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Model 4196 Left Ventricular (LV) Lead Chronic Performance Study

Sponsor
Medtronic (Industry)
Overall Status
Completed
CT.gov ID
NCT00930904
Collaborator
(none)
1,847
Enrollment
103
Locations
94
Duration (Months)
17.9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate long-term performance of the 4196 LV Lead. This evaluation is based on the number of lead-related complications occurring 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 4196 LV Lead and is integrated within the Product Surveillance Registry (PAN Registry).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Model 4196 LV lead complication-free survivability will be summarized.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1847 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Attain Ability® Model 4196 Left Ventricular Lead Chronic Performance Post Approval Study
    Study Start Date :
    Jun 1, 2009
    Actual Primary Completion Date :
    Apr 1, 2017
    Actual Study Completion Date :
    Apr 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Lead-related complication rate [5 years]

    Secondary Outcome Measures

    1. Types of lead-related events [5 years]

    2. Percent of subjects with changes in electrode programming [5 Years]

    3. Percent of fractures with loss of function [5 years]

    4. Mean bipolar pacing threshold [1 year]

    5. Mean pacing threshold and impedance via Tip and Ring unipolar pacing configurations [1 year]

    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 Ability Model 4196 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 Birmingham Alabama United States
    2 Anchorage Alaska United States
    3 Gilbert Arizona United States
    4 Phoenix Arizona United States
    5 Scottsdale Arizona United States
    6 Little Rock Arkansas United States
    7 Bakersfield California United States
    8 Chula Vista California United States
    9 Downey California United States
    10 East Palo Alto California United States
    11 Long Beach California United States
    12 Salinas California United States
    13 San Bernardino California United States
    14 Torrance California United States
    15 Van Nuys California United States
    16 Colorado Springs Colorado United States
    17 Denver Colorado United States
    18 Newark Delaware United States
    19 Washington District of Columbia United States
    20 Bradenton Florida United States
    21 Clearwater Florida United States
    22 Jacksonville Florida United States
    23 Melbourne Florida United States
    24 Wellington Florida United States
    25 Atlanta Georgia United States
    26 Columbus Georgia United States
    27 Marietta Georgia United States
    28 Oak Lawn Illinois United States
    29 Evansville Indiana United States
    30 Indianapolis Indiana United States
    31 Des Moines Iowa United States
    32 Kansas City Kansas United States
    33 Lexington Kentucky United States
    34 Louisville Kentucky United States
    35 Alexandria Louisiana United States
    36 Baton Rouge Louisiana United States
    37 Baltimore Maryland United States
    38 Salisbury Maryland United States
    39 Silver Spring Maryland United States
    40 Takoma Park Maryland United States
    41 Worcester Massachusetts United States
    42 Grand Blanc Michigan United States
    43 Marquette Michigan United States
    44 Saginaw Michigan United States
    45 Ypsilanti Michigan United States
    46 Robbinsdale Minnesota United States
    47 Rochester Minnesota United States
    48 Columbia Missouri United States
    49 Kansas City Missouri United States
    50 Lebanon New Hampshire United States
    51 Browns Mills New Jersey United States
    52 Ocean City New Jersey United States
    53 Parlin New Jersey United States
    54 West Orange New Jersey United States
    55 Albuquerque New Mexico United States
    56 Huntington New York United States
    57 Utica New York United States
    58 Durham North Carolina United States
    59 Greensboro North Carolina United States
    60 Hickory North Carolina United States
    61 Winston-Salem North Carolina United States
    62 Fargo North Dakota United States
    63 Akron Ohio United States
    64 Cincinnati Ohio United States
    65 Cleveland Ohio United States
    66 Columbus Ohio United States
    67 Toledo Ohio United States
    68 Portland Oregon United States
    69 Erie Pennsylvania United States
    70 Lancaster Pennsylvania United States
    71 Sayre Pennsylvania United States
    72 Charleston South Carolina United States
    73 Columbia South Carolina United States
    74 Florence South Carolina United States
    75 Chattanooga Tennessee United States
    76 Germantown Tennessee United States
    77 Kingsport Tennessee United States
    78 Nashville Tennessee United States
    79 Amarillo Texas United States
    80 Austin Texas United States
    81 Dallas Texas United States
    82 Fort Worth Texas United States
    83 Houston Texas United States
    84 San Antonio Texas United States
    85 The Woodlands Texas United States
    86 Burlington Vermont United States
    87 Fairfax Virginia United States
    88 Olympia Washington United States
    89 Spokane Washington United States
    90 Madison Wisconsin United States
    91 Milwaukee Wisconsin United States
    92 Linz Austria
    93 Hasselt Belgium
    94 Ottawa Ontario Canada
    95 Ste-Foy Quebec Canada
    96 Kingston Canada
    97 Toronto Canada
    98 Marseille France
    99 Reggio Emilia Italy
    100 Udine Italy
    101 Eindhoven Netherlands
    102 Rotterdam Netherlands
    103 Valencia Spain

    Sponsors and Collaborators

    • Medtronic

    Investigators

    • Study Chair: 4196 LV Lead Chronic Performance Study Team, Medtronic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medtronic
    ClinicalTrials.gov Identifier:
    NCT00930904
    Other Study ID Numbers:
    • 4196 Chronic Performance
    First Posted:
    Jul 2, 2009
    Last Update Posted:
    Dec 27, 2017
    Last Verified:
    Dec 1, 2017
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Dec 27, 2017