Attain Performa™ Left Ventricular (LV) Quadripolar Leads Chronic Performance Study

Sponsor
Medtronic (Industry)
Overall Status
Completed
CT.gov ID
NCT02294331
Collaborator
(none)
1,900
100
84
19
0.2

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 Attain Performa™ LV Leads. 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 Attain Performa™ LV Leads. This study is conducted within Medtronic's post-market surveillance platform.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1900 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Attain Performa™ Left Ventricular Quadripolar Lead Post-Approval Study
    Actual Study Start Date :
    Aug 1, 2014
    Actual Primary Completion Date :
    Jul 31, 2021
    Actual Study Completion Date :
    Jul 31, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Attain Performa™ LV Leads

    Patients who meet all Inclusion criteria and no Exclusion criteria and are implanted with an Attain Performa™ LV lead.

    Outcome Measures

    Primary Outcome Measures

    1. Lead complication [5 years]

      Survival analysis will be used to analyze the lead. Lead status will be reported as a function of time post-implant for all leads in the study. Lead related complications include but are not limited to: failure to capture, abnormal sensing, threshold rise, abnormal impedance, insulation breach, conductor fracture, extracardiac stimulation, lead dislodgement, cardiac perforation, structural lead failure.

    Secondary Outcome Measures

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

      Summary statistics will be used to report types and rates of lead related adverse device effects (ADE). Examples of ADEs include but are not limited to: failure to capture, abnormal sensing, threshold rise, abnormal impedance, insulation breach, conductor fracture, extracardiac stimulation, lead dislodgement, cardiac perforation, structural lead failure.

    2. Returned lead analysis [5 years]

      A listing of analysis results of all Attain Performa study leads which are explanted and returned for analysis will be reported.

    3. Lead survival estimate by model [5 years]

      An analysis will be conducted at the end of the study to provide comparative statistics on the safety performance of each individual lead model.

    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 Performa™ 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 Jonesboro Arkansas United States 72410
    6 Bakersfield California United States 93301
    7 Rancho Mirage California United States 92270
    8 Redwood City California United States 94062
    9 Salinas California United States 93901
    10 San Diego California United States 92103
    11 Stanford California United States 94305
    12 Torrance California United States 90503
    13 Van Nuys California United States 91405
    14 Colorado Springs Colorado United States 80907
    15 Lakewood Colorado United States 80228
    16 New Haven Connecticut United States 06519
    17 Washington District of Columbia United States 20010
    18 Bradenton Florida United States 34205
    19 Clearwater Florida United States 33756
    20 Jacksonville Florida United States 32216
    21 Safety Harbor Florida United States 34695
    22 Albany Georgia United States 31701
    23 Marietta Georgia United States 30060
    24 Evansville Indiana United States 47710
    25 West Des Moines Iowa United States 50266
    26 Kansas City Kansas United States 66160
    27 Edgewood Kentucky United States 41017
    28 Lexington Kentucky United States 40503
    29 Louisville Kentucky United States 40207
    30 Baton Rouge Louisiana United States 70808
    31 Hyattsville Maryland United States 20782
    32 Salisbury Maryland United States 21804
    33 Silver Spring Maryland United States 20910
    34 Takoma Park Maryland United States 20912
    35 Lansing Michigan United States 48912
    36 Marquette Michigan United States 49855
    37 Ypsilanti Michigan United States 48197
    38 Minneapolis Minnesota United States 55407
    39 Robbinsdale Minnesota United States 55422
    40 Rochester Minnesota United States 554905
    41 Hattiesburg Clinic Hattiesburg Mississippi United States
    42 Columbia Missouri United States 65201
    43 Kansas City Missouri United States 64111
    44 Saint Louis Missouri United States 63110
    45 Las Vegas Nevada United States 89169
    46 Lebanon New Hampshire United States 03766
    47 Morristown New Jersey United States 07960
    48 Albuquerque New Mexico United States 87106
    49 Huntington New York United States 11743
    50 New York New York United States 10032
    51 Poughkeepsie New York United States 12601
    52 Utica New York United States 13501
    53 Charlotte North Carolina United States 28203
    54 Durham North Carolina United States 27705
    55 Raleigh North Carolina United States 27610
    56 Akron Ohio United States 44304
    57 Cincinnati Ohio United States 45219
    58 Cleveland Ohio United States 44195
    59 Toledo Ohio United States 43608
    60 Portland Oregon United States 97220
    61 Allentown Pennsylvania United States 18103
    62 St Luke's University Health Network Bethlehem Pennsylvania United States
    63 Danville Pennsylvania United States 17822
    64 Erie Pennsylvania United States 16550
    65 Philadelphia Pennsylvania United States 19104
    66 Pittsburgh Pennsylvania United States 15213
    67 Wilkes-Barre Pennsylvania United States 18711
    68 Germantown Tennessee United States 38138
    69 Nashville Tennessee United States 37203
    70 Austin Texas United States 78705
    71 Dallas Texas United States 75226
    72 Fort Worth Texas United States 76104
    73 Houston Texas United States 77030
    74 Plano Texas United States 75093
    75 The Woodlands Texas United States 77384
    76 Burlington Vermont United States 05401
    77 Falls Church Virginia United States 22042
    78 Leesburg Virginia United States 20176
    79 Spokane Washington United States 99204
    80 Madison Wisconsin United States 53715
    81 Milwaukee Wisconsin United States 53215
    82 Leuven Belgium
    83 Calgary Alberta Canada
    84 London Ontario Canada
    85 Montreal Quebec Canada
    86 Calgary Canada
    87 Ottawa Canada
    88 Quebec Canada
    89 La Rochelle France
    90 Nantes France
    91 Essen Germany
    92 Hannover Germany
    93 Ulm Germany
    94 Eindhoven Netherlands
    95 Maastricht Netherlands
    96 Nieuwegein Netherlands
    97 Rotterdam Netherlands
    98 Zurich Switzerland
    99 Liverpool United Kingdom
    100 Middlesbrough United Kingdom

    Sponsors and Collaborators

    • Medtronic

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medtronic
    ClinicalTrials.gov Identifier:
    NCT02294331
    Other Study ID Numbers:
    • Attain Performa™ PAS
    First Posted:
    Nov 19, 2014
    Last Update Posted:
    Feb 1, 2022
    Last Verified:
    Jan 1, 2022
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 1, 2022