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EASYTRAK 4 Steerable LV Lead

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EASYTRAK 4 STEERABLE LV lead
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring left ventricular lead, pacing, heart failure

Eligibility Criteria

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

Inclusion Criteria: Must receive a commercially available Guidant CRT-P or CRT-D device Creatinine < 2.5 mg/dL obtained no more than two weeks prior to enrollment Age 18 or above, or of legal age to give informed consent specific to state and national law Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigation center and at the intervals defined by this protocol Geographically stable residents who are available for follow-up Exclusion Criteria: Have a known hypersensitivity to a 1.0 mg (0.5 mg per electrode) nominal dose of dexamethasone acetate Have or had previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted LV lead placement Have pre-existing cardioversion/defibrillation leads or right ventricular pacing leads other than those specified in the investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads) Currently requiring dialysis Have had a myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment Have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis) Documented life expectancy of less than six months or expected to undergo heart transplant within the next six months Enrolled or participating in any concurrent study, including drug investigations, without Guidant written approval, that may confound the results of this study Have a pre-existing unipolar pacemaker that will not be explanted/abandoned Have a mechanical tricuspid heart valve Women who are pregnant or plan to become pregnant Note: Women of childbearing potential must have a negative pregnancy test within seven days of enrollment.

Sites / Locations

  • Multiple locations

Outcomes

Primary Outcome Measures

Lead-related complication free-rate at 3-months.
Chronic mean pacing thresholds at 3-months.

Secondary Outcome Measures

Chronic Mean pacing impedances at 3-months
Chronic Mean R-wave amplitudes at 3-months

Full Information

First Posted
September 8, 2005
Last Updated
June 22, 2007
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00158964
Brief Title
EASYTRAK 4 Steerable LV Lead
Official Title
EASYTRAK® 4 STEERABLE LV Lead Clinical Investigation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Boston Scientific Corporation

4. Oversight

5. Study Description

Brief Summary
The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the EASYTRAK 4 STEERABLE LV lead.
Detailed Description
This is a prospective, multi-center clinical study is to evaluate the safety and effectiveness of the EASYTRAK 4 STEERABLE LV lead.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
left ventricular lead, pacing, heart failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
110 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
EASYTRAK 4 STEERABLE LV lead
Primary Outcome Measure Information:
Title
Lead-related complication free-rate at 3-months.
Title
Chronic mean pacing thresholds at 3-months.
Secondary Outcome Measure Information:
Title
Chronic Mean pacing impedances at 3-months
Title
Chronic Mean R-wave amplitudes at 3-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must receive a commercially available Guidant CRT-P or CRT-D device Creatinine < 2.5 mg/dL obtained no more than two weeks prior to enrollment Age 18 or above, or of legal age to give informed consent specific to state and national law Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigation center and at the intervals defined by this protocol Geographically stable residents who are available for follow-up Exclusion Criteria: Have a known hypersensitivity to a 1.0 mg (0.5 mg per electrode) nominal dose of dexamethasone acetate Have or had previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted LV lead placement Have pre-existing cardioversion/defibrillation leads or right ventricular pacing leads other than those specified in the investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads) Currently requiring dialysis Have had a myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment Have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis) Documented life expectancy of less than six months or expected to undergo heart transplant within the next six months Enrolled or participating in any concurrent study, including drug investigations, without Guidant written approval, that may confound the results of this study Have a pre-existing unipolar pacemaker that will not be explanted/abandoned Have a mechanical tricuspid heart valve Women who are pregnant or plan to become pregnant Note: Women of childbearing potential must have a negative pregnancy test within seven days of enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Mester, MD
Organizational Affiliation
Tampa General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Multiple locations
City
St.Paul
State/Province
Minnesota
Country
United States

12. IPD Sharing Statement

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EASYTRAK 4 Steerable LV Lead

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