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

This study is currently recruiting participants.
Verified August 2012 by Scripps Health
Sponsor:
Collaborators:
The Scripps Foundation
The Hewitt Medical Research Foundation
St. Jude Medical
Boston Scientific Corporation
Biotronik, Inc.
Information provided by (Responsible Party):
Scripps Health
ClinicalTrials.gov Identifier:
NCT00907361
First received: May 20, 2009
Last updated: May 16, 2013
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Need for MRI Imaging With Pacemaker or
Implantable Cardioverter Defibrillator Implanted
 Device: MRI with pacemaker or ICD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The MagnaSafe Registry: Determining the Risks of MRI in the Presence of Pacemakers and Implantable Cardioverter Defibrillators

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Scripps Health:

Primary Outcome Measures:
  • Rate of device failure. [ Time Frame: Anytime during follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of device parameter changes [ Time Frame: Anytime during follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: April 2009
Intervention Details:
    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.
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  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

Adult patient with pacemaker or ICD that is scheduled for a clinically indicated MRI.

Criteria

Inclusion Criteria:

  • Male or female 18 years or older
  • Able to provide informed consent
  • Permanent implanted pacemaker or ICD
  • Strong clinical indication for MRI; in the clinical setting where MRI is the diagnostic modality of choice for a specific disease state without acceptable alternative imaging technology as determined by the ordering physician.
  • Patient is scheduled for non-thoracic MRI (joint, extremity, brain, pelvis, cervical, and lumbar or sacral spine)

Exclusion Criteria:

  • Metallic objects that represent a contraindication to MR imaging, including: intra-orbital or intra-ocular retained metal fragments, and intracranial vascular clips and coils
  • Claustrophobia unresponsive to pre-procedure sedatives
  • Morbid obesity (abdominal diameter >60 cm)
  • ICD or pacemaker generator placement prior to 2002
  • ICD and pacing dependent
  • Pregnancy
  • Device generator battery voltage at elective replacement index (ERI)
  • Presence of active implantable medical device (other than pacemaker or ICD)
  • Presence of abandoned leads (with the exception of post CABG temporary epicardial pacing wires)
  • Presence of implanted cardiac device in the abdominal position
  • Pacemaker or ICD that is labeled as MRI-Conditional (approved by the FDA for exposure to MRI).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907361

Contacts
Contact: Heather S. Costa, PhD, MPH 858-554-5273 costa.heather@scrippshealth.org

  Show 21 Study Locations
Sponsors and Collaborators
Scripps Health
The Scripps Foundation
The Hewitt Medical Research Foundation
St. Jude Medical
Boston Scientific Corporation
Biotronik, Inc.
Investigators
Principal Investigator: Robert J Russo, MD, PhD Scripps Clinic
  More Information

No publications provided

Responsible Party: Scripps Health
ClinicalTrials.gov Identifier: NCT00907361     History of Changes
Other Study ID Numbers: MagnaSafe-095151
Study First Received: May 20, 2009
Last Updated: May 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Scripps Health:
pacemaker
ICD
Implantable Cardioverter Defibrillator
MRI
Magnetic Resonance Imaging

ClinicalTrials.gov processed this record on May 23, 2013