Enlighten Study: The EV-ICD Post Approval Registry

Active, not recruiting

• Conditions: Tachycardia; Ventricular Arrhythmia

• Registration Number: NCT06048731
• Lead Sponsor: Medtronic

Brief 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.

Study Timeline

• Study First Submitted: 2023-08-30
• Study Start: 2023-09-01
• Study First Submitted QC: 2023-09-20
• Study First Posted: 2023-09-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-07-28
• Last Update Posted: 2025-07-30
• Primary Completion: 2030-05-31
• Study Completion: 2037-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complication-free survival rate	5 years	To demonstrate 5-year Aurora EV-ICD major system-related complication-free survival \> 79%

Secondary Outcome Measures

Name	Time	Method
Summarize ATP with spontaneous arrhythmias	Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)	Summarize ATP with spontaneous arrhythmias
Characterize asystole pacing	Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)	Characterize asystole pacing
Summarize all device system revisions	Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)	Summarize all device system revisions (e.g., reposition, replacement, explant) including reasons for modification and action taken
Patient deaths	Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)	Summarize patient deaths
System and/or procedure related complication-free survival	Procedure related complications assessed during and after the procedure/surgery; system related complications assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)	To estimate the Aurora EV-ICD major system and/or procedure related complication-free survival probability as a function of time post-implant
To characterize defibrillation shock effectiveness for terminating spontaneous VT/VF arrhythmia	Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)	Characterize high voltage therapy effectiveness on device detected spontaneous ventricular episodes
Characterize lead location and lead motion at implant.	Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)	Characterize lead location and lead motion at implant.
Abnormal battery depletion complications	Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)	Characterize the rate of abnormal battery depletion complications as a function of time post-implant
Patient demographics and baseline medical history	Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)	Summarize patient demographics and baseline medical history
Characterize extracardiac pacing sensation	Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)	Characterize extracardiac pacing sensation
Characterize sensing and detection	Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)	Characterize sensing and detection

Trial Locations

Locations (131)

Cardiology Associates Medical Group; 🇺🇸 Huntington Park, California, United States

Sequoia Hospital; 🇺🇸 Redwood City, California, United States

University of California San Diego; 🇺🇸 San Diego, California, United States

Stanford Hospital & Clinics; 🇺🇸 Stanford, California, United States

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

Clearwater Cardiovascular Consultants; 🇺🇸 Clearwater, Florida, United States

Baptist Health; 🇺🇸 Jacksonville, Florida, United States

Cardiovascular Institute of Northwest Florida; 🇺🇸 Panama City, Florida, United States

Intercoastal Medical Group; 🇺🇸 Sarasota, Florida, United States

Wellstar Research Institute; 🇺🇸 Marietta, Georgia, United States

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