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

Stopped early

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

In brief

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.

Key facts

Study ID

NCT00277524

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

3032

Starts

2005-08-01

Expected to finish

2010-11-01

Last updated by the study team

2013-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Arkansas Cardiology PA (Little Rock AR) — Little Rock, Arkansas, United States
• California Heart Medical Associates — Fresno, California, United States
• Apex Cardiology — Inglewood, California, United States
• Scripps Green Hospital Scripps Clinic Torrey Pines — La Jolla, California, United States
• Northern California Heart Care — Larkspur, California, United States
• Mission Internal Medical Group — Mission Viejo, California, United States
• Orange County Heart Institute & Research Center — Orange, California, United States
• Foothill Cardiology — Pasadena, California, United States
• Desert Cardiology Center / Desert Cardiology Medical Group Consultants — Rancho Mirage, California, United States
• Brett Berman Cardiology & Cardiac Electrophysiology — San Diego, California, United States
• Dwain L Coggins MD FACC — San Jose, California, United States
• Cardiology Clinic of San Antonio — Tarzana, California, United States
• Erol Kosar MD Inc — Torrance, California, United States
• Rocky Mountain Cardiology PC — Boulder, Colorado, United States
• Pikes Peak Cardiology — Colorado Springs, Colorado, United States
• Daytona Heart — Daytona Beach, Florida, United States
• Florida Arrhythmia Consultants — Fort Lauderdale, Florida, United States
• Clark & Daughtrey Medical Group PA — Lakeland, Florida, United States
• Melbourne Internal Medicine Associates / Century Research Associates — Melbourne, Florida, United States
• C. Raghavan MD PA — Orlando, Florida, United States
• Northwest Florida Heart Group PA — Pensacola, Florida, United States
• Heart & Vascular Institute of Florida — Safety Harbor, Florida, United States
• Florida Cardiovascular Institute PA — Tampa, Florida, United States
• Interventional Cardiac Consultants PLC — Trinity, Florida, United States
• Southern Arizona Health Care System — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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