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

A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing Magnetic Resonance Imaging, an Investigational Device Exemption (IDE) Study

To demonstrate safety and efficacy of the Durata or Optisure high voltage lead and Ellipse VR ICD in an MRI environment.

The intent of this IDE study is to evaluate the safety and efficacy of the Durata or Optisure lead and Ellipse VR ICD that have undergone an MRI scan. The patient population under study includes patients indicated for or who have been implanted with a Durata or Optisure lead and an Ellipse VR ICD.

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 < 2.5V @ 0.5ms
• Ventricular sensing is measurable (patient has underlying rhythm > 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)