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

NCT00277524 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 3032

Last updated 2013-08-28

Study results available
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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.

Conditions

  • Tachycardia, Ventricular
  • Heart Failure, Congestive
  • Ventricular Fibrillation
  • Ventricular Dysfunction
  • Bradycardia

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Michael O. Sweeney · Cardiovascular Division Brigham and Womens

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00277524 on ClinicalTrials.gov