Enlighten Study: The EV-ICD Post Approval Registry

Tachycardia Clinical Trial

Official title:

Enlighten Study: The EV-ICD Post Approval Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06048731
• Other study ID #: PSR: EV-ICD PAS/PMCF
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: October 31, 2037

Study information

• Verified date: June 2024
• Source: Medtronic
• Contact: EV-ICD PAS/PMCF Study manager
• Phone: 18006338766
• Email: rs.productsurveillanceregistry[@]medtronic.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 approximately every 6 months, but at least annually, or as prompted by reportable adverse events. The total estimated registry duration is is through lifetime of device.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 31, 2037
• Est. primary completion date: May 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Tachycardia
• Ventricular Arrhythmia

Intervention

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

Locations

Country	Name	City	State
Austria	LKH - Universitätsklinikum Graz	Graz
Austria	Aö Landeskrankenhaus - Universitätskliniken Innsbruck	Innsbruck
Austria	Kepler Universitätsklinikum Med Campus III	Linz
Belgium	AZ Sint Jan Brugge-Oostende av	Brugge
Belgium	Universitair Ziekenhuis Brussel	Brussel
Canada	University Of Calgary	Calgary	Alberta
Canada	Montreal Heart Institute	Montréal	Quebec
Canada	Institut Universitaire de Cardiologie et de Pneumo	Québec	Quebec
Czechia	Nemocnice Na Homolce	Prague
Denmark	Odense Universitetshospital	Odense
Finland	Helsinki University Hospital	Helsinki
France	Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied	Clermont Ferrand
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	Hôpital Haut-Lévêque - CHU de Bordeaux	Pessac
France	CHU de Rennes - Hôpital Pontchaillou	Rennes
France	CHRU de Tours - Hôpital Trousseau	Saint-Avertin
Germany	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
Greece	George Papanikolaou General Hospital	Thessaloníki
Hungary	Semmelweis Egyetem AOK	Budapest
Kuwait	Chest Disease Hospital	Kuwait
Netherlands	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
New Zealand	Christ Church Hospital	Christchurch
Norway	Oslo Universitetssykehus-Rikshospitalet	Oslo
Poland	Uniwersytecki Szpital Kliniczny w Poznaniu	Poznan
Poland	Narodowy Instytut Kardiologii - Stefana kardynala Wyszynskiego	Warsaw
Poland	Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warsaw
Poland	Slaskie Centrum Chorob Serca	Zabrze
Portugal	Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz	Carnaxide
Portugal	Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE	Lisboa
Spain	Hospital Universitari Bellvitge	Barcelona
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital Universitario da Coruña	Coruña
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
Sweden	Sahlgrenska Universitetssjukhuset	Göteborg
Sweden	Skånes Universitetssjukhus	Skåne
Switzerland	Inselspital - Universitätsspital Bern	Bern
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	Istituto Cardiocentro Ticino	Lugano
Switzerland	UniversitätsSpital Zürich	Zurich
United Kingdom	Glenfield Hospital	Leicester
United Kingdom	Kings College Hospital NHS Foundation Trust	London
United States	Presbyterian Heart Group	Albuquerque	New Mexico
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	Northwell Health South Shore University Hospital	Bay Shore	New York
United States	Saint Luke's University Health Network	Bethlehem	Pennsylvania
United States	The University of Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	The Christ Hospital Health Network CRD	Cincinnati	Ohio
United States	Clearwater Cardiovascular Consultants	Clearwater	Florida
United States	Cleveland Clinic	Cleveland	Ohio
United States	OhioHealth Research Institute (OHRI)	Columbus	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Consultants in Cardiology (Fort Worth)	Dallas	Texas
United States	Duke University Medical Center (DUMC)	Durham	North Carolina
United States	Heart Center of North Texas	Fort Worth	Texas
United States	Hartford Hospital	Hartford	Connecticut
United States	Northwell Health Huntington Hospital	Huntington	New York
United States	Cardiology Associates Medical Group	Huntington Park	California
United States	Baptist Health	Jacksonville	Florida
United States	Saint Luke's Health System	Kansas City	Missouri
United States	University of Kansas Medical Center Research Institute	Kansas City	Missouri
United States	Sparrow Clinical Research Institute	Lansing	Michigan
United States	Norton Heart Specialists	Louisville	Kentucky
United States	Northwell Health North Shore University Hospital	Manhasset	New York
United States	Virtua Health	Marlton	New Jersey
United States	The Stern Cardiovascular Foundation	Memphis	Tennessee
United States	Aurora Cardiovascular Services	Milwaukee	Wisconsin
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
United States	University of Minnesota Medical Center Fairview	Minneapolis	Minnesota
United States	Atlantic Health System	Morristown	New Jersey
United States	Saint Thomas Research Institute	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	New York - Presbyterian Hospital / Weill Cornell Medical Center	New York	New York
United States	NYU Langone Medical Center	New York	New York
United States	Deaconess Specialty Physicians	Newburgh	Indiana
United States	Cardiovascular Institute of Northwest Florida	Panama City	Florida
United States	University of Pittsburgh Medical Center UPMC Passavant	Pittsburgh	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	Baylor Research Institute	Plano	Texas
United States	Hudson Valley Heart Center	Poughkeepsie	New York
United States	Sequoia Hospital	Redwood City	California
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Stanford Hospital & Clinics	Stanford	California
United States	Northwell Health Staten Island University Hospital	Staten Island	New York
United States	Iowa Heart Center	West Des Moines	Iowa
United States	Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania
United States	Michigan Heart	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Hungary,  Kuwait,  Netherlands,  New Zealand,  Norway,  Poland,  Portugal,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication-free survival rate	To demonstrate 5-year Aurora EV-ICD system-related complication-free survival > 79%	5 years
Secondary	System and/or procedure related complication-free survival	To estimate the Aurora EV-ICD 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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)