A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging

This clinical investigation is a prospective, multicenter, Asian study. The study was designed with two (2) parts, however only the 1st part was completed. For the 1st part, patients were enrolled with a SJM MR Conditional ICD System approved for thoracic scan with 1.5 Tesla MRI scanning machines. The 2nd part-meant to enroll patients for thoracic scans with 3 Tesla MRI scanning machines-was not completed.

Inclusion criteria

• Subject is pectorally implanted with St. Jude Medical™ MR Conditional ICD System for at least 60 days
• Subject is willing to undergo an elective MRI scan without sedation NOTE: Antianxiety agents (e.g. minor tranquilizers, etc.) may be used as long as the patient can communicate with site personnel during the MRI scan
• Subject's ventricular bipolar capture threshold is stable < 2.5V @ 0.5ms
• Subject's ventricular sensing is measurable (patient has underlying rhythm > 30bpm) and the sensing amplitude is stable > 4mV
• Subject is able to provide informed consent for study participation (legal guardian or legally authorized representative is NOT acceptable)
• Subject is willing and able to comply with the prescribed follow-up tests and procedures
• Subject is not contraindicated for an MRI scan (per the MRI Screening Form)

Exclusion criteria

• Subject is pacemaker dependent
• Subject has a non SJM MRI compatible endocardial lead implanted or capped
• Subject has another existing active implanted medical device, e.g., neurostimulator, infusion pump, etc. that has MR labeling that will not allow the MRI scans per this protocol to be completed.
• Subject has a high voltage lead revision incidence < 60 days of the enrollment visit
• Subject 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 NOTE: 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 NOTE: Non-removable dental implants may be included
• Subject has a lead extender, adaptor, or capped/abandoned lead
• Subject is enrolled or intend to participate in a clinical drug and/or device study (investigational device, investigational drug, new indication for a device or drug or additional testing beyond standard of care procedures), which could confound the results of this trial as determined by SJM.
• Subject is pregnant or planning to become pregnant during the duration of the subject's participation in the study
• Subject has a life expectancy of less than 12 months due to any condition
• Subject has exclusion criteria required by local law (e.g., age)