SJM MRI Diagnostic Imaging Registry (IDE)

Last updated: August 7, 2019
Sponsor: Abbott Medical Devices
Overall Status: Completed

Phase

N/A

Condition

Fast Heart Rate (Tachycardia)

Arrhythmia

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT02807948
SJM-CIP-10130
  • Ages > 18
  • All Genders

Study Summary

This study is a prospective, non-randomized, multi-center study of subjects implanted with an SJM pacemakers, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices who are clinically indicated for a non-thoracic MRI scan.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient is implanted with a market-released St. Jude Medical pacemaker, ICD, or CRTcurrent generation device listed in the study protocol and any market-released pacingor defibrillation lead.

  2. Patient's device and all leads must be implanted for at least 6 weeks prior to thescheduled date of the MRI.

  3. Patient has a clinical indication for a non-thoracic MRI scan, where MRI is theimaging modality of choice that will give adequate results to manage the patient.

  4. Patient is scheduled for a non-thoracic MRI scan up to 1.5T.

  5. Patient has a pacemaker, ICD, or CRT device implanted pectorally.

  6. Patient has the ability to provide informed consent for study participation and bewilling and able to comply with the study procedures.

  7. Patient is 18 years or above, or of legal age to give informed consent specific tostate and national law.

Exclusion

Exclusion Criteria:

  1. Patient has an ICD/CRT-D and is pacemaker dependent

  2. Capture threshold is greater than 2.5 volts at 0.5 ms for RA and RV leads

  3. Pacing lead impedance is NOT within range (i.e. ≥ 200 and ≤ 2000 ohms)

  4. High voltage lead impedance (HVLI) is NOT within range (i.e. ≥ 20 and ≤ 200 ohms)

  5. Patient has a device generator battery voltage at elective replacement interval (ERI)

  6. Patient has another existing active implanted medical device (e.g. neurostimulator,infusion pump, etc.) that has MR labeling that will not allow the MRI scans to becompleted.

  7. Patient has other non-MRI compatible device or material implanted NOTE:

  • MRI compatible knee replacements, hip replacements, stents, etc. may be includedas long as the labeling of these devices allow MRI scans conducted per thisprotocol

  • MRI compatible mechanical, prosthetic, and bioprosthetic heart valves may beincluded as long as the labeling of these devices allow for MRI scans conductedper this protocol

  • Non-removable dental implants may be included

  1. Patient has a lead extender, adaptor, or capped/abandoned lead

  2. Patient is pregnant

Study Design

Total Participants: 189
Study Start date:
June 01, 2016
Estimated Completion Date:
January 31, 2018

Study Description

This study will be performed as part of a regulated, prospective, non-randomized, multi-center clinical study.

Subjects will be enrolled, undergo a clinically-indicated MRI scan, and have an assessment of adverse events, device measurements, and clinical utility of the MRI scan images.

Connect with a study center

  • Scottsdale Medical Imaging

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • University of Arizona

    Tucson, Arizona 85719
    United States

    Site Not Available

  • St. Bernards

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • Quest Imaging

    Bakersfield, California 93311
    United States

    Site Not Available

  • Raymond Schaerf, MD

    Burbank, California 91505
    United States

    Site Not Available

  • John Muir Medical Center

    Concord, California 94520
    United States

    Site Not Available

  • St. Helena Hospital

    Deer Park, California 94576
    United States

    Site Not Available

  • Cardiovascular Consultants Heart Center

    Fresno, California 93720
    United States

    Site Not Available

  • Newport Diagnostic Center

    Newport Beach, California 92660
    United States

    Site Not Available

  • Pro Health Advance Imaging

    North Hollywood, California 91602
    United States

    Site Not Available

  • Eisenhower Medical Center

    Rancho Mirage, California 92270
    United States

    Site Not Available

  • St. Mary's Medical Center

    San Francisco, California 94117
    United States

    Site Not Available

  • Sansum Clinic - Santa Barbara Medical Foundation

    Santa Barbara, California 93105
    United States

    Site Not Available

  • South Denver Cardiology Associates PC

    Littleton, Colorado 80120
    United States

    Site Not Available

  • Medical Center of the Rockies

    Loveland, Colorado 80538
    United States

    Site Not Available

  • Hartford Hospital

    Hartford, Connecticut 06102
    United States

    Site Not Available

  • Christiana Hospital

    Newark, Delaware 19718
    United States

    Site Not Available

  • Cardiac Arrhythmia Services

    Boca Raton, Florida 33422
    United States

    Site Not Available

  • Jupiter Medical Center

    Jupiter, Florida 33458
    United States

    Site Not Available

  • Florida Hospital

    Orlando, Florida 32803
    United States

    Site Not Available

  • Piedmont Athens Regional Medical Center

    Athens, Georgia 30606
    United States

    Site Not Available

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois 60068
    United States

    Site Not Available

  • Prairie Education and Research Cooperative

    Springfield, Illinois 62701
    United States

    Site Not Available

  • Community Heart and Vascular

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Kansas University Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • King's Daughters Medical Center

    Ashland, Kentucky 25704
    United States

    Site Not Available

  • LSU Health Sciences Center

    Shreveport, Louisiana 71130
    United States

    Site Not Available

  • Suburban Hospital

    Bethesda, Maryland 20814
    United States

    Site Not Available

  • Washington Adventist Hospital

    Takoma Park, Maryland 20912
    United States

    Site Not Available

  • McLaren Health Care Corporation

    Auburn Hills, Michigan 48326
    United States

    Site Not Available

  • Baptist Medical Center

    Jackson, Mississippi 39202
    United States

    Site Not Available

  • Advanced Radiology

    Colombia, Missouri 65201
    United States

    Site Not Available

  • Advanced Radiology

    Columbia, Missouri 65201
    United States

    Site Not Available

  • St. Luke's Hospital

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Mercy Hospital St. Louis

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Kearney Regional Medical Center

    Kearney, Nebraska 68845
    United States

    Site Not Available

  • Denville Diagnostics and Open MRI LLC

    Denville, New Jersey 07834
    United States

    Site Not Available

  • Borg and Ide Imaging

    Rochester, New York 14618
    United States

    Site Not Available

  • St. Francis Hospital

    Roslyn, New York 11576
    United States

    Site Not Available

  • Novant Clinical Research Institute

    Winston Salem, North Carolina 27103
    United States

    Site Not Available

  • Novant Clinical Research Institute

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • The Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Samaritan Heart & Vascular Institute - Cardiology Dept.

    Corvallis, Oregon 97330
    United States

    Site Not Available

  • Oregon Medical Group

    Eugene, Oregon 97401
    United States

    Site Not Available

  • Providence St. Vincent Medical Center

    Portland, Oregon 97225
    United States

    Site Not Available

  • Lehigh Valley Hospital - 17th Street

    Allentown, Pennsylvania 19118
    United States

    Site Not Available

  • Geisinger Medical Center

    Danville, Pennsylvania 17822-2150
    United States

    Site Not Available

  • St. Mary Medical Center

    Langhorne, Pennsylvania 19047
    United States

    Site Not Available

  • Allegheny Singer Research Institute

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Allegheny Singer Research Institute

    Pittsburgh,, Pennsylvania 15212
    United States

    Site Not Available

  • Donald Guthrie Foundation for Education and Research

    Sayre, Pennsylvania 18840
    United States

    Site Not Available

  • Trident Medical Center

    Charleston, South Carolina 29406
    United States

    Site Not Available

  • Erlanger Medical Center

    Chattanooga, Tennessee 37403
    United States

    Site Not Available

  • Baylor All Saints Medical Center at Fort Worth

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • East Texas Medical Center

    Tyler, Texas 75701
    United States

    Site Not Available

  • Lynchburg General Hospital

    Lynchburg, Virginia 24501
    United States

    Site Not Available

  • Sentara Norfolk General Hospital

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Overlake Hospital Medical Center

    Bellevue, Washington 98004
    United States

    Site Not Available

  • Swedish Medical Center - Heart & Vascular

    Seattle, Washington 98122
    United States

    Site Not Available

  • Aurora Medical Group

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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