ST Monitoring to Detect Acute Coronary Syndrome Events in Implantable Cardioverter Defibrillator Patients

Last updated: January 8, 2021
Sponsor: Abbott Medical Devices
Overall Status: Terminated

Phase

N/A

Condition

Chest Pain

Coronary Artery Disease

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT01424722
CRD_420
  • Ages > 18
  • All Genders

Study Summary

This is a prospective, non-randomized, multicenter, pivotal Investigational Device Exemption (IDE) study. The intent of this study is to demonstrate the safety and effectiveness of the ST Monitoring Feature in St Jude Medical ICD systems.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eligible patients will meet all of the following:
  1. Have an indication for an ICD implantation or pulse generator change
  2. Have documented coronary artery disease. Documented coronary artery disease isdefined as having at least one of the following present a) evidence of a prior MIon ECG and/or cardiac enzymes, b) prior revascularization (by coronary arterybypass grafting or percutaneous coronary intervention) c) angina and/or ST-T waveabnormalities indicative of ischemia on exercise stress test, nuclear stresstest, or echo stress test, or d) coronary artery disease diagnosed by coronaryangiography.
  3. Willing and able to comply with protocol requirements, including keeping allrequired visits
  4. Willing to participate in the study and able to sign an IRB approved informedconsent form
  5. Be at least 18 years of age when enrolled in the study

Exclusion

Exclusion Criteria:

  • Patients will be excluded if they meet any of the following:
  1. Are pacemaker dependent (defined as a need for ventricular pacing ≥ 20% of thetime)
  2. Have NYHA Class IV Heart Failure
  3. Have persistent or permanent atrial fibrillation
  4. Have a known history of intermittent Bundle Branch Block
  5. Pregnant or planning a pregnancy during the study participation
  6. Have a life expectancy of < 1 year due to any condition
  7. Are currently participating in a clinical investigation that includes an activetreatment arm.

Study Design

Total Participants: 2258
Study Start date:
August 01, 2011
Estimated Completion Date:
June 30, 2017

Study Description

This is a prospective, non-randomized, multicenter, pivotal IDE study. The intent of this study is to demonstrate the safety and effectiveness of the ST Monitoring Feature in the Fortify® ST, Fortify Assura® ST, and Ellipse® ST family of devices, as well as any future St Jude Medical devices with the same ST Monitoring Feature capabilities. Effectiveness of the device will be evaluated by analyzing the sensitivity of the ST Monitoring Feature to detect clinical events. In addition, safety of the ST Monitoring Feature will be evaluated by demonstrating a low percentage of patients with false positive events.

Connect with a study center

  • Cardiovascular Associates PC

    Birmingham, Alabama 35213
    United States

    Site Not Available

  • University Hospital - Univ. of Alabama at Birmingham (UAB)

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Heart Center Research, LLC

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Banner Heart Hospital

    Mesa, Arizona 85206
    United States

    Site Not Available

  • Banner Heart Hospital

    Meza, Arizona 85206
    United States

    Site Not Available

  • Arizona Arrhythmia Research Center

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Carondelet Specialist Group - Southwest Heartr

    Tucson, Arizona 85710
    United States

    Site Not Available

  • Arkansas Cardiology

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Arkansas Heart Hospital

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Central Cardiology

    Bakersfield, California 93308
    United States

    Site Not Available

  • John Muir Medical Center

    Concord, California 94520
    United States

    Site Not Available

  • St. Jude Hospital

    Fullerton, California 92835
    United States

    Site Not Available

  • Cardia Care Specialists

    Glendale, California 91203
    United States

    Site Not Available

  • Glendale Memorial Hospital and Medical Center

    Glendale, California 91204
    United States

    Site Not Available

  • Scripps Memorial Hospital La Jolla

    La Jolla, California 92037
    United States

    Site Not Available

  • Long Beach Memorial

    Long Beach, California 90806
    United States

    Site Not Available

  • Kaiser Permanente Los Angeles

    Los Angeles, California 90027
    United States

    Site Not Available

  • USC University Hospital

    Los Angeles, California 90033
    United States

    Site Not Available

  • Cardiac Rhythm Specialists, Inc.

    Northridge, California 91325
    United States

    Site Not Available

  • Sutter Memorial Hospital

    Sacramento, California 95819
    United States

    Site Not Available

  • Colorado Cardiac Alliance

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Cardiology Associates of Fairfield County

    Norwalk, Connecticut 06851
    United States

    Site Not Available

  • Christiana Hospital

    Newark, Delaware 19718
    United States

    Site Not Available

  • Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Washington Hospital Center

    Washington, D.C., District of Columbia 20010
    United States

    Site Not Available

  • Manatee Memorial Hospital

    Bradenton, Florida 34208
    United States

    Site Not Available

  • Cardiology Consultants PA

    Daytona Beach, Florida 32114
    United States

    Site Not Available

  • Holy Cross Hospital

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • First Coast Cardiovascular Institute

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Watson Clinic Center

    Lakeland, Florida 33805
    United States

    Site Not Available

  • University of Miami Hospital

    Miami, Florida 33136
    United States

    Site Not Available

  • Munroe Regional Medical Center

    Ocala, Florida 34471
    United States

    Site Not Available

  • Florida Hospital Orlando

    Orlando, Florida 32803
    United States

    Site Not Available

  • Athens Regional Medical Center

    Athens, Georgia 30606
    United States

    Site Not Available

  • Northeast Georgia Heart Center, PC

    Gainesville, Georgia 30501
    United States

    Site Not Available

  • Redmond Regional Medical Center

    Rome, Georgia 30165
    United States

    Site Not Available

  • The Queen's Medical Center

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • The Queen&apos;s Medical Center

    Honolusu, Hawaii 96813
    United States

    Site Not Available

  • Northwestern Memorial Hospital

    Chicago, Illinois 60565
    United States

    Site Not Available

  • Northern Indiana Research Alliance

    Fort Wayne, Indiana 46804
    United States

    Site Not Available

  • Iowa Heart Center

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Mid-America Cardiology Associates, PC

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Kentucky Heart Institute / King's Daughter

    Ashland, Kentucky 41101
    United States

    Site Not Available

  • Central Baptist Hospital

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Heart Clinic of Hammond

    Hammond, Louisiana 70403
    United States

    Site Not Available

  • Ochsner Medical Center

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • MedStar Research Institute

    Baltimore, Maryland 21237
    United States

    Site Not Available

  • Shady Grove Adventist Hospital

    Rockville, Maryland 20850
    United States

    Site Not Available

  • University of Massachusettts Medical Center

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • Thoracic Cardiovascular Healthcare Foundation

    Lansing, Michigan 48910
    United States

    Site Not Available

  • Providence Hospital

    Southfield, Michigan 48075
    United States

    Site Not Available

  • Munson Medical Center

    Traverse City, Michigan 49684
    United States

    Site Not Available

  • VA Medical Center Minneapolis

    Minneapolis, Minnesota 55417
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Jackson Heart Clinic

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • North Kansas City Hospital

    North Kansas City, Missouri 64116
    United States

    Site Not Available

  • Mercy Hospital St. Louis

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Mercy Medical Research Institute

    Springfield, Missouri 65804
    United States

    Site Not Available

  • Mercy Hospital St. Louis

    St. Louis, Missouri 63141
    United States

    Site Not Available

  • Deborah Heart and Lung Center

    Browns Mills, New Jersey 08015
    United States

    Site Not Available

  • Lourdes Cardiology Services

    Cherry Hill, New Jersey 08034
    United States

    Site Not Available

  • Englewood Hospital & Medical Center

    Englewood, New Jersey 07631
    United States

    Site Not Available

  • Cardiovascular Associates of the Delaware Valley

    Haddon Heights, New Jersey 08035
    United States

    Site Not Available

  • New Mexico Heart Institute

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Southwest Heart PC

    Las Cruces, New Mexico 88011
    United States

    Site Not Available

  • Buffalo Heart Group

    Buffalo, New York 14215
    United States

    Site Not Available

  • Stony Brook Medical Center

    Stony Brook, New York 11794
    United States

    Site Not Available

  • LeBauer Cardiovascular Research Foundation

    Greensboro, North Carolina 27401
    United States

    Site Not Available

  • Forsyth Medical Center

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Northeast Ohio Cardiovascular Associates

    Akron, Ohio 44304
    United States

    Site Not Available

  • The Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • University Hospitals of Cleveland

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Ohio Health Research Institute

    Columbus, Ohio 43214
    United States

    Site Not Available

  • Ohio State Univeristy

    Columbus, Ohio 43210
    United States

    Site Not Available

  • EMH Regional Medical Center

    Elyria, Ohio 44035
    United States

    Site Not Available

  • University of Toledo Medical Center

    Toledo, Ohio 43614
    United States

    Site Not Available

  • Oklahoma Heart Institute at Utica

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Capital Cardiovascular Associates

    Camp Hill, Pennsylvania 17011
    United States

    Site Not Available

  • Penn State Milton Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Allegheny-Singer Research Institute

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Donald Guthrie Foundation for Education and Research

    Sayre, Pennsylvania 18840
    United States

    Site Not Available

  • Columbia Cardiology Consultants

    Columbia, South Carolina 29204
    United States

    Site Not Available

  • Upstate Cardiology

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Cardiology Consultants

    Johnson City, Tennessee 37601
    United States

    Site Not Available

  • Methodist University Hospital

    Memphis, Tennessee 38104
    United States

    Site Not Available

  • St. Thomas Hospital Heart

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • Vanderbilt Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Cardiology Center of Amarillo, LLP

    Amarillo, Texas 73106
    United States

    Site Not Available

  • Heartplace North Arlington

    Arlington, Texas 76012
    United States

    Site Not Available

  • VA Medical Center Dallas

    Dallas, Texas 75216
    United States

    Site Not Available

  • South Texas Cardiovascular Consultants

    San Antonio, Texas 78201
    United States

    Site Not Available

  • Scott & White Memorial Hospital

    Temple, Texas 76508
    United States

    Site Not Available

  • Cardiovascular Associates of East Texas

    Tyler, Texas 75701
    United States

    Site Not Available

  • McKay-Dee Heart Services

    Ogden, Utah 84403
    United States

    Site Not Available

  • Sentara Norfolk General Hospital

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Hunter Holmes McGuire VAMC

    Richmond, Virginia 23249
    United States

    Site Not Available

  • The Hope Heart Institute

    Bellevue, Washington 98004
    United States

    Site Not Available

  • The Heart Institute at Virginia Mason

    Seattle, Washington 98101
    United States

    Site Not Available

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