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

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.

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.

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.

Time frame: Baseline

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

Time frame: Baseline

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

Time frame: 12 months post enrollment

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

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.

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'.

Time frame: 4 years post implant

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

Time frame: 4 years post enrollment