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Model 4195 Left Ventricular (LV) Lead Chronic Performance Study

Sponsor
Medtronic (Industry)
Overall Status
Completed
CT.gov ID
NCT00869921
Collaborator
(none)
1,322
Enrollment
67
Locations
109.1
Duration (Months)
19.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluate long-term performance of the 4195 LV Lead. This evaluation is based on the number of lead-related complications occuring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4195 LV Lead and is integrated within Medtronic's post-market surveillance platform.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Model 4195 LV lead complication-free survivability will be summarized.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1322 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Attain StarFix® Model 4195 Left Ventricular Lead Chronic Performance Post Approval Study
    Study Start Date :
    Mar 1, 2009
    Actual Primary Completion Date :
    Apr 3, 2018
    Actual Study Completion Date :
    Apr 3, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Lead-related complication rate. [Implant to 5 years post-implant.]

    Secondary Outcome Measures

    1. Types of Model 4195 lead-related events [5 years post implant]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.

    Inclusion Criteria

    • Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements

    • Patient has or is intended to receive an Attain StarFix Model 4195 LV lead

    • Patient within 30 day post implant enrollment window

    Exclusion Criteria

    • Patient who is, or is expected to be inaccessible for follow-up

    • Patient with exclusion criteria required by local law

    • Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anchorage Alaska United States
    2 Phoenix Arizona United States
    3 Scottsdale Arizona United States
    4 Chula Vista California United States
    5 Redding California United States
    6 Salinas California United States
    7 Stanford California United States
    8 Torrance California United States
    9 Colorado Springs Colorado United States
    10 New Haven Connecticut United States
    11 Bradenton Florida United States
    12 Clearwater Florida United States
    13 Jacksonville Florida United States
    14 Melbourne Florida United States
    15 Albany Georgia United States
    16 Marietta Georgia United States
    17 Indianapolis Indiana United States
    18 Newburgh Indiana United States
    19 Des Moines Iowa United States
    20 Kansas City Kansas United States
    21 Edgewood Kentucky United States
    22 Louisville Kentucky United States
    23 Baton Rouge Louisiana United States
    24 Covington Louisiana United States
    25 Salisbury Maryland United States
    26 Silver Spring Maryland United States
    27 Takoma Park Maryland United States
    28 Boston Massachusetts United States
    29 Grand Blanc Michigan United States
    30 Marquette Michigan United States
    31 Robbinsdale Minnesota United States
    32 Rochester Minnesota United States
    33 Saint Louis Park Minnesota United States
    34 Columbia Missouri United States
    35 Kansas City Missouri United States
    36 Henderson Nevada United States
    37 West Orange New Jersey United States
    38 Albuquerque New Mexico United States
    39 New York New York United States
    40 Durham North Carolina United States
    41 Fargo North Dakota United States
    42 Cincinnati Ohio United States
    43 Cleveland Ohio United States
    44 Columbus Ohio United States
    45 Toledo Ohio United States
    46 Portland Oregon United States
    47 Lancaster Pennsylvania United States
    48 Germantown Tennessee United States
    49 Kingsport Tennessee United States
    50 Nashville Tennessee United States
    51 Austin Texas United States
    52 Dallas Texas United States
    53 Fort Worth Texas United States
    54 Houston Texas United States
    55 Plano Texas United States
    56 San Antonio Texas United States
    57 Burlington Vermont United States
    58 Falls Church Virginia United States
    59 Olympia Washington United States
    60 Spokane Washington United States
    61 Madison Wisconsin United States
    62 Milwaukee Wisconsin United States
    63 Calgary Alberta Canada
    64 Kingston Ontario Canada
    65 Ottawa Ontario Canada
    66 Quebec City Quebec Canada
    67 Middlesbrough United Kingdom

    Sponsors and Collaborators

    • Medtronic

    Investigators

    • Study Chair: 4195 LV Lead Chronic Performance Study Team, Medtronic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medtronic
    ClinicalTrials.gov Identifier:
    NCT00869921
    Other Study ID Numbers:
    • 4195 Chronic Performance
    First Posted:
    Mar 26, 2009
    Last Update Posted:
    Sep 13, 2018
    Last Verified:
    Sep 1, 2018
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Sep 13, 2018