Enlighten Study: The EV-ICD Post Approval Registry

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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 approximately every 6 months, but at least annually, or as prompted by reportable adverse events. The total estimated registry duration is is through lifetime of device. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06048731
Study type	Observational
Source	Medtronic
Contact	EV-ICD PAS/PMCF Study manager
Phone	18006338766
Email	rs.productsurveillanceregistry@medtronic.com
Status	Recruiting
Phase
Start date	September 1, 2023
Completion date	October 31, 2037

View Details

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