Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
1000 participants
OBSERVATIONAL
2023-09-01
2037-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Defibrillation using EV-ICD
Device: Defibrillation using the Extravascular ICD (EV-ICD)
Eligibility Criteria
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Inclusion Criteria
* 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 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
ALL
No
Sponsors
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Medtronic
INDUSTRY
Responsible Party
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Locations
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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
Deaconess Specialty Physicians
Newburgh, Indiana, United States
Iowa Heart Center
West Des Moines, Iowa, United States
Norton Heart and Vascular Institute
Louisville, Kentucky, United States
TidalHealth Peninsula Regional
Salisbury, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Woman's Hospital
Boston, Massachusetts, United States
Sparrow Clinical Research Institute
Lansing, Michigan, United States
Michigan Heart
Ypsilanti, Michigan, United States
Metropolitan Cardiology Consultants
Coon Rapids, Minnesota, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Saint Luke's Health System
Kansas City, Missouri, United States
University of Kansas Medical Center Research Institute
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Virtua Health
Marlton, New Jersey, United States
Atlantic Health System
Morristown, New Jersey, United States
Presbyterian Heart Group
Albuquerque, New Mexico, United States
Northwell Health South Shore University Hospital
Bay Shore, New York, United States
Northwell Health Huntington Hospital
Huntington, New York, United States
Northwell Health North Shore University Hospital
Manhasset, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
NYU Langone Medical Center
New York, New York, United States
New York-Presbyterian Hospital Columbia University
New York, New York, United States
New York - Presbyterian Hospital / Weill Cornell Medical Center
New York, New York, United States
Hudson Valley Heart Center
Poughkeepsie, New York, United States
Northwell Health Staten Island University Hospital
Staten Island, New York, United States
Duke University Medical Center (DUMC)
Durham, North Carolina, United States
The Christ Hospital Health Network CRD
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
OhioHealth Research Institute (OHRI)
Columbus, Ohio, United States
Saint Luke's University Health Network
Bethlehem, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center UPMC Shadyside
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center UPMC Passavant
Pittsburgh, Pennsylvania, United States
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States
The Stern Cardiovascular Foundation
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Saint Thomas Research Institute
Nashville, Tennessee, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Consultants in Cardiology (Fort Worth)
Dallas, Texas, United States
Heart Center of North Texas
Fort Worth, Texas, United States
Baylor Research Institute
Plano, Texas, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Aurora Cardiovascular Services
Milwaukee, Wisconsin, 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, , Belgium
University Of Calgary
Calgary, Alberta, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumo
Québec, Quebec, 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, , France
Centre Hospitalier Universitaire de Grenoble - Site Nord
La Tronche, , France
Centre Hospitalier Régional Universitaire de Lille
Lille, , France
OC Santé - Clinique du Millénaire
Montpellier, , France
Hôpital Guillaume et René Laënnec - CHU de Nantes
Nantes, , 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, , 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, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Robert-Bosch-Krankenhaus
Stuttgart, , Germany
Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen
Tübingen, , 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, , 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, , New Zealand
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, , Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, , Poland
Narodowy Instytut Kardiologii - Stefana kardynała Wyszyńskiego
Warsaw, , 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, , 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, , 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
Countries
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References
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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.
Other Identifiers
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PSR: EV-ICD PAS/PMCF
Identifier Type: -
Identifier Source: org_study_id
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