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Model 4296 Left Ventricular (LV) Lead Chronic Performance Study

Sponsor
Medtronic (Industry)
Overall Status
Completed
CT.gov ID
NCT01361672
Collaborator
(none)
1,140
Enrollment
99
Locations
98
Actual Duration (Months)
11.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Lead survivability will be summarized.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The purpose of this study is to evaluate long-term performance of the 4296 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 4296 LV Lead. This study is conducted within Medtronic's post-market surveillance platform.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1140 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Attain Ability® Family Left Ventricular Lead Chronic Performance Study
    Actual Study Start Date :
    May 1, 2011
    Actual Primary Completion Date :
    Jul 1, 2019
    Actual Study Completion Date :
    Jul 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Model 4296 LV Lead-related complication rate [5 years]

      To demonstrate that the Model 4296 lead-related complication-free probability

    Secondary Outcome Measures

    1. Types of lead-related adverse device effects [5 years]

      To summarize all lead related adverse events

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

      To characterize any changes in electrical programming

    3. Number of fractures with and without loss of function [5 years]

      To characterize fractures with and without loss of function

    4. Bipolar electrical performance at 1 year [1 year]

      To summarize bipolar electrical performance at one year post implant

    5. Bipolar pacing impedance [1 year]

      To characterize threshold measurements and impedance for both conductors

    6. Bipolar pacing capture threshold [1 year]

      To characterize standard bipolar pacing voltage thresholds

    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 4296 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 35294
    2 Anchorage Alaska United States 99508
    3 Chandler Arizona United States 85226
    4 Gilbert Arizona United States 85295
    5 Phoenix Arizona United States 85006
    6 Jonesboro Arkansas United States 72410
    7 Little Rock Arkansas United States 72205
    8 Bakersfield California United States 93309
    9 Chula Vista California United States 91910
    10 Monterey California United States 93940
    11 Rancho Mirage California United States 92270
    12 Redding California United States 96001
    13 Redwood City California United States 94062
    14 Salinas California United States 93901
    15 San Diego California United States 92103
    16 San Francisco California United States 94143
    17 Stanford California United States 94305
    18 Torrance California United States 90503
    19 Van Nuys California United States 91405
    20 Colorado Springs Colorado United States 80907
    21 Lakewood Colorado United States 80228
    22 New Haven Connecticut United States 06519
    23 Newark Delaware United States 19713
    24 Washington District of Columbia United States 20010
    25 Bradenton Florida United States 34205
    26 Clearwater Florida United States 33756
    27 Jacksonville Florida United States 32216
    28 Melbourne Florida United States 32901
    29 Safety Harbor Florida United States 34695
    30 Tampa Florida United States 33607
    31 Indianapolis Indiana United States 46202
    32 West Des Moines Iowa United States 50266
    33 Kansas City Kansas United States 66160
    34 Lexington Kentucky United States 40503
    35 Louisville Kentucky United States 40207
    36 Baton Rouge Louisiana United States 70808
    37 New Orleans Louisiana United States 70121
    38 Hyattsville Maryland United States 20782
    39 Silver Spring Maryland United States 20910
    40 Takoma Park Maryland United States 20912
    41 Worcester Massachusetts United States 01605
    42 Lansing Michigan United States 48912
    43 Marquette Michigan United States 49855
    44 Ypsilanti Michigan United States 48197
    45 Robbinsdale Minnesota United States 55422
    46 Rochester Minnesota United States 55905
    47 Saint Louis Park Minnesota United States 55416
    48 Columbia Missouri United States 65201
    49 Kansas City Missouri United States 64111
    50 Saint Louis Missouri United States 63110
    51 Henderson Nevada United States 89052
    52 Las Vegas Nevada United States 89169
    53 Lebanon New Hampshire United States 03766
    54 Morristown New Jersey United States 07960
    55 Ocean City New Jersey United States 07712
    56 West Orange New Jersey United States 07052
    57 Albuquerque New Mexico United States 87106
    58 Garden City New York United States 11530
    59 Huntington New York United States 11743
    60 New York New York United States 10016
    61 Poughkeepsie New York United States 12601
    62 Utica New York United States 13501
    63 Durham North Carolina United States 27705
    64 Greensboro North Carolina United States 27610
    65 Winston-Salem North Carolina United States 27157
    66 Fargo North Dakota United States 58122
    67 Akron Ohio United States 44304
    68 Cincinnati Ohio United States 45219
    69 Cleveland Ohio United States 44195
    70 Toledo Ohio United States 43608
    71 Allentown Pennsylvania United States 18103
    72 Danville Pennsylvania United States 17822
    73 Erie Pennsylvania United States 16550
    74 Lancaster Pennsylvania United States 17604
    75 Philadelphia Pennsylvania United States 19104
    76 Pittsburgh Pennsylvania United States 15213
    77 Wilkes-Barre Pennsylvania United States 18711
    78 Columbia South Carolina United States 29204
    79 Germantown Tennessee United States 38138
    80 Kingsport Tennessee United States 37660
    81 Nashville Tennessee United States 37203
    82 Austin Texas United States 78705
    83 Dallas Texas United States 75226
    84 Houston Texas United States 77030
    85 Plano Texas United States 75093
    86 San Antonio Texas United States 78229
    87 The Woodlands Texas United States 77384
    88 Falls Church Virginia United States 22042
    89 Leesburg Virginia United States 20176
    90 Olympia Washington United States 98506
    91 Spokane Washington United States 99204
    92 Tacoma Washington United States 98402
    93 Madison Wisconsin United States 53715
    94 Milwaukee Wisconsin United States 53215
    95 Ottawa Ontario Canada K1Y 4W7
    96 Peterborough Ontario Canada K9J 0B2
    97 Montreal Quebec Canada H2W 1T8
    98 Quebec Canada G1V 4G5
    99 Essen Germany 45147

    Sponsors and Collaborators

    • Medtronic

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medtronic
    ClinicalTrials.gov Identifier:
    NCT01361672
    Other Study ID Numbers:
    • 4296 Chronic Performance
    First Posted:
    May 27, 2011
    Last Update Posted:
    Jul 22, 2019
    Last Verified:
    Jul 1, 2019
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Jul 22, 2019