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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) (MagnaSafe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00907361
Recruitment Status : Completed
First Posted : May 22, 2009
Last Update Posted : November 23, 2015
Sponsor:
Collaborators:
Scripps Clinic
Abbott Medical Devices
Boston Scientific Corporation
Biotronik, Inc.
Information provided by (Responsible Party):
Scripps Health

Brief 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.

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

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Study Type : Observational
Actual Enrollment : 2039 participants
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
Study Start Date : April 2009
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine



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.


Primary Outcome Measures :
  1. Rate of device failure. [ Time Frame: Anytime during follow up ]

Secondary Outcome Measures :
  1. Rate of device parameter changes [ Time Frame: Anytime during follow up ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00907361


Locations
Show Show 21 study locations
Sponsors and Collaborators
Scripps Health
Scripps Clinic
Abbott Medical Devices
Boston Scientific Corporation
Biotronik, Inc.
Investigators
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Principal Investigator: Robert J Russo, MD, PhD Scripps Clinic

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Scripps Health
ClinicalTrials.gov Identifier: NCT00907361    
Other Study ID Numbers: MagnaSafe-095151
First Posted: May 22, 2009    Key Record Dates
Last Update Posted: November 23, 2015
Last Verified: November 2015
Keywords provided by Scripps Health:
pacemaker
ICD
Implantable Cardioverter Defibrillator
MRI
Magnetic Resonance Imaging