Confirmatory Clinical Trial of the Evera MRI System for Conditionally-safe MRI Access

Inclusion criteria

• Subjects who are indicated for implantation of an ICD at the time of study enrollment.
• Subjects who are able to undergo a pectoral implant.
• Subjects who are receiving an ICD for the first time.
• Subjects who are able and willing to undergo elective MRI scanning without sedation.
• Subjects who are geographically stable and available for follow-up at the study site for the length of the study.
• Subjects who are at least 18 years of age (or older, if required by local law).

Exclusion criteria

• Subjects with a history of significant tricuspid valvular disease .
• Subjects for whom a single dose of 1.0mg dexamethasone sodium phosphate and/or dexamethasone acetate may be contraindicated.
• Subjects who require a legally authorized representative to obtain informed consent.
• Subjects undergoing device upgrades, change-outs, lead extractions, and/or lead or device revisions.
• Subjects with abandoned or capped leads.
• Subjects who require an indicated MRI scan, other than those specifically described in the Evera MRI™ study, before the one-month post-MRI/waiting period follow-up (approximately 4 months post-implant).
• Subjects with a non-MRI compatible device (such as neurostimulators) or material implant (e.g., non-MRI compatible sternal wires, neurostimulators, biostimulators, metals or alloys).
• Subjects with medical conditions that preclude the testing required by the study protocol or limit study participation.
• Subjects who are enrolled or intend to participate in another clinical trial (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during the Evera MRI™ study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.
• Female patient who is pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative pregnancy test within seven (7) days prior to device implant.
• Subjects with exclusion criteria required by local law (e.g., age, breastfeeding).