Enlighten Study: The EV-ICD Post Approval Registry

Medtronic is sponsoring Enlighten: The EV-ICD Post Approval Registry, to further confirm safety and effectiveness of EV-ICD in routine clinical practice, following commercial release of EV-ICD devices.

The Enlighten Study is a global, prospective, observational, multi-site registry study. This study is conducted within Medtronic's post-market surveillance platform. Eligibility for enrollment is based on market release dates for EV-ICD System within the geography in which the subject is enrolled. Patients enrolled in the Enlighten Study will be prospectively followed for the life time of device post-implant or until registry closure, patient death or patient exit from the registry (i.e., withdrawal of consent). Successfully implanted patients are expected to have scheduled follow-up visits per routine clinical care, at least annually, or as prompted by reportable adverse events. The total estimated registry duration is through lifetime of device.

Inclusion Criteria: * Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements * Patient is intended to receive or be treated with a EV-ICD device System and must be enrolled prior to the EV-ICD device implant procedure Exclusion Criteria: * Patient who is, or is expected to be, inaccessible for follow-up * Patient is excluded by local local law * Patient is currently enrolled or plans to enroll in any concurrent drug and/or device study that may confound the PSR results