search
Back to results

EASYTRAK 3 Downsize Lead

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EASYTRAK 3 Downsize 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 be indicated for a 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 0.5 mg 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 one-month
Chronic mean pacing thresholds at one-month.

Secondary Outcome Measures

Chronic mean R-wave amplitudes at one-month
Chronic mean pacing impedances at one-month.

Full Information

First Posted
October 3, 2006
Last Updated
June 23, 2009
Sponsor
Boston Scientific Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT00384722
Brief Title
EASYTRAK 3 Downsize Lead
Official Title
EASYTRAK® 3 Downsize Lead Clinical Investigation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
May 2008 (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 3 Downsize Lead.
Detailed Description
This is a prospective, non-randomized, multi-center US clinical investigation, designed to demonstrate the safety and effectiveness of the Guidant EASYTRAK 3 Downsize Lead in humans.

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
70 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
EASYTRAK 3 Downsize Lead
Intervention Description
EASYTRAK 3 Downsize Lead
Primary Outcome Measure Information:
Title
Lead-related complication-free rate at one-month
Time Frame
1 month
Title
Chronic mean pacing thresholds at one-month.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Chronic mean R-wave amplitudes at one-month
Time Frame
1 month
Title
Chronic mean pacing impedances at one-month.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must be indicated for a 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 0.5 mg 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
John Hummel, MD
Organizational Affiliation
Riverside Methodist Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Multiple Locations
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.nlm.nih.gov/medlineplus/
Description
Heart Failure

Learn more about this trial

EASYTRAK 3 Downsize Lead

We'll reach out to this number within 24 hrs