The MagnaSafe Registry: Determining the Risks of Magnetic Resonance Imaging (MRI) in the Presence of Pacemakers and Implantable Cardioverter Defibrillators (ICDs)

NCT00907361 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2039

Last updated 2015-11-23

No results posted yet for this study

Summary

This study will create a registry of patients with pacemakers and implantable ICDs who will undergo clinically indicated MRI and will document the incidence of any adverse events or changes in device parameters that might be associated with the procedure.

Conditions

  • Need for MRI Imaging With Pacemaker or
  • Implantable Cardioverter Defibrillator Implanted

Interventions

DEVICE

MRI with pacemaker or ICD

The aim of the present protocol is to prospectively determine the adverse event rate of non-thoracic MRI for patients with implanted cardiac devices by collecting pre- and post-MRI device interrogations in a multi-center registry.

Sponsors & Collaborators

  • Scripps Clinic

    collaborator OTHER
  • Abbott Medical Devices

    collaborator INDUSTRY
  • Boston Scientific Corporation

    collaborator INDUSTRY
  • Biotronik, Inc.

    collaborator INDUSTRY
  • Scripps Health

    lead OTHER

Principal Investigators

  • Robert J Russo, MD, PhD · Scripps Clinic

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2014-06-30
Completion
2014-06-30

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 NCT00907361 on ClinicalTrials.gov