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

This study is ongoing, but not recruiting participants.
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: July 10, 2014
Last verified: March 2014
  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:


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.
  Show Detailed Description

  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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00907361

Locations
United States, California
Providence St. Joseph Medical Center
Burbank, California, United States, 91505
Scripps Clinic/Green Hospital
La Jolla, California, United States, 92037
Scripps Memorial Hospital
La Jolla, California, United States, 92037
UCLA Cardiac Arrhythmia Center
Los Angeles, California, United States, 90095
Spectrum Clinical Research
Moreno Valley, California, United States, 92553
University of California, San Diego
San Diego, California, United States, 92103
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
United States, Florida
Aventura Hospital and Medical Center
Aventura, Florida, United States, 33180
United States, Indiana
Northern Indiana Research Alliance
Fort Wayne, Indiana, United States, 46804
United States, Kentucky
Baptist Health Lexington
Lexington, Kentucky, United States, 40503
United States, Michigan
Providence Heart Institute
Southfield, Michigan, United States, 48075
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, New Jersey
The Valley Hospital
Ridgewood, New Jersey, United States, 07450
United States, New York
Advanced Cardiovascular Imaging
New York, New York, United States, 10128
United States, Oklahoma
Oklahoma Heart Research and Education Foundation
Tulsa, Oklahoma, United States, 74133
United States, Pennsylvania
Abington Health System
Abington, Pennsylvania, United States, 19001
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84157
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
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: July 10, 2014
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 August 20, 2014