SJM MRI Diagnostic Imaging Registry (IDE)
MRI Imaging Study
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
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.
Primary disease category: Heart/Cardiovascular
Sponsor: St. Jude Medical
Projected enrollment dates: January 2017 to January 2019
Official study title: SJM MRI Diagnostic Imaging Registry“A Clinical Evaluation of the Diagnostic Utility of MRI scans in patients implanted with St. Jude Medical pacemakers, ICDs, and CRTs”