OMNI Study--Assessing Therapies in Medtronic Pacemaker, Defibrillator, and Cardiac Resynchronization Therapy Devices.

Last updated: May 21, 2013
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Overall Status: Terminated

Phase

N/A

Condition

Heart Failure

Low Blood Pressure (Hypotension)

Dysrhythmia

Treatment

N/A

Clinical Study ID

NCT00277524
601
  • Ages > 18
  • All Genders

Study Summary

The purpose of the OMNI study is to characterize therapy and diagnostic utilization in study participants implanted with study devices and to describe Implantable Cardioverter Defibrillator(ICD)therapy utilization for life threatening arrhythmias in primary and secondary prevention study participants. This study will assess therapies in Medtronic pacemaker, defibrillator, and cardiac resynchronization therapy devices.

The first therapy is for reducing unnecessary pacing in pacemaker patients. The second therapy provides pacing therapy in an attempt to stop fast or life threatening ventricular arrhythmias in lieu of delivering a defibrillation shock. The third therapy is a diagnostic measurement of a patient's fluid status and provides the physician information on the patient's heart failure status.

The study will also assess the time to a patient's first defibrillation shock and will verify that the shock was for a fast or life threatening ventricular rhythm.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Implant of new or replacement study device. Enrollment must occur no later than 40days post-implant.

  • Study participants must be 18 years of age or older.

Exclusion

Exclusion Criteria:

  • Study participants enrolled or intend to participate in another clinical device trialduring the course of this study that required specific treatment or programming.

  • Study participants unwilling and unable to comply with follow-up schedule.

Study Design

Total Participants: 3032
Study Start date:
August 01, 2005
Estimated Completion Date:
November 30, 2010

Study Description

The OMNI results demonstrate the importance of Medtronic's ongoing efforts to increase adoption of evidence based shock-reduction programming strategies. Longer VF NID (number of intervals to detect in the VF zone) should be utilized with the Anti-tachycardia Pacing (ATP) During Charging Feature. ATP during Charging allows physicians to treat with ATP without delay to shock. Therefore, VF NID may be extended to allow episodes the chance to self-terminate immediately to shock by use of the ATP during the charging feature.

Connect with a study center

  • empty

    Birmingham, Alabama
    United States

    Site Not Available

  • Southern Arizona Health Care System

    Tucson, Arizona 85712-2836
    United States

    Site Not Available

  • Arkansas Cardiology PA (Little Rock AR)

    Little Rock, Arkansas 72205-6231
    United States

    Site Not Available

  • California Heart Medical Associates

    Fresno, California 93720
    United States

    Site Not Available

  • Apex Cardiology

    Inglewood, California 90301-4057
    United States

    Site Not Available

  • Scripps Green Hospital Scripps Clinic Torrey Pines

    La Jolla, California 92037-1027
    United States

    Site Not Available

  • Northern California Heart Care

    Larkspur, California 94939
    United States

    Site Not Available

  • Mission Internal Medical Group

    Mission Viejo, California 92691-6384
    United States

    Site Not Available

  • Orange County Heart Institute & Research Center

    Orange, California 92868
    United States

    Site Not Available

  • Foothill Cardiology

    Pasadena, California 91105
    United States

    Site Not Available

  • Desert Cardiology Center / Desert Cardiology Medical Group Consultants

    Rancho Mirage, California 92270
    United States

    Site Not Available

  • Brett Berman Cardiology & Cardiac Electrophysiology

    San Diego, California 92103
    United States

    Site Not Available

  • Dwain L Coggins MD FACC

    San Jose, California 95124
    United States

    Site Not Available

  • Cardiology Clinic of San Antonio

    Tarzana, California 91356
    United States

    Site Not Available

  • Erol Kosar MD Inc

    Torrance, California 90503
    United States

    Site Not Available

  • Rocky Mountain Cardiology PC

    Boulder, Colorado 80304
    United States

    Site Not Available

  • Pikes Peak Cardiology

    Colorado Springs, Colorado 80909
    United States

    Site Not Available

  • empty

    Washington, District of Columbia
    United States

    Site Not Available

  • Daytona Heart

    Daytona Beach, Florida 32114
    United States

    Site Not Available

  • Florida Arrhythmia Consultants

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Clark & Daughtrey Medical Group PA

    Lakeland, Florida 33803
    United States

    Site Not Available

  • Melbourne Internal Medicine Associates / Century Research Associates

    Melbourne, Florida 32901
    United States

    Site Not Available

  • C. Raghavan MD PA

    Orlando, Florida 32819
    United States

    Site Not Available

  • Northwest Florida Heart Group PA

    Pensacola, Florida 32514
    United States

    Site Not Available

  • empty

    Port St. John, Florida
    United States

    Site Not Available

  • Heart & Vascular Institute of Florida

    Safety Harbor, Florida 34695-6604
    United States

    Site Not Available

  • Florida Cardiovascular Institute PA

    Tampa, Florida 33609
    United States

    Site Not Available

  • Interventional Cardiac Consultants PLC

    Trinity, Florida 34655
    United States

    Site Not Available

  • Emory University Hospital

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Northeast Georgia Heart Center PC

    Gainesville, Georgia 30501
    United States

    Site Not Available

  • Macon Electrophysiology Associates PC

    Macon, Georgia 31201
    United States

    Site Not Available

  • Cardiovascular Consultants (Savannah GA)

    Savannah, Georgia 31404
    United States

    Site Not Available

  • Edward N Shen MD Inc

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • Midwest Cardiology PC

    Belleville, Illinois 62226
    United States

    Site Not Available

  • Cardiovascular Associates

    Elk Grove Village, Illinois 60007
    United States

    Site Not Available

  • The Heart Group PC

    Evansville, Indiana 47710-1656
    United States

    Site Not Available

  • Saint Mary Medical Center (Community Healthcare System)

    Hobart, Indiana 46342
    United States

    Site Not Available

  • Cardiologists PC

    Cedar Rapids, Iowa 52403
    United States

    Site Not Available

  • King's Daughters Medical Center

    Ashland, Kentucky 41101-2843
    United States

    Site Not Available

  • University Medical Associates

    Louisville, Kentucky 40202-1901
    United States

    Site Not Available

  • Cardiovascular Associates LLC

    Covington, Louisiana 70433
    United States

    Site Not Available

  • Cardiology Associates PC

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Cardiovascular Specialists of Frederick

    Frederick, Maryland 21702
    United States

    Site Not Available

  • The Heart Center

    Glen Burnie, Maryland 21061-5613
    United States

    Site Not Available

  • Baltimore Heart Associates (Randallstown MD)

    Randallstown, Maryland 21133-4707
    United States

    Site Not Available

  • Shady Grove Adventist Hospital

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Peninsula Cardiology Associates

    Salisbury, Maryland 21804
    United States

    Site Not Available

  • Internal Medicine & Cardiology Associates of Southeastern New England PC

    Fall River, Massachusetts 02720
    United States

    Site Not Available

  • New Bedford Medical Associates

    New Bedford, Massachusetts 02740
    United States

    Site Not Available

  • North Shore Cardiology Associates

    Salem, Massachusetts 01970
    United States

    Site Not Available

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts 01655-0002
    United States

    Site Not Available

  • University of Michigan Health System (UMHS) VA Medical Center

    Ann Arbor, Michigan 48105-2303
    United States

    Site Not Available

  • Genesys Regional Medical Center

    Grand Blanc, Michigan 48439
    United States

    Site Not Available

  • Borgess Medical Center

    Kalamazoo, Michigan 49048
    United States

    Site Not Available

  • Cardiology Consultants of East Michigan

    Lapeer, Michigan 48446
    United States

    Site Not Available

  • Cardiovascular Clinical Associates PC

    Southfield, Michigan 48034
    United States

    Site Not Available

  • Great Lakes Heart and Vascular Institute PC

    St. Joseph, Michigan 49085
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis, Minnesota 55455-0368
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905-0001
    United States

    Site Not Available

  • Saint Paul Cardiology

    St. Paul, Minnesota 55102-1036
    United States

    Site Not Available

  • Hattiesburg Clinic/Forrest General

    Hattiesburg, Mississippi 39401
    United States

    Site Not Available

  • Cardiovascular Consultants (Cape Giradeau MO)

    Cape Girardeau, Missouri 63703
    United States

    Site Not Available

  • Saint Louis Heart & Vascular PC

    Saint Louis, Missouri 63136-6111
    United States

    Site Not Available

  • Cardiology Consultants of Saint Louis County PC

    St. Louis, Missouri 63128
    United States

    Site Not Available

  • Heart Consultants PC

    Omaha, Nebraska 68122
    United States

    Site Not Available

  • Reno Heart Physicians

    Reno, Nevada 89503-4541
    United States

    Site Not Available

  • New Jersey Heart (Elizabeth NJ)

    Elizabeth, New Jersey 07202
    United States

    Site Not Available

  • Englewood Hospital & Medical Center

    Englewood, New Jersey 07631
    United States

    Site Not Available

  • Saint Joseph's Regional Medical Center

    Paterson, New Jersey 07503
    United States

    Site Not Available

  • Cardiology Associates

    West Paterson, New Jersey 07424
    United States

    Site Not Available

  • Albany Associates in Cardiology

    Albany, New York 12205-1438
    United States

    Site Not Available

  • Cardio Research of New York Inc

    Bayside, New York 11361
    United States

    Site Not Available

  • Arrhythmia Associates of New York

    New York, New York 10028-1802
    United States

    Site Not Available

  • Heartwise Cardiology

    New York, New York 10016
    United States

    Site Not Available

  • New York Medical Center of Queens

    New York City, New York 10001
    United States

    Site Not Available

  • empty

    Poughkeepsie, New York
    United States

    Site Not Available

  • University Cardiovascular Associates (UCVA)

    Rochester, New York 14618-2663
    United States

    Site Not Available

  • Cardiology Associates of Schenectady PC

    Schenectady, New York 12304
    United States

    Site Not Available

  • Saint Catherine of Sienna Medical Center

    Smithtown, New York 11787-1628
    United States

    Site Not Available

  • Sanger Heart and Vascular Institute-Charlotte

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Heart Rhythm Associates PLLC

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • High Point Regional Health System

    High Point, North Carolina 27262
    United States

    Site Not Available

  • Wake Heart & Vascular Associates

    Raleigh, North Carolina 27610-1231
    United States

    Site Not Available

  • Wilmington Cardiology LLC

    Wilmington, North Carolina 28403-5345
    United States

    Site Not Available

  • Forsyth Medical Center

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Altru Hospital

    Grand Forks, North Dakota 58201-4032
    United States

    Site Not Available

  • TriHealth Good Samaritan Hos

    Cincinnati, Ohio 45220-2475
    United States

    Site Not Available

  • EMH Elyria Medical Center

    Elyria, Ohio 44035
    United States

    Site Not Available

  • Heart Care Inc

    Gahanna, Ohio 43230
    United States

    Site Not Available

  • Stark Medical Specialties Inc

    Massillon, Ohio 44646
    United States

    Site Not Available

  • Ohio Institute of Cardiac Care Inc

    Springfield, Ohio 45504
    United States

    Site Not Available

  • The Toledo Clinic

    Toledo, Ohio 43623-4231
    United States

    Site Not Available

  • Bluestem Cardiology PC

    Bartlesville, Oklahoma 74006
    United States

    Site Not Available

  • Heart Consultants

    Midwest City, Oklahoma 73110
    United States

    Site Not Available

  • Terrance Khastgir MD PC

    Oklahoma City, Oklahoma 73112-4457
    United States

    Site Not Available

  • Pacific Heart Associates

    Portland, Oregon 97227
    United States

    Site Not Available

  • Altoona Regional Health Center

    Altoona, Pennsylvania 16601-4804
    United States

    Site Not Available

  • Arrhythmia Institute

    Newtown, Pennsylvania 18940-1885
    United States

    Site Not Available

  • empty

    Norristown, Pennsylvania
    United States

    Site Not Available

  • Cardiology Consultants of Philadelphia

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Marshall-Rismiller & Associates

    Pottsville, Pennsylvania 17901
    United States

    Site Not Available

  • Columbia Heart Clinic PA

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • Pee Dee Cardiology

    Florence, South Carolina 29506
    United States

    Site Not Available

  • Piedmont Cardiology Associates (Greenwood SC)

    Greenwood, South Carolina 29646
    United States

    Site Not Available

  • Memphis Heart Clinic

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • James H Quillen VA Medical Center

    Mountain Home, Tennessee 37604
    United States

    Site Not Available

  • Amarillo Heart Group

    Amarillo, Texas 79106-2430
    United States

    Site Not Available

  • Dallas VA Medical Center

    Dallas, Texas 75216
    United States

    Site Not Available

  • Hall Garcia Cardiology Associates

    Houston, Texas 77030-2309
    United States

    Site Not Available

  • Heart Clinic PLLC

    McAllen, Texas 78503
    United States

    Site Not Available

  • Medical Center Hospital Odessa

    Odessa, Texas 76761
    United States

    Site Not Available

  • Cardiology Clinic of San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Cardiovascular Associates of East Texas PA

    Tyler, Texas 75701
    United States

    Site Not Available

  • Utah Cardiology (Ogden UT)

    Ogden, Utah 84405-7420
    United States

    Site Not Available

  • Virginia Cardiovascular Specialists PC

    Richmond, Virginia 23226-1928
    United States

    Site Not Available

  • CAMC Institute Clinical Trials Center

    Charleston, West Virginia 25304
    United States

    Site Not Available

  • Wisconsin Heart SC

    Madison, Wisconsin 53713-2319
    United States

    Site Not Available

  • empty

    Wausau, Wisconsin
    United States

    Site Not Available

  • Arrhythmia Consultants of Milwaukee SC

    Wauwatosa, Wisconsin 53226-4362
    United States

    Site Not Available

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