OMNI Study--Assessing Therapies in Medtronic Pacemaker, Defibrillator, and Cardiac Resynchronization Therapy Devices.
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.
Heart Failure, Congestive
|Study Design:||Time Perspective: Prospective|
|Official Title:||OMNI Study--Assessing Therapies in Medtronic Pacemaker, Defibrillator, and Cardiac Resynchronization Therapy Devices.|
- Describe the demographic and clinical profiles, implanted systems, and device programming. [ Time Frame: 5 years post enrollment ] [ Designated as safety issue: No ]
- Investigate Atrioventricular(AV) block progression over time between ICD and Implantable Pulse Generator(IPG) study participants and those with and without a history of AV block. [ Time Frame: 5 years post enrollment ] [ Designated as safety issue: No ]
- Evaluate the utility of the Antitachycardia Pacing(ATP) During Charging feature of the device. [ Time Frame: 5 years post enrollment ] [ Designated as safety issue: No ]
- Compare time to first shock between Medtronic PainFREE programming and "SCD-HeFT programming" in primary prevention study participants. [ Time Frame: 5 years post enrollment ] [ Designated as safety issue: No ]
- Estimate the correlation between OptiVol trends and disease progression. [ Time Frame: 5 years post enrollment ] [ Designated as safety issue: No ]
|Study Start Date:||August 2005|
|Estimated Study Completion Date:||November 2010|
|Estimated Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
All patients enrolled in OMNI.
Show 115 Study Locations
|Principal Investigator:||Michael O. Sweeney||Cardiovascular Division Brigham and Womens|