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

This study has been terminated.
(Ended follow-up after four years)
Sponsor:
Collaborator:
Medtronic
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00277524
First received: January 12, 2006
Last updated: November 15, 2010
Last verified: November 2010
History of Changes
  Purpose

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.


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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: OMNI Study--Assessing Therapies in Medtronic Pacemaker, Defibrillator, and Cardiac Resynchronization Therapy Devices.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • 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 ]

Enrollment: 3032
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)
Groups/Cohorts
Overall
All patients enrolled in OMNI.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients receiving a specified Medtronic Implantable Pulse Generator(IPG), Implantable Cardioverter Defibrillator(ICD), or Cardiac Resynchronization Therapy-Defibrillator(CRT-D) device where informed consent and/or authorization to use and disclose health information permission has been granted.

Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00277524

  Show 115 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Medtronic
Investigators
Principal Investigator: Michael O. Sweeney Cardiovascular Division Brigham and Womens
  More Information

Publications:
Liang KY, Zeger S. Longitudinal data analysis using generalized linear models. Biometrika, 1986, 73:13-22.

Responsible Party: Melinda Hoey, Clinical Research Specialist, Medtronic
ClinicalTrials.gov Identifier: NCT00277524     History of Changes
Other Study ID Numbers: 601
Study First Received: January 12, 2006
Last Updated: November 15, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Pacemaker
Defibrillator
Cardiac Resynchronization
dysynchrony
 Heart failure
Arrhythmia
Tachycardia
Bradycardia

Additional relevant MeSH terms:
Heart Failure
Tachycardia
Ventricular Fibrillation
Tachycardia, Ventricular
Ventricular Dysfunction
 Bradycardia
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013