SJM MRI Diagnostic Imaging Registry (IDE)

Launched by ABBOTT MEDICAL DEVICES · Jun 17, 2016

Keywords

ClinConnect Summary

This study will be performed as part of a regulated, prospective, non-randomized, multi-center clinical study.

Subjects will be enrolled, undergo a clinically-indicated MRI scan, and have an assessment of adverse events, device measurements, and clinical utility of the MRI scan images.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. Patient's device and all leads must be implanted for at least 6 weeks prior to the scheduled date of the MRI.
• • 3. 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.
• • 4. Patient is scheduled for a non-thoracic MRI scan up to 1.5T.
• • 5. Patient has a pacemaker, ICD, or CRT device implanted pectorally.
• • 6. Patient has the ability to provide informed consent for study participation and be willing and able to comply with the study procedures.
• • 7. Patient is 18 years or above, or of legal age to give informed consent specific to state and national law.
• Exclusion Criteria:
• • 1. Patient has an ICD/CRT-D and is pacemaker dependent
• • 2. Capture threshold is greater than 2.5 volts at 0.5 ms for RA and RV leads
• • 3. Pacing lead impedance is NOT within range (i.e. ≥ 200 and ≤ 2000 ohms)
• • 4. High voltage lead impedance (HVLI) is NOT within range (i.e. ≥ 20 and ≤ 200 ohms)
• • 5. Patient has a device generator battery voltage at elective replacement interval (ERI)
• • 6. 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.
• • 7. 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
• • 8. Patient has a lead extender, adaptor, or capped/abandoned lead
• • 9. Patient is pregnant