An observational study in Ventricular Arrhythmia and Tachycardia, sponsored by Medtronic. Active, not recruiting at 131 sites in 24 countries. Per ClinicalTrials.gov, last updated 2025-07-30.
Sponsored by Medtronic · Observational
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.
623 studies on the registry are indexed under Tachycardia; 81 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 149 across 208 observational studies indexed under Tachycardia.
Browse Tachycardia studies →Medtronic is the lead sponsor of 42 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients intended to be implanted with a EV-ICD system are eligible for enrollment and all patients must be consented prior to implant. Geographies with regulatory approval for the EV-ICD system are eligible to enroll patients (see locations section). All patients enrolled and successfully implanted with an EV-ICD system will be followed for lifetime of device, unless a patient is exited from the registry due to an unavoidable reason such as death, physician discretion, or patient withdrawal of consent. If EV-ICD system is not successfully implanted, patients will be exited from the registry unless a EV-ICD System and/or implant procedure related event is identified, for which the patient will be followed until the event is resolved or no further actions need to be taken.
Exclusion Criteria:
Device: Defibrillation using the Extravascular ICD (EV-ICD)
Complication-free survival rate
To demonstrate 5-year Aurora EV-ICD major system-related complication-free survival \> 79%
Time frame: 5 years
System and/or procedure related complication-free survival
To estimate the Aurora EV-ICD major system and/or procedure related complication-free survival probability as a function of time post-implant
Time frame: 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)
Abnormal battery depletion complications
Characterize the rate of abnormal battery depletion complications as a function of time post-implant
Time frame: 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
Summarize all device system revisions (e.g., reposition, replacement, explant) including reasons for modification and action taken
Time frame: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Patient deaths
Summarize patient deaths
Time frame: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Patient demographics and baseline medical history
Summarize patient demographics and baseline medical history
Time frame: 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 extracardiac pacing sensation
Time frame: 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
Summarize ATP with spontaneous arrhythmias
Time frame: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Characterize asystole pacing
Characterize asystole pacing
Time frame: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Characterize sensing and detection
Characterize sensing and detection
Time frame: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
To characterize defibrillation shock effectiveness for terminating spontaneous VT/VF arrhythmia
Characterize high voltage therapy effectiveness on device detected spontaneous ventricular episodes
Time frame: 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.
Characterize lead location and lead motion at implant.
Time frame: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Showing the first 100 of 131 sites across 24 countries.
Plan to share: No
This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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