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ACTIVE NOT RECRUITING
NCT06048731

Enlighten Study: The EV-ICD Post Approval Registry

Sponsor: Medtronic

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2023-09-01

Completion Date

2037-10-31

Last Updated

2025-07-30

Healthy Volunteers

No

Interventions

DEVICE

Defibrillation using EV-ICD

Device: Defibrillation using the Extravascular ICD (EV-ICD)

Locations (131)

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