information:
Title
Chronic Pacing Thresholds at 3 Months
Description
The expected mean pacing threshold is 1.9V at 0.5 ms pulse width.
Time Frame
3 months
Title
Chronic Pacing Impedances at 3 Months
Description
The expected mean impedance is 500 Ohms.
Time Frame
3 months
Title
Chronic Sensing Amplitudes at 3 Months
Description
The expected mean is 10mV.
Time Frame
3 months
Title
Lead-related Complication-free Rate at 3 Months
Description
The estimated target value for this endpoint is 80%.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Lead Implant Time
Description
The estimated target value for average implant time is 30 minutes. Unit of measure will be the time period needed for the implant.
Time Frame
Implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Beckman, MD
Organizational Affiliation
The Methodist Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Multiple Locations in the US
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The EASYTRAK EPI Clinical Investigation

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