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Tachycardia, VentricularOMNINCT00277524

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

An observational study of Tachycardia, Ventricular and Heart Failure, Congestive, run by Medtronic Cardiac Rhythm and Heart Failure at 113 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
3,032 participants
Where
113 sitesUnited States
Study dates
Aug 2005to Nov 2010
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients receiving a specified Medtronic Implantable Pulse Generator(IPG), Implantable Cardioverter Defibrillator(ICD), or Cardiac Resynchronization Therapy-Defibrillator(CRT-D) device where informed consent and/or authorization to use and disclose health information permission has been granted.

Who may be able to join

  • Implant of new or replacement study device. Enrollment must occur no later than 40 days post-implant.
  • Study participants must be 18 years of age or older.

Who cannot join

  • Study participants enrolled or intend to participate in another clinical device trial during the course of this study that required specific treatment or programming.
  • Study participants unwilling and unable to comply with follow-up schedule.

Trial locations and contacts

113 sites in 1 country.

113 sites in 1 country

United States113 sites

  • Albany Associates in Cardiology

    Albany, New York, 12205-1438

  • Altoona Regional Health Center

    Altoona, Pennsylvania, 16601-4804

  • Amarillo Heart Group

    Amarillo, Texas, 79106-2430

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

    Ann Arbor, Michigan, 48105-2303

  • Cardiology Associates PC

    Annapolis, Maryland, 21401

  • King's Daughters Medical Center

    Ashland, Kentucky, 41101-2843

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Bluestem Cardiology PC

    Bartlesville, Oklahoma, 74006

  • Cardio Research of New York Inc

    Bayside, New York, 11361

  • Midwest Cardiology PC

    Belleville, Illinois, 62226

  • Rocky Mountain Cardiology PC

    Boulder, Colorado, 80304

  • Cardiovascular Consultants (Cape Giradeau MO)

    Cape Girardeau, Missouri, 63703

  • Cardiologists PC

    Cedar Rapids, Iowa, 52403

  • CAMC Institute Clinical Trials Center

    Charleston, West Virginia, 25304

  • Sanger Heart and Vascular Institute-Charlotte

    Charlotte, North Carolina, 28203

  • TriHealth Good Samaritan Hos

    Cincinnati, Ohio, 45220-2475

  • Pikes Peak Cardiology

    Colorado Springs, Colorado, 80909

  • Columbia Heart Clinic PA

    Columbia, South Carolina, 29203

  • Cardiovascular Associates LLC

    Covington, Louisiana, 70433

  • Dallas VA Medical Center

    Dallas, Texas, 75216

  • Daytona Heart

    Daytona Beach, Florida, 32114

  • New Jersey Heart (Elizabeth NJ)

    Elizabeth, New Jersey, 07202

  • Cardiovascular Associates

    Elk Grove Village, Illinois, 60007

  • EMH Elyria Medical Center

    Elyria, Ohio, 44035

  • Englewood Hospital & Medical Center

    Englewood, New Jersey, 07631

  • The Heart Group PC

    Evansville, Indiana, 47710-1656

  • Internal Medicine & Cardiology Associates of Southeastern New England PC

    Fall River, Massachusetts, 02720

  • Pee Dee Cardiology

    Florence, South Carolina, 29506

  • Florida Arrhythmia Consultants

    Fort Lauderdale, Florida, 33308

  • Cardiovascular Specialists of Frederick

    Frederick, Maryland, 21702

  • California Heart Medical Associates

    Fresno, California, 93720

  • Heart Care Inc

    Gahanna, Ohio, 43230

  • Northeast Georgia Heart Center PC

    Gainesville, Georgia, 30501

  • The Heart Center

    Glen Burnie, Maryland, 21061-5613

  • Genesys Regional Medical Center

    Grand Blanc, Michigan, 48439

  • Altru Hospital

    Grand Forks, North Dakota, 58201-4032

  • Heart Rhythm Associates PLLC

    Greenville, North Carolina, 27834

  • Piedmont Cardiology Associates (Greenwood SC)

    Greenwood, South Carolina, 29646

  • Hattiesburg Clinic/Forrest General

    Hattiesburg, Mississippi, 39401

  • High Point Regional Health System

    High Point, North Carolina, 27262

  • Saint Mary Medical Center (Community Healthcare System)

    Hobart, Indiana, 46342

  • Edward N Shen MD Inc

    Honolulu, Hawaii, 96813

  • Hall Garcia Cardiology Associates

    Houston, Texas, 77030-2309

  • Apex Cardiology

    Inglewood, California, 90301-4057

  • Borgess Medical Center

    Kalamazoo, Michigan, 49048

  • Scripps Green Hospital Scripps Clinic Torrey Pines

    La Jolla, California, 92037-1027

  • Clark & Daughtrey Medical Group PA

    Lakeland, Florida, 33803

  • Cardiology Consultants of East Michigan

    Lapeer, Michigan, 48446

  • Northern California Heart Care

    Larkspur, California, 94939

  • Arkansas Cardiology PA (Little Rock AR)

    Little Rock, Arkansas, 72205-6231

  • University Medical Associates

    Louisville, Kentucky, 40202-1901

  • Macon Electrophysiology Associates PC

    Macon, Georgia, 31201

  • Wisconsin Heart SC

    Madison, Wisconsin, 53713-2319

  • Stark Medical Specialties Inc

    Massillon, Ohio, 44646

  • Heart Clinic PLLC

    McAllen, Texas, 78503

  • Melbourne Internal Medicine Associates / Century Research Associates

    Melbourne, Florida, 32901

  • Memphis Heart Clinic

    Memphis, Tennessee, 38120

  • Heart Consultants

    Midwest City, Oklahoma, 73110

  • University of Minnesota

    Minneapolis, Minnesota, 55455-0368

  • Mission Internal Medical Group

    Mission Viejo, California, 92691-6384

  • James H Quillen VA Medical Center

    Mountain Home, Tennessee, 37604

  • New Bedford Medical Associates

    New Bedford, Massachusetts, 02740

  • New York Medical Center of Queens

    New York, New York, 10001

  • Heartwise Cardiology

    New York, New York, 10016

  • Arrhythmia Associates of New York

    New York, New York, 10028-1802

  • Arrhythmia Institute

    Newtown, Pennsylvania, 18940-1885

  • Medical Center Hospital Odessa

    Odessa, Texas, 76761

  • Utah Cardiology (Ogden UT)

    Ogden, Utah, 84405-7420

  • Terrance Khastgir MD PC

    Oklahoma City, Oklahoma, 73112-4457

  • Heart Consultants PC

    Omaha, Nebraska, 68122

  • Orange County Heart Institute & Research Center

    Orange, California, 92868

  • C. Raghavan MD PA

    Orlando, Florida, 32819

  • Foothill Cardiology

    Pasadena, California, 91105

  • Saint Joseph's Regional Medical Center

    Paterson, New Jersey, 07503

  • Northwest Florida Heart Group PA

    Pensacola, Florida, 32514

  • Cardiology Consultants of Philadelphia

    Philadelphia, Pennsylvania, 19107

  • Pacific Heart Associates

    Portland, Oregon, 97227

  • Marshall-Rismiller & Associates

    Pottsville, Pennsylvania, 17901

  • Wake Heart & Vascular Associates

    Raleigh, North Carolina, 27610-1231

  • Desert Cardiology Center / Desert Cardiology Medical Group Consultants

    Rancho Mirage, California, 92270

  • Baltimore Heart Associates (Randallstown MD)

    Randallstown, Maryland, 21133-4707

  • Reno Heart Physicians

    Reno, Nevada, 89503-4541

  • Virginia Cardiovascular Specialists PC

    Richmond, Virginia, 23226-1928

  • Mayo Clinic

    Rochester, Minnesota, 55905-0001

  • University Cardiovascular Associates (UCVA)

    Rochester, New York, 14618-2663

  • Shady Grove Adventist Hospital

    Rockville, Maryland, 20850

  • Heart & Vascular Institute of Florida

    Safety Harbor, Florida, 34695-6604

  • Great Lakes Heart and Vascular Institute PC

    Saint Joseph, Michigan, 49085

  • Saint Paul Cardiology

    Saint Paul, Minnesota, 55102-1036

  • North Shore Cardiology Associates

    Salem, Massachusetts, 01970

  • Peninsula Cardiology Associates

    Salisbury, Maryland, 21804

  • Cardiology Clinic of San Antonio

    San Antonio, Texas, 78229

  • Brett Berman Cardiology & Cardiac Electrophysiology

    San Diego, California, 92103

  • Dwain L Coggins MD FACC

    San Jose, California, 95124

  • Cardiovascular Consultants (Savannah GA)

    Savannah, Georgia, 31404

  • Cardiology Associates of Schenectady PC

    Schenectady, New York, 12304

  • Saint Catherine of Sienna Medical Center

    Smithtown, New York, 11787-1628

  • Cardiovascular Clinical Associates PC

    Southfield, Michigan, 48034

  • Ohio Institute of Cardiac Care Inc

    Springfield, Ohio, 45504

  • Cardiology Consultants of Saint Louis County PC

    St Louis, Missouri, 63128

  • Saint Louis Heart & Vascular PC

    St Louis, Missouri, 63136-6111

  • Florida Cardiovascular Institute PA

    Tampa, Florida, 33609

  • Cardiology Clinic of San Antonio

    Tarzana, California, 91356

  • The Toledo Clinic

    Toledo, Ohio, 43623-4231

  • Erol Kosar MD Inc

    Torrance, California, 90503

  • Interventional Cardiac Consultants PLC

    Trinity, Florida, 34655

  • Southern Arizona Health Care System

    Tucson, Arizona, 85712-2836

  • Cardiovascular Associates of East Texas PA

    Tyler, Texas, 75701

  • Arrhythmia Consultants of Milwaukee SC

    Wauwatosa, Wisconsin, 53226-4362

  • Wilmington Cardiology LLC

    Wilmington, North Carolina, 28403-5345

  • Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

  • Cardiology Associates

    Woodland Park, New Jersey, 07424

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655-0002

Other trials in United States

About this study

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.

Read the detailed 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.

Keywords
Pacemaker, Defibrillator, Cardiac Resynchronization, Dysynchrony, Heart failure, Arrhythmia, Tachycardia, Bradycardia
Medical subject headings
Tachycardia, Ventricular, Heart Failure, Ventricular Fibrillation, Ventricular Dysfunction, Bradycardia, Arrhythmias, Cardiac, Tachycardia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00277524
Study groupRoleWhat they receive
OverallAll patients enrolled in OMNI. Patient sub-groups include device type, history of atrial fibrillation (AF), history of investigate atrioventricular (AV) block, implant indication, and managed ventricular pacing (MVP) enabled.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Implanted Systems Frequencies

    Frequencies of implanted systems were measured among patients who were implanted with a device (IPT, ICD or CRT-D).

    Measured: Baseline

  2. Implantable Pulse Generator (IPG) Device Baseline Programming Frequencies.

    Pacing mode is based on the NASPE/BPEG Generic (NBG) Pacemake coding which includes: I, the chambers paced (V= Ventricle, A=Atrium, D=Dual (A\&V), O=None); II, the chambers sensed (V= Ventricle, A=Atrium, D=Dual (A\&V), O=None); III, the mode of response (T=Triggered, I=Inhibited, D=Dual Triggered/Inhibited, O=None); IV, the programmable functions(R=Rate Modulated, C=Communicating, M=Multiprogrammable, P=Simple Programmable, O=None); V, the antitachycardia functions (O=None, P=Paced, S=Shocks, D=Dual (P\&S)). In addition, MVP (managed ventricular pacing) is a mode that promotes AV conduction by reducing or eliminating unnecessary RV pacing but maintains dual chamber ventricular support in the event that AV conduction is lost.

    Measured: Baseline

  3. ICD/CRT-D Device Baseline Programming Frequencies

    ICD/CRT-D baseline programming, pacing mode and detection. Pacing mode is based on the NASPE/BPEG Generic (NBG) Pacemake coding which includes: I, the chambers paced (V= Ventricle, A=Atrium, D=Dual (A\&V), O=None); II, the chambers sensed (V= Ventricle, A=Atrium, D=Dual (A\&V), O=None); III, the mode of response (T=Triggered, I=Inhibited, D=Dual Triggered/Inhibited, O=None); IV, the programmable functions(R=Rate Modulated, C=Communicating, M=Multiprogrammable, P=Simple Programmable, O=None); V, the antitachycardia functions (O=None, P=Paced, S=Shocks, D=Dual (P\&S)). In addition, MVP (managed ventricular pacing) is a mode that promotes AV conduction by reducing or eliminating unnecessary RV pacing but maintains dual chamber ventricular support in the event that AV conduction is lost.

    Measured: Baseline

  4. ICD/CRT-D Device Baseline Programming Measurements

    ICD/CRT-D baseline programming measurements, detection interval. Implanted Cardioverter/Defibrillator paces a patient's heart in a tachyarrhythmia prevention-pacing mode.

    Detection intervals are used to detect atrial tachyarrhythmia. Detection Intervals are programmable heart rate thresholds. R-R intervals that are less than the VT or VF detection intervals (in ms) are considered evidence of VT or VF, respectively. R-R intervals that are between the FVT and the VF detection intervals are considered evidence of FVT. Thus, these detection interval thresholds demarcate rate zones of detection. The rate zones are used to determine the type of therapy applied once detection occurs.

    Measured: Baseline

Secondary outcomes (5)

  1. AV Block Status by Device Type at 6 and 12 Months.

    Frequencies of subject with AV block over time between ICD and Implantable Pulse Generator(IPG) study participants.

    Measured: 12 months post enrollment

  2. AV Block Status by Severity of Historical AV Block

    Frequencies of Subjects with AV Block Over Time by Severity of Historical AV Block

    Measured: 4 years post implant

  3. Summary of ATP Episodes Within All Treated Episodes

    Evaluate the utility of the Antitachycardia Pacing (ATP) During Charging feature of the device.

    Measured: 4 years post enrollment

  4. Compare First Shock Rate Between Medtronic "PainFREE" Programming and "SCD-HeFT" Programming in Primary Prevention Study Participants.

    First shock rate for VF and FVT zones was estimated using Kaplan-Meier method.

    OMNI "PainFREE" definition: programming combinations that result in ATP therapy for ventricular tachycardia (VT) at cycle lengths <320 ms. Programming at cycle lengths ≥320 ms were not mandated.

    OMNI "SCD-HeFT" definition: programming combinations that result in shock therapy only for arrhythmias at cycle lengths of <320 ms or faster and no therapy for arrhythmias at cycle lengths ≥320 ms.

    Measured: 4 years post implant

  5. Frequencies of Subjects With OptiVol Trends and Disease Progression.

    Estimate the correlation between OptiVol trends and disease progression.

    A subject's disease status was said to have progressed if:

    1. The NYHA classification number increases (example: I to II), or
    2. The LVEF decreases by at least 20% (relative difference) and by at least a 5% absolute difference, or
    3. The subject expires

    A subject who crossed OptiVol threshold since last visit was regarded as 'crossed threshold'.

    Measured: 4 years post implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2006 (estimated)
  2. Study startAug 2005
  3. Primary completionNov 2010
  4. Study completionNov 2010

Why it stopped: Ended follow-up after four years

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
3,032 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00277524
Sponsor's protocol ID
601
Acronym
OMNI
Status last verified
May 2013
First submitted
12 Jan 2006
Last updated
28 Aug 2013
Data monitoring committee
No

Publications

  • Wathen MS, DeGroot PJ, Sweeney MO, Stark AJ, Otterness MF, Adkisson WO, Canby RC, Khalighi K, Machado C, Rubenstein DS, Volosin KJ; PainFREE Rx II Investigators. Prospective randomized multicenter trial of empirical antitachycardia pacing versus shocks for spontaneous rapid ventricular tachycardia in patients with implantable cardioverter-defibrillators: Pacing Fast Ventricular Tachycardia Reduces Shock Therapies (PainFREE Rx II) trial results. Circulation. 2004 Oct 26;110(17):2591-6. doi: 10.1161/01.CIR.0000145610.64014.E4. Epub 2004 Oct 18.

    PubMed 15492306

  • Alpert JS. Are data from clinical registries of any value? Eur Heart J. 2000 Sep;21(17):1399-401. doi: 10.1053/euhj.2000.2265. No abstract available.

    PubMed 10952831

  • Lamas GA, Williams A. Have the results of randomized clinical trials of pacing altered the practice of cardiac pacing? J Cardiovasc Electrophysiol. 2003 Sep;14(9 Suppl):S15-9. doi: 10.1046/j.1540-8167.14.s9.14.x.

    PubMed 12950512

  • Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, Domanski M, Troutman C, Anderson J, Johnson G, McNulty SE, Clapp-Channing N, Davidson-Ray LD, Fraulo ES, Fishbein DP, Luceri RM, Ip JH; Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005 Jan 20;352(3):225-37. doi: 10.1056/NEJMoa043399.

    PubMed 15659722

  • Liang KY, Zeger S. Longitudinal data analysis using generalized linear models. Biometrika, 1986, 73:13-22.

Questions about this trial

What is this clinical trial studying?

An observational study of Tachycardia, Ventricular and Heart Failure, Congestive, run by Medtronic Cardiac Rhythm and Heart Failure at 113 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 113 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implanted Systems Frequencies (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00277524, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2013.

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