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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Tachycardia, Ventricular, Heart Failure, Congestive, Ventricular Fibrillation, Ventricular Dysfunction, Bradycardia

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Overall<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implanted Systems Frequencies | Frequencies of implanted systems were measured among patients who were implanted with a device (IPT, ICD or CRT-D). | Baseline | 
| 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. | Baseline | 
| 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. | Baseline | 
| 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. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months post enrollment | 
| AV Block Status by Severity of Historical AV Block | Frequencies of Subjects with AV Block Over Time by Severity of Historical AV Block | 4 years post implant | 
| Summary of ATP Episodes Within All Treated Episodes | Evaluate the utility of the Antitachycardia Pacing (ATP) During Charging feature of the device. | 4 years post enrollment | 
| 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. | 4 years post implant | 
| 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: The NYHA classification number increases (example: I to II), or The LVEF decreases by at least 20% (relative difference) and by at least a 5% absolute difference, or The subject expires A subject who crossed OptiVol threshold since last visit was regarded as 'crossed threshold'. | 4 years post implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pacemaker, Defibrillator, Cardiac Resynchronization, Dysynchrony, Heart failure, Arrhythmia, Tachycardia, Bradycardia