Enlighten Study: the EV-ICD Post Approval Registry

Medtronic

Status: Active, not recruiting

Conditions: Tachycardia; Ventricular Arrhythmia

Treatments: Device: Defibrillation using EV-ICD

Study type: Observational

Funder types: Industry

Identifiers

NCT06048731

PSR: EV-ICD PAS/PMCF

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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