Enlighten Study: The EV-ICD Post Approval Registry

NCT06048731 · tracked via the Priya Life Science UK tracker

Sponsor

Medtronic

Phase

Observational

Started

2023-09-01

Last updated

2025-07-30

Condition(s) studied

Ventricular ArrhythmiaTachycardia

Investigational drug(s) / intervention(s)

Defibrillation using EV-ICD

Defibrillation using EV-ICD: Device: Defibrillation using the Extravascular ICD (EV-ICD)

Study 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.

Eligibility

Sex

ALL

Min age

—

Max age

—

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

Primary outcome measure(s)

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

Trial sites (131)

Facility	City	Region
Cardiology Associates Medical Group	Huntington Park	California
Sequoia Hospital	Redwood City	California
University of California San Diego	San Diego	California
Stanford Hospital & Clinics	Stanford	California
Hartford Hospital	Hartford	Connecticut
Clearwater Cardiovascular Consultants	Clearwater	Florida
Baptist Health	Jacksonville	Florida
Cardiovascular Institute of Northwest Florida	Panama City	Florida
Intercoastal Medical Group	Sarasota	Florida
Wellstar Research Institute	Marietta	Georgia
Deaconess Specialty Physicians	Newburgh	Indiana
Iowa Heart Center	West Des Moines	Iowa
Norton Heart and Vascular Institute	Louisville	Kentucky
TidalHealth Peninsula Regional	Salisbury	Maryland
Massachusetts General Hospital	Boston	Massachusetts
Brigham and Woman's Hospital	Boston	Massachusetts
Sparrow Clinical Research Institute	Lansing	Michigan
Michigan Heart	Ypsilanti	Michigan
Metropolitan Cardiology Consultants	Coon Rapids	Minnesota
Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
University of Minnesota Medical Center Fairview	Minneapolis	Minnesota
Mayo Clinic	Rochester	Minnesota
Saint Luke's Health System	Kansas City	Missouri
University of Kansas Medical Center Research Institute	Kansas City	Missouri
Washington University School of Medicine	St Louis	Missouri
Virtua Health	Marlton	New Jersey
Atlantic Health System	Morristown	New Jersey
Presbyterian Heart Group	Albuquerque	New Mexico
Northwell Health South Shore University Hospital	Bay Shore	New York
Northwell Health Huntington Hospital	Huntington	New York
Northwell Health North Shore University Hospital	Manhasset	New York
Long Island Jewish Medical Center	New Hyde Park	New York
NYU Langone Medical Center	New York	New York
New York-Presbyterian Hospital Columbia University	New York	New York
New York - Presbyterian Hospital / Weill Cornell Medical Center	New York	New York
Hudson Valley Heart Center	Poughkeepsie	New York
Northwell Health Staten Island University Hospital	Staten Island	New York
Duke University Medical Center (DUMC)	Durham	North Carolina
The Christ Hospital Health Network CRD	Cincinnati	Ohio
Cleveland Clinic	Cleveland	Ohio

+ 91 more sites — see the full list on the official registry below.

More Medtronic trials in the UK

Micra Transcatheter Pacing System Post-Approval Registry Active, not recruiting

Personalized Therapy Study - HFRS (TriageHF) Post Approval Study Active, not recruiting

Lead Evaluation for Defibrillation and Reliability Post Approval Study Enrolling by invitation

Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products Recruiting

Product Surveillance Registry Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06048731 on ClinicalTrials.gov ↗ ← All trials in the UK