Enlighten Study: The EV-ICD Post Approval Registry

RECRUITING

I'm interested ...!!

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.

Conditions:

🦠 Ventricular Arrhythmia 🦠 Tachycardia

🗓️ Study Start (Actual) 1 September 2023

🗓️ Primary Completion (Estimated) 31 May 2030

✅ Study Completion (Estimated) 31 October 2037

👥 Enrollment (Estimated) 1000

🔬 Study Type OBSERVATIONAL

📊 Phase N/A

Locations:

📍 Birmingham, Alabama, United States

📍 Huntington Park, California, United States

📍 Redwood City, California, United States

📍 Stanford, California, United States

📍 Hartford, Connecticut, United States

📍 Clearwater, Florida, United States

📍 Jacksonville, Florida, United States

📍 Panama City, Florida, United States

📍 Newburgh, Indiana, United States

📍 West Des Moines, Iowa, United States

📍 Louisville, Kentucky, United States

📍 Boston, Massachusetts, United States

📍 Lansing, Michigan, United States

📍 Ypsilanti, Michigan, United States

📍 Minneapolis, Minnesota, United States

📍 Rochester, Minnesota, United States

📍 Kansas City, Missouri, United States

📍 Saint Louis, Missouri, United States

📍 Marlton, New Jersey, United States

📍 Morristown, New Jersey, United States

📍 Albuquerque, New Mexico, United States

📍 Bay Shore, New York, United States

📍 Huntington, New York, United States

📍 Manhasset, New York, United States

📍 New Hyde Park, New York, United States

📍 New York, New York, United States

📍 Poughkeepsie, New York, United States

📍 Staten Island, New York, United States

📍 Durham, North Carolina, United States

📍 Cincinnati, Ohio, United States

📍 Cleveland, Ohio, United States

📍 Columbus, Ohio, United States

📍 Bethlehem, Pennsylvania, United States

📍 Pittsburgh, Pennsylvania, United States

📍 Wilkes-Barre, Pennsylvania, United States

📍 Memphis, Tennessee, United States

📍 Nashville, Tennessee, United States

📍 Austin, Texas, United States

📍 Dallas, Texas, United States

📍 Fort Worth, Texas, United States

📍 Plano, Texas, United States

📍 Charlottesville, Virginia, United States

📍 Milwaukee, Wisconsin, United States

📍 Graz, Austria

📍 Innsbruck, Austria

📍 Linz, Austria

📍 Wien, Austria

📍 Brugge, Belgium

📍 Brussel, Belgium

📍 Calgary, Alberta, Canada

📍 Montréal, Quebec, Canada

📍 Québec, Quebec, Canada

📍 Prague, Czechia

📍 Odense, Denmark

📍 Helsinki, Finland

📍 Clermont Ferrand, France

📍 La Tronche, France

📍 Lille, France

📍 Montpellier, France

📍 Nantes Cedex 1, France

📍 Paris, France

📍 Pessac, France

📍 Rennes, France

📍 Saint-Avertin, France

📍 Bad Oeynhausen, Germany

📍 Bremen, Germany

📍 Hanover, Germany

📍 Stuttgart, Germany

📍 Tübingen, Germany

📍 Thessaloníki, Greece

📍 Hong Kong, Hong Kong

📍 Budapest, Hungary

📍 Ramat Gan, Israel

📍 Bari, Italy

📍 Milano, Italy

📍 Kuwait, Kuwait

📍 Amsterdam, Netherlands

📍 Den Haag, Netherlands

📍 Enschede, Netherlands

📍 Groningen, Netherlands

📍 Leiden, Netherlands

📍 Nieuwegein, Netherlands

📍 Rotterdam, Netherlands

📍 Christchurch, New Zealand

📍 Oslo, Norway

📍 Poznań, Poland

📍 Warsaw, Poland

📍 Zabrze, Poland

📍 Carnaxide, Portugal

📍 Lisboa, Portugal

📍 Riyadh, Saudi Arabia

📍 Barcelona, Spain

📍 Coruña, Spain

📍 Córdoba, Spain

📍 Girona, Spain

📍 Granada, Spain

📍 Palma De Mallorca, Spain

📍 Valencia, Spain

📍 Göteborg, Sweden

📍 Skåne, Sweden

📍 Bern, Switzerland

📍 Lausanne, Switzerland

📍 Lugano, Switzerland

📍 Zurich, Switzerland

📍 Leicester, United Kingdom

📍 London, United Kingdom

More locations available...

📋 Eligibility Criteria

Description

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

Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 30 August 2023
First Submitted that Met QC Criteria 20 September 2023
First Posted 21 September 2023

Study Record Updates

Last Update Submitted that Met QC Criteria 17 July 2024
Last Update Posted 18 July 2024
Last Verified July 2024