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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Defibrillation using EV-ICD | Device | Device: Defibrillation using the Extravascular ICD (EV-ICD) |
| Measure | Description | Time Frame |
|---|---|---|
| Complication-free survival rate | To demonstrate 5-year Aurora EV-ICD major system-related complication-free survival > 79% | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology Associates Medical Group | Huntington Park | California | 93003 | United States | ||
| Sequoia Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40224263 | Derived | 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. |
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| 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) |
| 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) |
| 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 |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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