SJM MRI Diagnostic Imaging Registry (IDE)

Completed · Not applicable

Conditions studied: Cardiac Arrhythmia

In brief

This study is a prospective, non-randomized, multi-center study of subjects implanted with an SJM pacemakers, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices who are clinically indicated for a non-thoracic MRI scan.

Key facts

Study ID

NCT02807948

Run by

Abbott Medical Devices

People needed

189

Starts

2016-06-01

Expected to finish

2018-01-31

Last updated by the study team

2019-08-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is implanted with a market-released St. Jude Medical pacemaker, ICD, or CRT current generation device listed in the study protocol and any market-released pacing or defibrillation lead.
• Patient's device and all leads must be implanted for at least 6 weeks prior to the scheduled date of the MRI.
• Patient has a clinical indication for a non-thoracic MRI scan, where MRI is the imaging modality of choice that will give adequate results to manage the patient.
• Patient is scheduled for a non-thoracic MRI scan up to 1.5T.
• Patient has a pacemaker, ICD, or CRT device implanted pectorally.
• Patient has the ability to provide informed consent for study participation and be willing and able to comply with the study procedures.
• Patient is 18 years or above, or of legal age to give informed consent specific to state and national law.

You may not qualify if…

• Patient has an ICD/CRT-D and is pacemaker dependent
• Capture threshold is greater than 2.5 volts at 0.5 ms for RA and RV leads
• Pacing lead impedance is NOT within range (i.e. ≥ 200 and ≤ 2000 ohms)
• High voltage lead impedance (HVLI) is NOT within range (i.e. ≥ 20 and ≤ 200 ohms)
• Patient has a device generator battery voltage at elective replacement interval (ERI)
• Patient has another existing active implanted medical device (e.g. neurostimulator, infusion pump, etc.) that has MR labeling that will not allow the MRI scans to be completed.
• Patient has other non-MRI compatible device or material implanted
• NOTE:
• MRI compatible knee replacements, hip replacements, stents, etc. may be included as long as the labeling of these devices allow MRI scans conducted per this protocol
• MRI compatible mechanical, prosthetic, and bioprosthetic heart valves may be included as long as the labeling of these devices allow for MRI scans conducted per this protocol
• Non-removable dental implants may be included
• Patient has a lead extender, adaptor, or capped/abandoned lead
• Patient is pregnant

Where it is running

• University of Arizona — Tucson, Arizona, United States
• St. Bernards — Jonesboro, Arkansas, United States
• Quest Imaging — Bakersfield, California, United States
• Raymond Schaerf, MD — Burbank, California, United States
• John Muir Medical Center — Concord, California, United States
• St. Helena Hospital — Deer Park, California, United States
• Cardiovascular Consultants Heart Center — Fresno, California, United States
• Newport Diagnostic Center — Newport Beach, California, United States
• Pro Health Advance Imaging — North Hollywood, California, United States
• Eisenhower Medical Center — Rancho Mirage, California, United States
• St. Mary's Medical Center — San Francisco, California, United States
• Sansum Clinic - Santa Barbara Medical Foundation — Santa Barbara, California, United States
• South Denver Cardiology Associates PC — Littleton, Colorado, United States
• Medical Center of the Rockies — Loveland, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Christiana Hospital — Newark, Delaware, United States
• Cardiac Arrhythmia Services — Boca Raton, Florida, United States
• Jupiter Medical Center — Jupiter, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• Piedmont Athens Regional Medical Center — Athens, Georgia, United States
• Advocate Lutheran General Hospital — Park Ridge, Illinois, United States
• Prairie Education and Research Cooperative — Springfield, Illinois, United States
• Community Heart and Vascular — Indianapolis, Indiana, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• Scottsdale Medical Imaging — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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