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

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ClinicalTrials.gov Identifier: NCT00277524
Recruitment Status : Terminated (Ended follow-up after four years)
First Posted : January 16, 2006
Results First Posted : August 28, 2013
Last Update Posted : August 28, 2013
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Brief 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.


Condition or disease
Tachycardia, Ventricular Heart Failure, Congestive Ventricular Fibrillation Ventricular Dysfunction Bradycardia

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.

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Study Type : Observational
Actual Enrollment : 3032 participants
Time Perspective: Prospective
Official Title: OMNI Study--Assessing Therapies in Medtronic Pacemaker, Defibrillator, and Cardiac Resynchronization Therapy Devices.
Study Start Date : August 2005
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010


Group/Cohort
Overall
All 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.



Primary Outcome Measures :
  1. Implanted Systems Frequencies [ Time Frame: Baseline ]
    Frequencies of implanted systems were measured among patients who were implanted with a device (IPT, ICD or CRT-D).

  2. Implantable Pulse Generator (IPG) Device Baseline Programming Frequencies. [ Time Frame: Baseline ]
    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.

  3. ICD/CRT-D Device Baseline Programming Frequencies [ Time Frame: Baseline ]
    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.

  4. ICD/CRT-D Device Baseline Programming Measurements [ Time Frame: Baseline ]

    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.



Secondary Outcome Measures :
  1. AV Block Status by Device Type at 6 and 12 Months. [ Time Frame: 12 months post enrollment ]
    Frequencies of subject with AV block over time between ICD and Implantable Pulse Generator(IPG) study participants.

  2. AV Block Status by Severity of Historical AV Block [ Time Frame: 4 years post implant ]
    Frequencies of Subjects with AV Block Over Time by Severity of Historical AV Block

  3. Summary of ATP Episodes Within All Treated Episodes [ Time Frame: 4 years post enrollment ]
    Evaluate the utility of the Antitachycardia Pacing (ATP) During Charging feature of the device.

  4. Compare First Shock Rate Between Medtronic "PainFREE" Programming and "SCD-HeFT" Programming in Primary Prevention Study Participants. [ Time Frame: 4 years post implant ]

    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.


  5. Frequencies of Subjects With OptiVol Trends and Disease Progression. [ Time Frame: 4 years post implant ]

    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'.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00277524


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Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Medtronic
Investigators
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Principal Investigator: Michael O. Sweeney Cardiovascular Division Brigham and Womens

Publications:
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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT00277524     History of Changes
Other Study ID Numbers: 601
First Posted: January 16, 2006    Key Record Dates
Results First Posted: August 28, 2013
Last Update Posted: August 28, 2013
Last Verified: May 2013

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
Pacemaker
Defibrillator
Cardiac Resynchronization
Dysynchrony
Heart failure
Arrhythmia
Tachycardia
Bradycardia

Additional relevant MeSH terms:
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Heart Failure
Tachycardia
Ventricular Dysfunction
Bradycardia
Ventricular Fibrillation
Tachycardia, Ventricular
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes