Model 4396 Left Ventricular (LV) Lead Chronic Performance Study

Sponsor
Medtronic (Industry)
Overall Status
Completed
CT.gov ID
NCT01361685
Collaborator
(none)
366
52
117.2
7
0.1

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 4396 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 4396 LV Lead. This study is conducted within Medtronic's post-market surveillance platform.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    366 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Attain Ability® Family Left Ventricular Lead Chronic Performance Study
    Study Start Date :
    May 1, 2011
    Actual Primary Completion Date :
    Mar 2, 2020
    Actual Study Completion Date :
    Feb 4, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Model 4396 LV Lead-related complication rate [5 years]

    Secondary Outcome Measures

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

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

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

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

    5. Bipolar pacing impedance [1 year]

    6. Bipolar pacing capture threshold [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 4396 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 Southwest EP Clinic Gilbert Arizona United States 85295
    2 Saint Vincent Heart Clinic Arkansas Little Rock Arkansas United States 72205
    3 Eisenhower Desert Cardiology Center Rancho Mirage California United States 92270
    4 COR Healthcare Torrance California United States 90503
    5 Cardiovascular Consultants Medical Group Van Nuys California United States 91405
    6 Colorado Heart and Vascular, PC Lakewood Colorado United States 80228
    7 Yale University New Haven Connecticut United States 06519
    8 MedStar Southern Maryland Hospital Center Washington District of Columbia United States 20010
    9 Bradenton Cardiology Bradenton Florida United States 34205
    10 Baptist Heart Specialists Jacksonville Florida United States 32216
    11 Indiana University Health - Methodist Research Institute Indianapolis Indiana United States 46202
    12 Iowa Heart Center West Des Moines Iowa United States 50266
    13 Louisville Cardiology Group Louisville Kentucky United States 40207
    14 Cenla Heart Specialists Alexandria Louisiana United States 71301
    15 Our Lady of the Lake Office of Research Baton Rouge Louisiana United States 70808
    16 Michigan Heart Ypsilanti Michigan United States 48197
    17 Metropolitan Cardiology Consultants PA Coon Rapids Minnesota United States 55433
    18 Minneapolis Heart Institute Foundation Minneapolis Minnesota United States 55407
    19 North Memorial Heart and Vascular Institute Robbinsdale Minnesota United States 55422
    20 HealthCare Partners Medical Group Saint Louis Park Minnesota United States 55416
    21 Saint Lukes Health System Kansas City Missouri United States 64111
    22 Washington University Saint Louis Missouri United States 63110
    23 Patients First Health Care LLC Washington Missouri United States 63090
    24 New Jersey Cardiology Associates West Orange New Jersey United States 07052
    25 Presbyterian Heart Group Albuquerque New Mexico United States 87106
    26 NYU Langone Medical Center New York New York United States 10016
    27 New York-Presbyterian Hospital/Columbia University Medical Center New York New York United States 10032
    28 New York-Presbyterian Hospital/Weill Cornell Medical Center New York New York United States 10065
    29 Central New York Cardiology Utica New York United States 13501
    30 WakeMed Health & Hospitals Raleigh North Carolina United States 27610
    31 The Christ Hospital Health Network Cincinnati Ohio United States 45219
    32 University of Cincinnati Cincinnati Ohio United States 45267
    33 Cleveland Clinic Cleveland Ohio United States 44195
    34 Lehigh Valley Health Network Allentown Pennsylvania United States 18103
    35 Lehigh Valley Health Network Bethlehem Pennsylvania United States 18017
    36 Medicor Associates Erie Pennsylvania United States 16507
    37 Lancaster General Hospital Lancaster Pennsylvania United States 17603
    38 Geisinger Wyoming Valley Medical Center Wilkes-Barre Pennsylvania United States 18711
    39 Wellmont CVA Heart Institute Kingsport Tennessee United States 37660
    40 Saint Thomas Research Institute Nashville Tennessee United States 37205
    41 Texas Cardiac Arrhythmia Research Foundation Austin Texas United States 78705
    42 Baylor Research Institute Dallas Texas United States 75206
    43 Houston Methodist Hospital Houston Texas United States 77030
    44 Baylor Research Institute Plano Texas United States 75093
    45 STAR Clinical Trials San Antonio Texas United States 78229
    46 EP Heart LLC The Woodlands Texas United States 77384
    47 The University of Vermont Medical Center Burlington Vermont United States 05401
    48 Aurora Cardiovascular Services Milwaukee Wisconsin United States 53215
    49 Queen's University & Kingston General Hospital Kingston Ontario Canada K7L 3N6
    50 Centre Hospitalier de l'Universite de Montreal (CHUM) Hopital Hotel-Dieu Montreal Quebec Canada H2W 1T8
    51 Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ) Quebec Canada G1V 4G5
    52 Universitatsklinikum Ulm Ulm Baden-württemberg Germany 89081

    Sponsors and Collaborators

    • Medtronic

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medtronic
    ClinicalTrials.gov Identifier:
    NCT01361685
    Other Study ID Numbers:
    • 4396 Chronic Performance
    First Posted:
    May 27, 2011
    Last Update Posted:
    Feb 17, 2021
    Last Verified:
    Feb 1, 2021
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 17, 2021