Enlighten Study: the EV-ICD Post Approval Registry
- Conditions
- TachycardiaVentricular Arrhythmia
- Registration Number
- NCT06048731
- Lead Sponsor
- Medtronic
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complication-free survival rate 5 years To demonstrate 5-year Aurora EV-ICD major system-related complication-free survival \> 79%
- Secondary Outcome Measures
Name Time Method 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) Summarize ATP with spontaneous arrhythmias
Characterize asystole pacing Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years) Characterize asystole pacing
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) Summarize all device system revisions (e.g., reposition, replacement, explant) including reasons for modification and action taken
Patient deaths Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years) Summarize patient deaths
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) To estimate the Aurora EV-ICD major system and/or procedure related complication-free survival probability as a function of time post-implant
Characterize sensing and detection Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years) Characterize sensing and detection
To characterize defibrillation shock effectiveness for terminating spontaneous VT/VF arrhythmia Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years) Characterize high voltage therapy effectiveness on device detected spontaneous ventricular episodes
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) Characterize lead location and lead motion at implant.
Abnormal battery depletion complications Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years) Characterize the rate of abnormal battery depletion complications as a function of time post-implant
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) Summarize patient demographics and baseline medical history
Characterize extracardiac pacing sensation Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years) Characterize extracardiac pacing sensation
Trial Locations
- Locations (134)
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
🇵🇹Lisboa, Portugal
King Fahad Armed Forces Hospital
🇸🇦Jeddah, Saudi Arabia
King Faisal Specialist Hospital & Research Centre
🇸🇦Riyadh, Saudi Arabia
Hospital Universitari Bellvitge
🇪🇸Barcelona, Spain
Hospital Universitario da Coruña
🇪🇸Coruña, 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
Inselspital - Universitätsspital Bern
🇨🇭Bern, Switzerland
Norton Heart and Vascular Institute
🇺🇸Louisville, Kentucky, 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
Deaconess Specialty Physicians
🇺🇸Newburgh, Indiana, United States
Iowa Heart Center
🇺🇸West Des Moines, Iowa, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Wellstar Research Institute
🇺🇸Marietta, Georgia, United States
Hopital Pitie-Salpetriere AP-HP
🇫🇷Paros Cedex 13, France
Hippokration General Hospital of Athens
🇬🇷Athens, Greece
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
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
🇺🇸Saint 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
University of Pittsburgh Medical Center UPMC Passavant
🇺🇸Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center UPMC Presbyterian
🇺🇸Pittsburg, Pennsylvania, United States
University of Pittsburgh Medical Center UPMC Shadyside
🇺🇸Pittsburg, 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
🇦🇹Wien, Austria
AZ Sint Jan Brugge-Oostende av
🇧🇪Brugge, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Brussel
🇧🇪Brussel, Belgium
University Of Calgary
🇨🇦Calgary, Alberta, Canada
Montreal Heart Institute
🇨🇦Montréal, 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 Cedex 1, 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
George Papanikolaou General Hospital
🇬🇷Thessaloníki, Greece
Prince of Wales Hospital
🇭🇰Hong Kong, Hong Kong
Semmelweis Egyetem AOK
🇭🇺Budapest, Hungary
Soroka Medical Center
🇮🇱Be'er Sheva, Israel
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Sheba Medical Center
🇮🇱Ramat Gan, Israel
Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona
🇮🇹Ancona, Italy
Azienda Ospedaliera - Universitaria Consorziale Policlinico di Bari
🇮🇹Bari, Italy
Policlinico Di Sant Orsola Malpighi
🇮🇹Bologna, Italy
Azienda Ospedaliera Ospedale Niguarda Cà Granda
🇮🇹Milano, Italy
Centro Cardiologico Monzino
🇮🇹Milano, Italy
Azienda Ospedaliera San Gerardo
🇮🇹Monza, Italy
Chest Disease Hospital
🇰🇼Kuwait, Kuwait
Amsterdam UMC - Locatie AMC
🇳🇱Amsterdam, Netherlands
HagaZiekenhuis - Locatie Leyweg
🇳🇱Den Haag, 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
Christ Church Hospital
🇳🇿Christchurch, New Zealand
Uniwersytecki Szpital Kliniczny w Poznaniu
🇵🇱Poznań, Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
🇵🇱Warsaw, Poland
Narodowy Instytut Kardiologii - Stefana kardynała Wyszyńskiego
🇵🇱Warsaw, Poland
Sahlgrenska Universitetssjukhuset
🇸🇪Göteborg, Sweden
Skånes Universitetssjukhus
🇸🇪Skåne, Sweden
Universitätsspital Basel
🇨🇭Basel, 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