Status:
TERMINATED
OMNI Study--Assessing Therapies in Medtronic Pacemaker, Defibrillator, and Cardiac Resynchronization Therapy Devices.
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Collaborating Sponsors:
Medtronic
Conditions:
Tachycardia, Ventricular
Heart Failure, Congestive
Eligibility:
All Genders
18+ years
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)therap...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
3032 Patients enrolled
Trial Details
Trial ID
NCT00277524
Start Date
August 1 2005
End Date
November 1 2010
Last Update
August 28 2013
Active Locations (113)
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1
Southern Arizona Health Care System
Tucson, Arizona, United States, 85712-2836
2
Arkansas Cardiology PA (Little Rock AR)
Little Rock, Arkansas, United States, 72205-6231
3
California Heart Medical Associates
Fresno, California, United States, 93720
4
Apex Cardiology
Inglewood, California, United States, 90301-4057