A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing MRI, an IDE Study

Inclusion Criteria

• Are implanted with the Durata or Optisure lead for at least 60 days (can include patients with Durata or Optisure lead for > 60 days OR patients with a new Ellipse VR ICD and/or Durata/Optisure lead implanted for at least 60 days
• Are implanted with an Ellipse VR ICD pectorally
• Be 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
• Capture threshold is stable 30bpm) and the sensing amplitude is > 4mV
• Be able to provide informed consent for study participation (legal guardian or legally authorized representative is NOT acceptable)
• Be willing and able to comply with the prescribed follow-up tests and procedures
• Are not contraindicated for an MRI scan (per the MRI Screening Form)

Exclusion Criteria

• Have a competitor's MRI compatible endocardial lead implanted or capped
• Have 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.
• Have a lead revision of the Durata/Optisure lead occur < 60 days of the baseline visit
• Have 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
• Have a lead extender, adaptor, or capped/abandoned lead
• 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.
• Pregnant or planning to become pregnant during the duration of the subject's participation in the study
• Have a life expectancy of less than 12 months due to any condition
• Patients with exclusion criteria required by local law (e.g., age)