Enlighten Study: The EV-ICD Post Approval Registry

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Tachycardia; Ventricular Arrhythmia
• Intervention / Treatment: Device: Defibrillation using EV-ICD

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
    • LKH - Universitätsklinikum Graz
  • Innsbruck, Austria
    • Aö Landeskrankenhaus - Universitätskliniken Innsbruck
  • Linz, Austria
    • Kepler Universitatsklinikum Med Campus III
  • Wien, Austria
    • Allgemeines Krankenhaus - Universitätskliniken Wien
• Belgium
  • Brugge, Belgium
    • AZ Sint Jan Brugge-Oostende av
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-Luc
• Canada
  • Montreal, Canada
    • McGill University Health Centre (MUHC)
  • Alberta
    • Calgary, Alberta, Canada, T2N2T9
      • University of Calgary
  • Quebec
    • Montréal, Quebec, Canada, H1T1C8
      • Montreal Heart Institute
    • Québec, Quebec, Canada, G1V4G5
      • Institut Universitaire de Cardiologie et de Pneumo
• Czechia
  • Prague, Czechia
    • Nemocnice Na Homolce
• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet
  • Odense, Denmark
    • Odense Universitetshospital
• Finland
  • Helsinki, Finland
    • Helsinki university hospital
• France
  • Clermont Ferrand, France, 63003
    • Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
  • La Tronche, France
    • Centre Hospitalier Universitaire de Grenoble - Site Nord
  • Lille, France, 59037
    • Centre Hospitalier Regional Universitaire de Lille
  • Montpellier, France
    • OC Santé - Clinique du Millénaire
  • Nantes Cedex 1, France, 44093
    • Hôpital Guillaume et René Laënnec - CHU de Nantes
  • Paris, France
    • Institut Mutualiste Montsouris
  • Paris, France
    • Hôpital Européen Georges Pompidou
  • Paris, France
    • Hôpital Pitié-Salpêtrière AP-HP
  • Pessac, France, 33604
    • Hôpital Haut-Lévêque - CHU de Bordeaux
  • Rennes, France
    • CHU de Rennes - Hôpital Pontchaillou
  • Saint-Avertin, France
    • CHRU de Tours - Hopital Trousseau
• Germany
  • Bad Oeynhausen, Germany
    • Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
  • Bremen, Germany, 28277
    • Elektrophysiologie Bremen - Im Klinikum Links der Weser
  • Hanover, Germany
    • Medizinische Hochschule Hannover
  • Stuttgart, Germany
    • Robert-Bosch-Krankenhaus
  • Tübingen, Germany, 72076
    • Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen
• Greece
  • Athens, Greece
    • Hippokration General Hospital of Athens
  • Thessaloníki, Greece
    • George Papanikolaou General Hospital
• Hong Kong
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital
• Hungary
  • Budapest, Hungary
    • Semmelweis Egyetem AOK
• Israel
  • Jerusalem, Israel
    • Shaare Zedek Medical Center
  • Ramat Gan, Israel
    • Sheba Medical Center
• Italy
  • Bari, Italy
    • Azienda Ospedaliera - Universitaria Consorziale Policlinico di Bari
  • Bologna, Italy
    • Policlinico Di Sant Orsola Malpighi
  • Milano, Italy
    • Centro Cardiologico Monzino
  • Milano, Italy, 20162
    • Azienda Ospedaliera Ospedale Niguarda Ca Granda
  • Monza, Italy
    • Azienda Ospedaliera San Gerardo
• Kuwait
  • Kuwait, Kuwait
    • Chest Disease Hospital
• Netherlands
  • Amsterdam, Netherlands
    • Amsterdam UMC - Locatie AMC
  • Den Haag, Netherlands
    • HagaZiekenhuis - Locatie Leyweg
  • Enschede, Netherlands
    • Medisch Spectrum Twente
  • Groningen, Netherlands
    • Universitair Medisch Centrum Groningen
  • Leiden, Netherlands
    • Leids Universitair Medisch Centrum (LUMC)
  • Nieuwegein, Netherlands
    • St Antonius Ziekenhuis
  • Rotterdam, Netherlands
    • Erasmus Medisch Centrum
• New Zealand
  • Christchurch, New Zealand, 8011
    • Christ Church Hospital
• Poland
  • Poznań, Poland, 61-848
    • Uniwersytecki Szpital Kliniczny w Poznaniu
  • Warsaw, Poland, 02-097
    • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
  • Warsaw, Poland, 04-628
    • Narodowy Instytut Kardiologii - Stefana kardynała Wyszyńskiego
  • Zabrze, Poland
    • Slaskie Centrum Chorob Serca
• Portugal
  • Carnaxide, Portugal
    • Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz
  • Lisboa, Portugal
    • Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE
• Saudi Arabia
  • Jeddah, Saudi Arabia, 21159
    • King Fahad Armed Forces Hospital
  • Riyadh, Saudi Arabia
    • King Faisal Specialist Hospital & Research Centre
• Spain
  • Barcelona, Spain
    • Hospital Universitari Bellvitge
  • Coruña, Spain
    • Hospital Universitario da Coruna
  • Córdoba, Spain
    • Hospital Universitario Reina Sofia
  • Girona, Spain
    • Hospital Universitari de Girona Doctor Josep Trueta
  • Granada, Spain
    • Hospital Universitario Virgen de Las Nieves
  • Palma De Mallorca, Spain
    • Hospital Universitario Son Espases
  • Valencia, Spain
    • Hospital Universitario y Politecnico La Fe
• Sweden
  • Göteborg, Sweden
    • Sahlgrenska Universitetssjukhuset
  • Skåne, Sweden
    • Skanes Universitetssjukhus
• Switzerland
  • Basel, Switzerland, 4031
    • Universitätsspital Basel
  • Bern, Switzerland
    • INSELSPITAL - Universitätsspital Bern
  • Lausanne, Switzerland
    • Centre hospitalier universitaire vaudois
  • Lugano, Switzerland
    • Istituto Cardiocentro Ticino
  • Zurich, Switzerland
    • Universitätsspital Zürich
• United Kingdom
  • Leicester, United Kingdom
    • Glenfield Hospital
  • London, United Kingdom
    • Kings College Hospital NHS Foundation Trust
• United States
  • California
    • Huntington Park, California, United States, 93003
      • Cardiology Associates Medical Group
    • Redwood City, California, United States, 94062
      • Sequoia Hospital
    • San Diego, California, United States, 92093
      • University of California San Diego
    • Stanford, California, United States, 94305
      • Stanford Hospital & Clinics
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
  • Florida
    • Clearwater, Florida, United States, 33756
      • Clearwater Cardiovascular Consultants
    • Jacksonville, Florida, United States, 32207
      • Baptist Health
    • Panama City, Florida, United States, 32405
      • Cardiovascular Institute of Northwest Florida
    • Sarasota, Florida, United States, 34232
      • Intercoastal Medical Group
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Wellstar Research Institute
  • Indiana
    • Newburgh, Indiana, United States, 47630
      • Deaconess Specialty Physicians
  • Iowa
    • West Des Moines, Iowa, United States, 50266-8209
      • Iowa Heart Center
  • Kentucky
    • Louisville, Kentucky, United States, 40205
      • Norton Heart and Vascular Institute
  • Maryland
    • Salisbury, Maryland, United States, 21801
      • TidalHealth Peninsula Regional
  • Massachusetts
    • Boston, Massachusetts, United States, 02114-2621
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02115
      • Brigham and Woman's Hospital
  • Michigan
    • Lansing, Michigan, United States, 48912
      • Sparrow Clinical Research Institute
    • Ypsilanti, Michigan, United States, 48197
      • Michigan Heart
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Metropolitan Cardiology Consultants
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute Foundation
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Medical Center Fairview
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Health System
    • Kansas City, Missouri, United States, 66160
      • University of Kansas Medical Center Research Institute
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Virtua Health
    • Morristown, New Jersey, United States, 07962
      • Atlantic Health System
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Presbyterian Heart Group
  • New York
    • Bay Shore, New York, United States, 11706
      • Northwell Health South Shore University Hospital
    • Huntington, New York, United States, 11743
      • Northwell Health Huntington Hospital
    • Manhasset, New York, United States, 11030
      • Northwell Health North Shore University Hospital
    • New Hyde Park, New York, United States, 11040
      • Long Island Jewish Medical Center
    • New York, New York, United States, 10065
      • New York - Presbyterian Hospital / Weill Cornell Medical Center
    • New York, New York, United States, 10016-4972
      • NYU Langone Medical Center
    • New York, New York, United States, 10032
      • New York-Presbyterian Hospital Columbia University
    • Poughkeepsie, New York, United States, 12601
      • Hudson Valley Heart Center
    • Staten Island, New York, United States, 10305
      • Northwell Health Staten Island University Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center (DUMC)
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital Health Network CRD
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center
    • Columbus, Ohio, United States, 43214
      • OhioHealth Research Institute (OHRI)
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18018
      • Saint Luke's University Health Network
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Pittsburg, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center UPMC Presbyterian
    • Pittsburg, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center UPMC Shadyside
    • Pittsburgh, Pennsylvania, United States, 15237
      • University of Pittsburgh Medical Center UPMC Passavant
    • Wilkes-Barre, Pennsylvania, United States, 18711
      • Geisinger Wyoming Valley Medical Center
  • Tennessee
    • Memphis, Tennessee, United States, 38138
      • The Stern Cardiovascular Foundation
    • Nashville, Tennessee, United States, 37203
      • Saint Thomas Research Institute
    • Nashville, Tennessee, United States, 337232-8802
      • Vanderbilt University Medical Center
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia Research Foundation
    • Dallas, Texas, United States, 75226
      • Consultants in Cardiology (Fort Worth)
    • Fort Worth, Texas, United States, 76104
      • Heart Center of North Texas
    • Plano, Texas, United States, 75093
      • Baylor Research Institute
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Cardiovascular Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication-free survival rate	To demonstrate 5-year Aurora EV-ICD major system-related complication-free survival > 79%	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abnormal battery depletion complications	Characterize the rate of abnormal battery depletion complications as a function of time post-implant	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	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	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	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	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	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	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	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	Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 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	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)
Characterize lead location and lead motion at implant.	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)

Collaborators and Investigators

• Sponsor: Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): October 31, 2037

Study Registration Dates

• First Submitted: August 30, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Tachycardia
• Other Study ID Numbers: PSR: EV-ICD PAS/PMCF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• product manufactured in and exported from the U.S.: No