Status:
COMPLETED
The MagnaSafe Registry: Determining the Risks of Magnetic Resonance Imaging (MRI) in the Presence of Pacemakers and Implantable Cardioverter Defibrillators (ICDs)
Lead Sponsor:
Scripps Health
Collaborating Sponsors:
Scripps Clinic
Abbott Medical Devices
Conditions:
Need for MRI Imaging With Pacemaker or
Implantable Cardioverter Defibrillator Implanted
Eligibility:
All Genders
18+ years
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 ...
Detailed Description
The MagnaSafe Registry is an investigator initiated study designed to determine the risks of performing MRI for patients with pacemakers and Implantable Cardioverter-Defibrillators (ICDs). We hope tha...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
2039 Patients enrolled
Trial Details
Trial ID
NCT00907361
Start Date
April 1 2009
End Date
June 1 2014
Last Update
November 23 2015
Active Locations (21)
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1
Providence St. Joseph Medical Center
Burbank, California, United States, 91505
2
Scripps Clinic/Green Hospital
La Jolla, California, United States, 92037
3
Scripps Memorial Hospital
La Jolla, California, United States, 92037
4
UCLA Cardiac Arrhythmia Center
Los Angeles, California, United States, 90095