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The MagnaSafe Registry

Robert J. Russo, MD, PhD. La Jolla, CA. The MagnaSafe Registry: Determining the Risks of MRI in the Presence of Pacemakers and Implantable Cardioverter Defibrillators. The MagnaSafe Registry is a prospective multi-center study designed to determine the risk of non-thoracic 1.5T MRI scanning for patients with implanted cardiac devices. Caution: INVESTIGATIONAL DEVICE EXEMPTION LIMITED BY FEDERAL LAW TO INVESTIGATIONAL USE.

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The MagnaSafe Registry | magnasafe.org Reviews
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Robert J. Russo, MD, PhD. La Jolla, CA. The MagnaSafe Registry: Determining the Risks of MRI in the Presence of Pacemakers and Implantable Cardioverter Defibrillators. The MagnaSafe Registry is a prospective multi-center study designed to determine the risk of non-thoracic 1.5T MRI scanning for patients with implanted cardiac devices. Caution: INVESTIGATIONAL DEVICE EXEMPTION LIMITED BY FEDERAL LAW TO INVESTIGATIONAL USE.
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The MagnaSafe Registry | magnasafe.org Reviews

https://magnasafe.org

Robert J. Russo, MD, PhD. La Jolla, CA. The MagnaSafe Registry: Determining the Risks of MRI in the Presence of Pacemakers and Implantable Cardioverter Defibrillators. The MagnaSafe Registry is a prospective multi-center study designed to determine the risk of non-thoracic 1.5T MRI scanning for patients with implanted cardiac devices. Caution: INVESTIGATIONAL DEVICE EXEMPTION LIMITED BY FEDERAL LAW TO INVESTIGATIONAL USE.

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1

The MagnaSafe Registry

http://www.magnasafe.org/summaryandabstracts.html

One page description with inclusion / exclusion. Presented at ACC 2012. Presented at HRS 2012. Presented at AHA 2012. Presented at the American College of Cardiology. Presented at Heart Rhythm Society. Presented at American Heart Assocation.

2

The MagnaSafe Registry

http://www.magnasafe.org/home.html

Robert J. Russo, MD, PhD. La Jolla, CA. The MagnaSafe Registry: Determining the Risks of MRI in the Presence of Pacemakers and Implantable Cardioverter Defibrillators. The MagnaSafe Registry is a prospective multi-center study designed to determine the risk of non-thoracic 1.5T MRI scanning for patients with implanted cardiac devices. Caution: INVESTIGATIONAL DEVICE EXEMPTION LIMITED BY FEDERAL LAW TO INVESTIGATIONAL USE.

3

The MagnaSafe Registry

http://www.magnasafe.org/protocolsummary.html

A cardiologist or other qualified physician with appropriate training and experience. In pacemaker/ICD function will supervise the study. ACLS trained personnel and a crash cart, including a non-MRI compatible defibrillator and transcutaneous pacemaker, will be available throughout the procedure to respond to an adverse clinical event. All patients will undergo device interrogation in the MRI suite, but outside of the magnet room, immediately prior to and following the scan. All patients will be monitore...

4

The MagnaSafe Registry

http://www.magnasafe.org/sitequalifications.html

Those wishing to participate in the registry as independent investigational site will be required to obtain approval of the FDA-authorized protocol from their reviewing IRB, and complete a written investigator agreement. In addition, sites will be selected for participation in the registry based on:. Experienced clinical/academic centers with expertise in MR imaging and electrophysiology. Sufficient MRI volume to. Enroll 25-50 cases in a one-year period. Alternatively, if you are unable to participate as...

5

The MagnaSafe Registry

http://www.magnasafe.org/aboutmagnasafe.html

Registry is a prospective multi-center study designed to determine the risks of performing non-thoracic 1.5T MRI scanning for patients with implanted. Pacemakers and Implantable Cardioverter-Defibrillators (ICDs). We will determine the rates of temporary and permanent device parameter changes, including changes in lead threshold, lead impedance and battery voltage. Patients with pacemakers or ICDs scheduled for a clinically-indicated MRI will be invited to enroll in the study. Patients will have their de...

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The MagnaSafe Registry

Robert J. Russo, MD, PhD. La Jolla, CA. The MagnaSafe Registry: Determining the Risks of MRI in the Presence of Pacemakers and Implantable Cardioverter Defibrillators. The MagnaSafe Registry is a prospective multi-center study designed to determine the risk of non-thoracic 1.5T MRI scanning for patients with implanted cardiac devices. Caution: INVESTIGATIONAL DEVICE EXEMPTION LIMITED BY FEDERAL LAW TO INVESTIGATIONAL USE.

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