Clincosm LogoSign in Get a demo

PSR-REVERSE: The Product Surveillance Registry REVERSE Post Approval Study

Sponsor
Medtronic (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT01660035
Collaborator
(none)
155
Enrollment
123
Locations
119
Anticipated Duration (Months)
1.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the REVERSE Post Approval Study (PAS) is to confirm the benefit observed in the REVERSE and RAFT pivotal studies in "real-world" clinical practice.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The REVERSE PAS will estimate the 3-year survival probability of freedom from heart failure hospitalization and heart failure events in patients implanted with a Medtronic CRT-D device who meet the expanded indication criteria with a QRS duration ≤ 150 ms.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    155 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE) Post Approval Study
    Actual Study Start Date :
    Apr 1, 2012
    Anticipated Primary Completion Date :
    Mar 1, 2022
    Anticipated Study Completion Date :
    Mar 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Survival from Heart Failure Hospitalization and All-Cause Mortality [3 years]

      To estimate the 3-year survival probability of freedom from heart failure hospitalization or all-cause death for patients implanted with a Medtronic CRT-D device meeting the approved expanded indication criteria with a QRS duration ≤ 150ms.

    2. Survival from Heart Failure Event and All-Cause Mortality [3 years]

      To estimate the 3-year survival probability of freedom from heart failure event or all- cause death for patients implanted with a Medtronic CRT-D device meeting the approved expanded indication criteria with a QRS duration ≤ 150ms.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 or be treated with a Medtronic CRT-D who meets the expanded CRT-D indication criteria with a QRS ≤ 150ms

    • Patient within 30 days of implant

    Exclusion Criteria:

    • Patient who is, or will 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 Little Rock Arkansas United States 72205
    7 Bakersfield California United States 93301
    8 Chula Vista California United States 91910
    9 Los Angeles California United States 90048
    10 Rancho Mirage California United States 92270
    11 Redwood City California United States 94062
    12 Salinas California United States 93901
    13 San Diego California United States 92103
    14 Stanford California United States 94305
    15 Torrance California United States 90503
    16 Van Nuys California United States 91405
    17 Colorado Springs Colorado United States 80907
    18 Lakewood Colorado United States 80228
    19 New Haven Connecticut United States 06519
    20 Washington District of Columbia United States 20010
    21 Bradenton Florida United States 34205
    22 Clearwater Florida United States 33756
    23 Jacksonville Florida United States 32216
    24 Safety Harbor Florida United States 34695
    25 Albany Georgia United States 31701
    26 Atlanta Georgia United States 30308
    27 Marietta Georgia United States 30060
    28 Evansville Indiana United States 47710
    29 West Des Moines Iowa United States 50266
    30 Kansas City Kansas United States 66160
    31 Edgewood Kentucky United States 41017
    32 Lexington Kentucky United States 40503
    33 Louisville Kentucky United States 40207
    34 Baton Rouge Louisiana United States 70808
    35 Hyattsville Maryland United States 20782
    36 Salisbury Maryland United States 21804
    37 Silver Spring Maryland United States 20910
    38 Takoma Park Maryland United States 20912
    39 Lansing Michigan United States 48912
    40 Marquette Michigan United States 49855
    41 Ypsilanti Michigan United States 48197
    42 Coon Rapids Minnesota United States 55433
    43 Minneapolis Minnesota United States 55407
    44 Robbinsdale Minnesota United States 55422
    45 Rochester Minnesota United States 55905
    46 Saint Cloud Minnesota United States 56303
    47 Saint Paul Minnesota United States 55102
    48 Hattiesburg Clinic Hattiesburg Mississippi United States 39401
    49 Columbia Missouri United States 65201
    50 Kansas City Missouri United States 64111
    51 Lebanon New Hampshire United States 03766
    52 Morristown New Jersey United States 07960
    53 Ocean City New Jersey United States 07712
    54 Ridgewood New Jersey United States 07450
    55 Albuquerque New Mexico United States 87106
    56 Bay Shore New York United States 11706
    57 Bronx New York United States
    58 Huntington New York United States 11743
    59 Manhasset New York United States 11030
    60 New Hyde Park New York United States 11040
    61 New York New York United States 10075
    62 Poughkeepsie New York United States 12601
    63 Staten Island New York United States 10305
    64 Utica New York United States 13501
    65 Charlotte North Carolina United States 28203
    66 Durham North Carolina United States 27705
    67 Raleigh North Carolina United States 27610
    68 Akron Ohio United States 44304
    69 Cincinnati Ohio United States 45219
    70 Cleveland Ohio United States 44195
    71 Columbus Ohio United States 43210
    72 Toledo Ohio United States 43608
    73 Oklahoma City Oklahoma United States 73120
    74 Portland Oregon United States 97220
    75 Allentown Pennsylvania United States 18103
    76 Bethlehem Pennsylvania United States 18017
    77 Danville Pennsylvania United States 17822
    78 Erie Pennsylvania United States 16550
    79 Lancaster Pennsylvania United States 17604
    80 Philadelphia Pennsylvania United States 19104
    81 Pittsburgh Pennsylvania United States 15213
    82 Wilkes-Barre Pennsylvania United States 18711
    83 Wynnewood Pennsylvania United States 19096
    84 Columbia South Carolina United States 29204
    85 Germantown Tennessee United States 38138
    86 Nashville Tennessee United States 37212
    87 Austin Texas United States 78705
    88 Dallas Texas United States 75226
    89 Fort Worth Texas United States 76104
    90 Houston Texas United States 77030
    91 Plano Texas United States 75093
    92 San Antonio Texas United States 78229
    93 The Woodlands Texas United States 77384
    94 Burlington Vermont United States 05401
    95 Charlottesville Virginia United States 22908
    96 Falls Church Virginia United States 22042
    97 Leesburg Virginia United States 20176
    98 Olympia Washington United States 98506
    99 Spokane Washington United States 99204
    100 Tacoma Washington United States 98402
    101 Madison Wisconsin United States 53715
    102 Milwaukee Wisconsin United States 53215
    103 Leuven Belgium
    104 Calgary Alberta Canada T2N 4N1
    105 London Ontario Canada
    106 Ottawa Ontario Canada
    107 Montreal Quebec Canada
    108 Quebec City Quebec Canada
    109 La Rochelle France
    110 Nantes France
    111 Essen Germany
    112 Hannover Germany
    113 Homburg Germany
    114 Ulm Germany
    115 Reggio Emilia Italy
    116 Eindhoven Netherlands
    117 Maastricht Netherlands
    118 Nieuwegein Netherlands
    119 Rotterdam Netherlands
    120 Skovde Sweden
    121 Zurich Switzerland
    122 Liverpool United Kingdom
    123 Middlesborough 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:
    NCT01660035
    Other Study ID Numbers:
    • PSR-REVERSE
    First Posted:
    Aug 8, 2012
    Last Update Posted:
    Feb 7, 2022
    Last Verified:
    Feb 1, 2022
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Feb 7, 2022