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Quad PAS: Quadripolar Pacing Post Approval Study

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Completed
CT.gov ID
NCT01555619
Collaborator
(none)
1,971
Enrollment
71
Locations
84.4
Actual Duration (Months)
27.8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this post-approval study is to evaluate the acute and chronic performance of a Quadripolar CRT-D device system in a patient population indicated for cardiac resynchronization therapy (CRT).

Condition or Disease Intervention/Treatment Phase
  • Device: CRT-D System

Detailed Description

Quad PAS is a multi-center, post-approval study. Patients who meet inclusion/exclusion criteria will have an attempted implant of a Quadripolar CRT-D device system (device and left ventricular (LV) lead). Patients who have an unsuccessful implant will be followed for 30 days for any adverse events and then withdrawn from the study, or may have an implant reattempted if the physician chooses to do so. Patients enrolled in the study will be followed at 6 months, and every 6 months thereafter, for 60 months of follow up (5 years). After patients complete 60 months of follow-up, their participation in the study will be terminated.

Study Design

Study Type:
Observational
Actual Enrollment :
1971 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Quadripolar Pacing Post Approval Study
Actual Study Start Date :
Feb 15, 2012
Actual Primary Completion Date :
Feb 28, 2019
Actual Study Completion Date :
Feb 28, 2019

Arms and Interventions

Arm Intervention/Treatment
CRT-D System

St. Jude Medical (SJM) Promote® Q/Promote® Quadra/Unify Quadra™ CRT-D system.

Device: CRT-D System
Implantation of a CRT-D System
Other Names:
  • CRT-D and LV pacing lead

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Complication free survival rate related to the CRT-D system [5 years]

      Complication free survival rate through 5 years for complications related to the CRT-D system

    2. Complication free survival rate related to the LV lead [5 years]

      Complication free survival rate at 5 years for complications related to the LV lead

    3. Mean programmed LV lead pacing capture threshold [5 years]

      Mean programmed LV lead pacing capture threshold at 5 years

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Approved indication per current American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for implantation of a CRT-D system for treatment of heart failure or life threatening ventricular tachyarrhythmia(s).

    2. Participated in the Promote® Q CRT-D and Quartet™ Left Ventricular Heart Lead Study (Investigational Device Exemption (IDE) study), or are receiving a new Quadripolar CRT-D device system implant or are undergoing an upgrade from an existing implantable cardioverter-defibrillator or pacemaker implant with no prior LV lead placement.

    3. Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations

    Exclusion Criteria:

    1. Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate

    2. Have a life expectancy of less than 5 years due to any condition

    3. Be less than 18 years of age

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cardiology, P.C. Birmingham Alabama United States 35211
    2 Heart Center Research, LLC/Research Center Huntsville Alabama United States 35801
    3 Southeastern Cardiology Consultants PC Montgomery Alabama United States 36116
    4 Arizona Arrhythmia Research Center Phoenix Arizona United States 85006
    5 Washington Regional Medical Center Fayetteville Arkansas United States 72703
    6 Arkansas Heart Hospital Little Rock Arkansas United States 72211
    7 Comprehensive Cardiovascular Bakersfield California United States 93309
    8 Scripps Green Hospital La Jolla California United States 92037
    9 USC Unversity Hospital Los Angeles California United States 90033
    10 Fogarty Institute Mountain View California United States 94040
    11 Premier Cardiology, Inc. Newport Beach California United States 92663
    12 Cardiac Rhythm Specialists, Inc. Northridge California United States 91325
    13 St. Joseph Heritage Medical Group Orange California United States 92868
    14 Regional Cardiology Associates Sacramento California United States 95819
    15 St. Joseph's Medical Center Stockton California United States 95204
    16 Cardiology Associates Medical Group, Inc. Ventura California United States 93003
    17 Florida Electrophysiology Associates Atlantis Florida United States 33462
    18 Yoel R. Vivas, MD Boynton Beach Florida United States 33437
    19 Jorge Diaz Lake Mary Florida United States 32746
    20 Naples Heart Rhythm Specialists Naples Florida United States 34102
    21 Munroe Regional Medical Center Ocala Florida United States 34471
    22 Florida Heart Rhythm Specialists, LLC Plantation Florida United States 33324
    23 Northside Hospital Saint Petersburg Florida United States 33709
    24 Cleveland Clinic Florida Weston Florida United States 33331
    25 Piedmont Heart Institue Atlanta Georgia United States 30309
    26 HeartCare Midwest Peoria Illinois United States 61614
    27 Parkview Research Center Fort Wayne Indiana United States 46805
    28 Northwest Indiana CardiovascularPhysicians, P.C. Munster Indiana United States 46321
    29 Unity Point Clinic Cedar Rapids Iowa United States 52403
    30 Central Baptist Hospital Lexington Kentucky United States 40503
    31 Northeast Cardiology Associates Bangor Maine United States 04401
    32 MedStar Health Research Institute Baltimore Maryland United States 21237
    33 Shady Grove Adventist Hospital Rockville Maryland United States 20850
    34 Lahey Clinic Burlington Massachusetts United States 01805
    35 Sinai Grace Hospital Detroit Michigan United States 48235
    36 Thoracic Cardio Healthcare Foundation Lansing Michigan United States 48910
    37 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
    38 The International Heart Institute of Montana Missoula Montana United States 59802
    39 Heart Consultants P.C. Omaha Nebraska United States 68122
    40 Cardiovascular Consultants of Nevada Las Vegas Nevada United States 89109
    41 Deborah Heart and Lung Center Browns Mills New Jersey United States 08015
    42 Cardiovascular Associates of the Delaware Valley Haddon Heights New Jersey United States 08035
    43 Presbyterian Heart Group Albuquerque New Mexico United States 87106
    44 Albany Medical College at Albany Medical Center Albany New York United States 12208
    45 Stonybrook University Medical Center Stony Brook New York United States 11794
    46 Buffalo Cardiology & Pulmonary Association Williamsville New York United States 14221
    47 University of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27599
    48 Caromount Heart Gastonia North Carolina United States 28054
    49 Sanford Research Fargo North Dakota United States 58122
    50 The Cleveland Clinic Foundation Cleveland Ohio United States 44195
    51 EMH Regional Medical Center Elyria Ohio United States 44035
    52 Integris Baptist Medical Center Oklahoma City Oklahoma United States 73112
    53 Bryn Mawr Medical Specialists Associates Bryn Mawr Pennsylvania United States 19010
    54 Saint Vincent Consultants in Cardiovascular Diseases Erie Pennsylvania United States 16502
    55 Lancaster General Hospital Lancaster Pennsylvania United States 17603
    56 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
    57 Pee Dee Cardiology Associates, PA Florence South Carolina United States 29506
    58 Cardiology Consultants Johnson City Tennessee United States 37601
    59 Cardiovascular Associates, PC Kingsport Tennessee United States 37660
    60 Arrythmia Consultants, P.C. Memphis Tennessee United States 38104
    61 St. Thomas Hospital Nashville Tennessee United States 37205
    62 HeartPlace Bedford Texas United States 76021
    63 Cardiology Associatesof Corpus Christi Corpus Christi Texas United States 78404
    64 Houston Arrhythmia Associates Houston Texas United States 77024
    65 Medicine School of University Health Care Salt Lake City Utah United States 84132
    66 Fletcher Allen Health Care - University Health Center Campus Burlington Vermont United States 05401
    67 Harrisonburg Medical Associations, Inc. Harrisonburg Virginia United States 22801
    68 Virginia Cardiovascular Specialists Richmond Virginia United States 23229
    69 Heart Clinics Northwest Spokane Washington United States 99204
    70 Morgantown Internal Medicine Group, Inc. Morgantown West Virginia United States 26505
    71 Aspirius Heart and Vascular Institute, Research and Education Wausau Wisconsin United States 54401

    Sponsors and Collaborators

    • Abbott Medical Devices

    Investigators

    • Study Chair: Raffaele Corbisiero, MD, Deborah Heart and Lung Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abbott Medical Devices
    ClinicalTrials.gov Identifier:
    NCT01555619
    Other Study ID Numbers:
    • 60030283
    First Posted:
    Mar 15, 2012
    Last Update Posted:
    Apr 16, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Abbott Medical Devices
    Left heart pacing lead
    Cardiac resynchronization therapy (CRT)
    Heart Failure
    Quadripolar pacing
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Apr 16, 2019