NCT06048731

Enlighten Study: The EV-ICD Post Approval Registry

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Medtronic · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Ventricular Arrhythmia
• Tachycardia

Interventions

Type	Name	Description
DEVICE	Defibrillation using EV-ICD	Device: Defibrillation using the Extravascular ICD (EV-ICD)

Timeline

• Start date: 2023-09-01
• Primary completion: 2030-05-31
• Completion: 2037-10-31
• First posted: 2023-09-21
• Last updated: 2025-07-30

Locations

131 sites across 24 countries: United States, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Kuwait, Netherlands, New Zealand, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, United Kingdom