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Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead

Primary Purpose

Congestive Heart Failure

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
EASYTRAK 3 left ventricular pacing lead
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring Artificial Cardiac Pacemaker, Implanted Electrodes

Eligibility Criteria

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

Inclusion Criteria: Moderate to severe heart failure (NYHA Class III/IV) including left ventricular dysfunction (EF <= 35%) and QRS duration >= 120 ms remaining symptomatic despite stable, optimal heart failure drug therapy. 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 investigational center and at the intervals defined by this protocol. Exclusion Criteria: A known hypersensitivity to a 1.0 mg (0.5 mg per electrode) dose of dexamethasone acetate. Previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted LV lead placement. Pre-existing cardioversion/defibrillation leads other than those specified in this investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads). Requiring dialysis. A myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment. Hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis). A documented life expectancy of less than 6 months or expected to undergo heart transplant within 6 months. Enrolled in any concurrent study, without prior Guidant written approval, that may confound the results of this study. Have a mechanical tricuspid heart valve.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Pacing thresholds at 6 months
    Pacing impedances at 6 months
    R-wave amplitudes at 6 months
    6-month complication free rate

    Secondary Outcome Measures

    left ventricular bipolar pacing and sensing with RENEWAL 3 H173 safety

    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
    NCT00158938
    Brief Title
    Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead
    Official Title
    Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    November 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Boston Scientific Corporation

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this clinical investigation was to assess the safety and effectiveness of the EASYTRAK 3 lead
    Detailed Description
    This clinical study was a prospective, multi-center, clinical evaluation to document safety and effectiveness of the EASYTRAK 3 lead in humans. Patients implanted with the EASYTRAK 3 lead were followed through pre-discharge, 1-month, 3-month and 6-month follow-ups

    6. Conditions and Keywords

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

    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
    115 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    EASYTRAK 3 left ventricular pacing lead
    Primary Outcome Measure Information:
    Title
    Pacing thresholds at 6 months
    Title
    Pacing impedances at 6 months
    Title
    R-wave amplitudes at 6 months
    Title
    6-month complication free rate
    Secondary Outcome Measure Information:
    Title
    left ventricular bipolar pacing and sensing with RENEWAL 3 H173 safety

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Moderate to severe heart failure (NYHA Class III/IV) including left ventricular dysfunction (EF <= 35%) and QRS duration >= 120 ms remaining symptomatic despite stable, optimal heart failure drug therapy. 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 investigational center and at the intervals defined by this protocol. Exclusion Criteria: A known hypersensitivity to a 1.0 mg (0.5 mg per electrode) dose of dexamethasone acetate. Previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted LV lead placement. Pre-existing cardioversion/defibrillation leads other than those specified in this investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads). Requiring dialysis. A myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment. Hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis). A documented life expectancy of less than 6 months or expected to undergo heart transplant within 6 months. Enrolled in any concurrent study, without prior Guidant written approval, that may confound the results of this study. Have a mechanical tricuspid heart valve.

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead

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