Enlighten Study: The EV-ICD Post Approval Registry
1 other identifier
observational
1,000
24 countries
131
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2023
Longer than P75 for all trials
131 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2023
CompletedStudy Start
First participant enrolled
September 1, 2023
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2037
July 30, 2025
February 1, 2025
6.8 years
August 30, 2023
July 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Complication-free survival rate
To demonstrate 5-year Aurora EV-ICD major system-related complication-free survival \> 79%
5 years
Secondary Outcomes (11)
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)
Abnormal battery depletion complications
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
Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
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
Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
- +6 more secondary outcomes
Interventions
Device: Defibrillation using the Extravascular ICD (EV-ICD)
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtroniclead
Study Sites (131)
Cardiology Associates Medical Group
Huntington Park, California, 93003, United States
Sequoia Hospital
Redwood City, California, 94062, United States
University of California San Diego
San Diego, California, 92093, United States
Stanford Hospital & Clinics
Stanford, California, 94305, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Clearwater Cardiovascular Consultants
Clearwater, Florida, 33756, United States
Baptist Health
Jacksonville, Florida, 32207, United States
Cardiovascular Institute of Northwest Florida
Panama City, Florida, 32405, United States
Intercoastal Medical Group
Sarasota, Florida, 34232, United States
Wellstar Research Institute
Marietta, Georgia, 30060, United States
Deaconess Specialty Physicians
Newburgh, Indiana, 47630, United States
Iowa Heart Center
West Des Moines, Iowa, 50266-8209, United States
Norton Heart and Vascular Institute
Louisville, Kentucky, 40205, United States
TidalHealth Peninsula Regional
Salisbury, Maryland, 21801, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114-2621, United States
Brigham and Woman's Hospital
Boston, Massachusetts, 02115, United States
Sparrow Clinical Research Institute
Lansing, Michigan, 48912, United States
Michigan Heart
Ypsilanti, Michigan, 48197, United States
Metropolitan Cardiology Consultants
Coon Rapids, Minnesota, 55433, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Saint Luke's Health System
Kansas City, Missouri, 64111, United States
University of Kansas Medical Center Research Institute
Kansas City, Missouri, 66160, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Virtua Health
Marlton, New Jersey, 08053, United States
Atlantic Health System
Morristown, New Jersey, 07962, United States
Presbyterian Heart Group
Albuquerque, New Mexico, 87106, United States
Northwell Health South Shore University Hospital
Bay Shore, New York, 11706, United States
Northwell Health Huntington Hospital
Huntington, New York, 11743, United States
Northwell Health North Shore University Hospital
Manhasset, New York, 11030, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
NYU Langone Medical Center
New York, New York, 10016-4972, United States
New York-Presbyterian Hospital Columbia University
New York, New York, 10032, United States
New York - Presbyterian Hospital / Weill Cornell Medical Center
New York, New York, 10065, United States
Hudson Valley Heart Center
Poughkeepsie, New York, 12601, United States
Northwell Health Staten Island University Hospital
Staten Island, New York, 10305, United States
Duke University Medical Center (DUMC)
Durham, North Carolina, 27710, United States
The Christ Hospital Health Network CRD
Cincinnati, Ohio, 45219, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
OhioHealth Research Institute (OHRI)
Columbus, Ohio, 43214, United States
Saint Luke's University Health Network
Bethlehem, Pennsylvania, 18018, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213, United States
University of Pittsburgh Medical Center UPMC Shadyside
Pittsburgh, Pennsylvania, 15232, United States
University of Pittsburgh Medical Center UPMC Passavant
Pittsburgh, Pennsylvania, 15237, United States
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711, United States
The Stern Cardiovascular Foundation
Memphis, Tennessee, 38138, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 337232-8802, United States
Saint Thomas Research Institute
Nashville, Tennessee, 37203, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705, United States
Consultants in Cardiology (Fort Worth)
Dallas, Texas, 75226, United States
Heart Center of North Texas
Fort Worth, Texas, 76104, United States
Baylor Research Institute
Plano, Texas, 75093, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908, United States
Aurora Cardiovascular Services
Milwaukee, Wisconsin, 53215, United States
LKH - Universitätsklinikum Graz
Graz, Austria
Aö Landeskrankenhaus - Universitätskliniken Innsbruck
Innsbruck, Austria
Kepler Universitätsklinikum Med Campus III
Linz, Austria
Allgemeines Krankenhaus - Universitätskliniken Wien
Vienna, Austria
AZ Sint Jan Brugge-Oostende av
Bruges, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
University Of Calgary
Calgary, Alberta, T2N2T9, Canada
Montreal Heart Institute
Montreal, Quebec, H1T1C8, Canada
Institut Universitaire de Cardiologie et de Pneumo
Québec, Quebec, G1V4G5, Canada
McGill University Health Centre (MUHC)
Montreal, Canada
Nemocnice Na Homolce
Prague, Czechia
Rigshospitalet
Copenhagen, Denmark
Odense Universitetshospital
Odense, Denmark
Helsinki University Hospital
Helsinki, Finland
Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
Clermont-Ferrand, 63003, France
Centre Hospitalier Universitaire de Grenoble - Site Nord
La Tronche, France
Centre Hospitalier Régional Universitaire de Lille
Lille, 59037, France
OC Santé - Clinique du Millénaire
Montpellier, France
Hôpital Guillaume et René Laënnec - CHU de Nantes
Nantes, 44093, France
Hopital Pitie-Salpetriere AP-HP
Paris, France
Hôpital Européen Georges Pompidou
Paris, France
Institut Mutualiste Montsouris
Paris, France
Hôpital Haut-Lévêque - CHU de Bordeaux
Pessac, 33604, France
CHU de Rennes - Hôpital Pontchaillou
Rennes, France
CHRU de Tours - Hôpital Trousseau
Saint-Avertin, France
Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
Bad Oeynhausen, Germany
Elektrophysiologie Bremen - Im Klinikum Links der Weser
Bremen, 28277, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Robert-Bosch-Krankenhaus
Stuttgart, Germany
Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen
Tübingen, 72076, Germany
Hippokration General Hospital of Athens
Athens, Greece
George Papanikolaou General Hospital
Thessaloniki, Greece
Prince of Wales Hospital
Hong Kong, Hong Kong
Semmelweis Egyetem AOK
Budapest, Hungary
Shaare Zedek Medical Center
Jerusalem, Israel
Sheba Medical Center
Ramat Gan, Israel
Azienda Ospedaliera - Universitaria Consorziale Policlinico di Bari
Bari, Italy
Policlinico Di Sant Orsola Malpighi
Bologna, Italy
Azienda Ospedaliera Ospedale Niguarda Cà Granda
Milan, 20162, Italy
Centro Cardiologico Monzino
Milan, Italy
Azienda Ospedaliera San Gerardo
Monza, Italy
Chest Disease Hospital
Kuwait City, Kuwait
Amsterdam UMC - Locatie AMC
Amsterdam, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
Universitair Medisch Centrum Groningen
Groningen, Netherlands
Leids Universitair Medisch Centrum (LUMC)
Leiden, Netherlands
St Antonius Ziekenhuis
Nieuwegein, Netherlands
Erasmus Medisch Centrum
Rotterdam, Netherlands
HagaZiekenhuis - Locatie Leyweg
The Hague, Netherlands
Christ Church Hospital
Christchurch, 8011, New Zealand
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 61-848, Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, 02-097, Poland
Narodowy Instytut Kardiologii - Stefana kardynała Wyszyńskiego
Warsaw, 04-628, Poland
Slaskie Centrum Chorob Serca
Zabrze, Poland
Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz
Carnaxide, Portugal
Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE
Lisbon, Portugal
King Fahad Armed Forces Hospital
Jeddah, 21159, Saudi Arabia
King Faisal Specialist Hospital & Research Centre
Riyadh, Saudi Arabia
Hospital Universitario da Coruña
A Coruña, Spain
Hospital Universitari Bellvitge
Barcelona, Spain
Hospital Universitario Reina Sofía
Córdoba, Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Spain
Hospital Universitario y Politécnico La Fe
Valencia, Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden
Skånes Universitetssjukhus
Skåne, Sweden
Universitätsspital Basel
Basel, 4031, Switzerland
Inselspital - Universitätsspital Bern
Bern, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Istituto Cardiocentro Ticino
Lugano, Switzerland
UniversitätsSpital Zürich
Zurich, Switzerland
Glenfield Hospital
Leicester, United Kingdom
Kings College Hospital NHS Foundation Trust
London, United Kingdom
Related Publications (1)
Boersma LVA, Amin A, Clementy N, Duncker D, Engel G, Epstein L, Kuriachan V, Frazier-Mills C, Gwechenberger M, Nishii N, Lande J, Wiggenhorn C, Crozier I. Design of a post-market registry for the extravascular implantable cardioverter-defibrillator: The Enlighten Study. Heart Rhythm O2. 2024 Oct 16;6(1):64-69. doi: 10.1016/j.hroo.2024.09.022. eCollection 2025 Jan.
PMID: 40224263DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2023
First Posted
September 21, 2023
Study Start
September 1, 2023
Primary Completion (Estimated)
May 31, 2030
Study Completion (Estimated)
October 31, 2037
Last Updated
July 30, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share