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

Terminated

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

Registration Number: NCT00277524

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 3032

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Implanted Systems Frequencies	Baseline	Frequencies of implanted systems were measured among patients who were implanted with a device (IPT, ICD or CRT-D).
Implantable Pulse Generator (IPG) Device Baseline Programming Frequencies.	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.
ICD/CRT-D Device Baseline Programming Frequencies	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.
ICD/CRT-D Device Baseline Programming Measurements	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

Name	Time	Method
AV Block Status by Device Type at 6 and 12 Months.	12 months post enrollment	Frequencies of subject with AV block over time between ICD and Implantable Pulse Generator(IPG) study participants.
AV Block Status by Severity of Historical AV Block	4 years post implant	Frequencies of Subjects with AV Block Over Time by Severity of Historical AV Block
Summary of ATP Episodes Within All Treated Episodes	4 years post enrollment	Evaluate the utility of the Antitachycardia Pacing (ATP) During Charging feature of the device.
Compare First Shock Rate Between Medtronic "PainFREE" Programming and "SCD-HeFT" Programming in Primary Prevention Study Participants.	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.
Frequencies of Subjects With OptiVol Trends and Disease Progression.	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'.

Trial Locations

Locations (112): Southern Arizona Health Care System
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Tucson, Arizona, United States
Arkansas Cardiology PA (Little Rock AR)
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Little Rock, Arkansas, United States
California Heart Medical Associates
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Fresno, California, United States
Apex Cardiology
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Inglewood, California, United States
Scripps Green Hospital Scripps Clinic Torrey Pines
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La Jolla, California, United States
Northern California Heart Care
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Larkspur, California, United States
Mission Internal Medical Group
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Mission Viejo, California, United States
Orange County Heart Institute & Research Center
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Orange, California, United States
Foothill Cardiology
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Pasadena, California, United States
Desert Cardiology Center / Desert Cardiology Medical Group Consultants
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Rancho Mirage, California, United States
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Southern Arizona Health Care System
🇺🇸Tucson, Arizona, United States