Clinical trial NCT06048731: Enlighten Study: the EV-ICD Post Approval Registry
Official title: Enlighten Study: the EV-ICD Post Approval Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ventricular Arrhythmia
Tachycardia
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2023-09-21
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Complication-free survival rate
timeFrame: 5 years
Secondary outcomes:
measure: System and/or procedure related complication-free survival
timeFrame: 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)
measure: Abnormal battery depletion complications
timeFrame: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
measure: Summarize all device system revisions
timeFrame: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
measure: Patient deaths
timeFrame: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
measure: Patient demographics and baseline medical history
timeFrame: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
measure: Characterize extracardiac pacing sensation
timeFrame: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
measure: Summarize ATP with spontaneous arrhythmias
timeFrame: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
measure: Characterize asystole pacing
timeFrame: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
measure: Characterize sensing and detection
timeFrame: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
measure: To characterize defibrillation shock effectiveness for terminating spontaneous VT/VF arrhythmia
timeFrame: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
measure: Characterize lead location and lead motion at implant.
timeFrame: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Other outcomes:
Locations:
city: Huntington Park
country: United States
facility: Cardiology Associates Medical Group
state: California
city: Redwood City
country: United States
facility: Sequoia Hospital
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Stanford
country: United States
facility: Stanford Hospital & Clinics
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Clearwater
country: United States
facility: Clearwater Cardiovascular Consultants
state: Florida
city: Jacksonville
country: United States
facility: Baptist Health
state: Florida
city: Panama City
country: United States
facility: Cardiovascular Institute of Northwest Florida
state: Florida
city: Sarasota
country: United States
facility: Intercoastal Medical Group
state: Florida
city: Marietta
country: United States
facility: Wellstar Research Institute
state: Georgia
city: Newburgh
country: United States
facility: Deaconess Specialty Physicians
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Louisville
country: United States
facility: Norton Heart and Vascular Institute
state: Kentucky
city: Salisbury
country: United States
facility: TidalHealth Peninsula Regional
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Woman's Hospital
state: Massachusetts
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Heart
state: Michigan
city: Coon Rapids
country: United States
facility: Metropolitan Cardiology Consultants
state: Minnesota
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center Fairview
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Saint Luke's Health System
state: Missouri
city: Kansas City
country: United States
facility: University of Kansas Medical Center Research Institute
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Marlton
country: United States
facility: Virtua Health
state: New Jersey
city: Morristown
country: United States
facility: Atlantic Health System
state: New Jersey
city: Albuquerque
country: United States
facility: Presbyterian Heart Group
state: New Mexico
city: Bay Shore
country: United States
facility: Northwell Health South Shore University Hospital
state: New York
city: Huntington
country: United States
facility: Northwell Health Huntington Hospital
state: New York
city: Manhasset
country: United States
facility: Northwell Health North Shore University Hospital
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: New York-Presbyterian Hospital Columbia University
state: New York
city: New York
country: United States
facility: New York - Presbyterian Hospital / Weill Cornell Medical Center
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Heart Center
state: New York
city: Staten Island
country: United States
facility: Northwell Health Staten Island University Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center (DUMC)
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital Health Network CRD
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Research Institute (OHRI)
state: Ohio
city: Bethlehem
country: United States
facility: Saint Luke's University Health Network
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center UPMC Passavant
state: Pennsylvania
city: Pittsburg
country: United States
facility: University of Pittsburgh Medical Center UPMC Presbyterian
state: Pennsylvania
city: Pittsburg
country: United States
facility: University of Pittsburgh Medical Center UPMC Shadyside
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley Medical Center
state: Pennsylvania
city: Memphis
country: United States
facility: The Stern Cardiovascular Foundation
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Saint Thomas Research Institute
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Dallas
country: United States
facility: Consultants in Cardiology (Fort Worth)
state: Texas
city: Fort Worth
country: United States
facility: Heart Center of North Texas
state: Texas
city: Plano
country: United States
facility: Baylor Research Institute
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Milwaukee
country: United States
facility: Aurora Cardiovascular Services
state: Wisconsin
city: Graz
country: Austria
facility: LKH - Universitätsklinikum Graz
city: Innsbruck
country: Austria
facility: Aö Landeskrankenhaus - Universitätskliniken Innsbruck
city: Linz
country: Austria
facility: Kepler Universitätsklinikum Med Campus III
city: Wien
country: Austria
facility: Allgemeines Krankenhaus - Universitätskliniken Wien
city: Brugge
country: Belgium
facility: AZ Sint Jan Brugge-Oostende av
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Calgary
country: Canada
facility: University Of Calgary
state: Alberta
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumo
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre (MUHC)
city: Prague
country: Czechia
facility: Nemocnice Na Homolce
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Clermont Ferrand
country: France
facility: Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
city: La Tronche
country: France
facility: Centre Hospitalier Universitaire de Grenoble - Site Nord
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille
city: Montpellier
country: France
facility: OC Santé - Clinique du Millénaire
city: Nantes Cedex 1
country: France
facility: Hôpital Guillaume et René Laënnec - CHU de Nantes
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Paros Cedex 13
country: France
facility: Hopital Pitie-Salpetriere AP-HP
city: Pessac
country: France
facility: Hôpital Haut-Lévêque - CHU de Bordeaux
city: Rennes
country: France
facility: CHU de Rennes - Hôpital Pontchaillou
city: Saint-Avertin
country: France
facility: CHRU de Tours - Hôpital Trousseau
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
city: Bremen
country: Germany
facility: Elektrophysiologie Bremen - Im Klinikum Links der Weser
city: Hanover
country: Germany
facility: Medizinische Hochschule Hannover
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus
city: Tübingen
country: Germany
facility: Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen
city: Athens
country: Greece
facility: Hippokration General Hospital of Athens
city: Thessaloníki
country: Greece
facility: George Papanikolaou General Hospital
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Budapest
country: Hungary
facility: Semmelweis Egyetem AOK
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Ancona
country: Italy
facility: Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona
city: Bari
country: Italy
facility: Azienda Ospedaliera - Universitaria Consorziale Policlinico di Bari
city: Bologna
country: Italy
facility: Policlinico Di Sant Orsola Malpighi
city: Milano
country: Italy
facility: Azienda Ospedaliera Ospedale Niguarda Cà Granda
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
city: Monza
country: Italy
facility: Azienda Ospedaliera San Gerardo
city: Kuwait
country: Kuwait
facility: Chest Disease Hospital
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC - Locatie AMC
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis - Locatie Leyweg
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum (LUMC)
city: Nieuwegein
country: Netherlands
facility: St Antonius Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Christchurch
country: New Zealand
facility: Christ Church Hospital
city: Poznań
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Poznaniu
city: Warsaw
country: Poland
facility: Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
city: Warsaw
country: Poland
facility: Narodowy Instytut Kardiologii - Stefana kardynała Wyszyńskiego
city: Zabrze
country: Poland
facility: Slaskie Centrum Chorob Serca
city: Carnaxide
country: Portugal
facility: Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE
city: Jeddah
country: Saudi Arabia
facility: King Fahad Armed Forces Hospital
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Centre
city: Barcelona
country: Spain
facility: Hospital Universitari Bellvitge
city: Coruña
country: Spain
facility: Hospital Universitario da Coruña
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Girona
country: Spain
facility: Hospital Universitari de Girona Doctor Josep Trueta
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Skåne
country: Sweden
facility: Skånes Universitetssjukhus
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Bern
country: Switzerland
facility: Inselspital - Universitätsspital Bern
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Lugano
country: Switzerland
facility: Istituto Cardiocentro Ticino
city: Zurich
country: Switzerland
facility: UniversitätsSpital Zürich
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
city: London
country: United Kingdom
facility: Kings College Hospital NHS Foundation Trust
Study officials:
References: