Enlighten Study: the EV-ICD Post Approval Registry
Launched by MEDTRONIC · Sep 20, 2023
Trial Information
Current as of May 20, 2025
Active, not recruiting
Keywords
ClinConnect Summary
The Enlighten Study is a clinical trial sponsored by Medtronic that aims to evaluate the safety and effectiveness of a device called the EV-ICD, which is used to help manage serious heart conditions like ventricular arrhythmia and tachycardia. This study is important as it takes place after the EV-ICD is already available to patients, allowing researchers to see how well it works in everyday medical settings.
To participate in this study, patients must be scheduled to receive the EV-ICD device and will need to give their written consent or have a representative do so. It's important that participants can be followed up after the procedure, so those who cannot be reached later or are involved in other conflicting studies may not be eligible. If you join the study, you can expect close monitoring and support while the researchers collect valuable information about your treatment and its effects. This research will help improve care for future patients with similar heart conditions.
Gender
ALL
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
About Medtronic
Medtronic is a global leader in medical technology, dedicated to transforming patient care through innovative solutions and therapies. With a rich history of pioneering advancements in cardiovascular, diabetes, neurological, and orthopedic care, Medtronic is committed to improving health outcomes and enhancing the quality of life for patients worldwide. The company actively sponsors clinical trials to evaluate the safety and efficacy of its products, ensuring that rigorous scientific standards are met. Through collaboration with healthcare professionals and institutions, Medtronic seeks to drive clinical research that supports evidence-based practices and fosters advancements in medical science.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
Saint Louis, Missouri, United States
Brussels, , Belgium
New Hyde Park, New York, United States
Wilkes Barre, Pennsylvania, United States
Danville, Pennsylvania, United States
Cleveland, Ohio, United States
Hartford, Connecticut, United States
Enschede, , Netherlands
Calgary, Alberta, Canada
Ypsilanti, Michigan, United States
Minneapolis, Minnesota, United States
Paris, , France
Salisbury, Maryland, United States
Charlottesville, Virginia, United States
Stuttgart, , Germany
Milano, , Italy
Nieuwegein, , Netherlands
Hong Kong, , Hong Kong
Córdoba, , Spain
Redwood City, California, United States
Birmingham, Alabama, United States
Coon Rapids, Minnesota, United States
Copenhagen, , Denmark
Helsinki, , Finland
Ramat Gan, , Israel
Basel, , Switzerland
Leicester, , United Kingdom
Jerusalem, , Israel
Zurich, , Switzerland
Minneapolis, Minnesota, United States
Odense, , Denmark
Durham, North Carolina, United States
Leiden, , Netherlands
Poughkeepsie, New York, United States
Zabrze, , Poland
Lausanne, , Switzerland
Granada, , Spain
Fort Worth, Texas, United States
Monza, , Italy
Boston, Massachusetts, United States
San Diego, California, United States
Albuquerque, New Mexico, United States
Rotterdam, , Netherlands
Lansing, Michigan, United States
Pittsburgh, Pennsylvania, United States
Milwaukee, Wisconsin, United States
Austin, Texas, United States
Barcelona, , Spain
Plano, Texas, United States
Columbus, Ohio, United States
Lille, , France
Hanover, , Germany
Pessac, , France
Be'er Sheva, , Israel
Graz, , Austria
Bad Oeynhausen, , Germany
Córdoba, , Spain
Athens, , Greece
Budapest, , Hungary
Den Haag, , Netherlands
Sarasota, Florida, United States
Marietta, Georgia, United States
Groningen, , Netherlands
Brussel, , Belgium
Tours, , France
Paris, , France
Wien, , Austria
Göteborg, , Sweden
Clearwater, Florida, United States
Bern, , Switzerland
Milano, , Italy
Rennes, , France
Tübingen, , Germany
Jacksonville, Florida, United States
Stanford, California, United States
Jeddah, , Saudi Arabia
London, , United Kingdom
Girona, , Spain
Valencia, , Spain
Kansas City, Missouri, United States
Brugge, , Belgium
Riyadh, , Saudi Arabia
Lisboa, , Portugal
Palma De Mallorca, , Spain
Boston, Massachusetts, United States
New York, New York, United States
Morristown, New Jersey, United States
Prague, , Czechia
West Des Moines, Iowa, United States
Montréal, Quebec, Canada
Ancona, , Italy
Panama City, Florida, United States
Oslo, , Norway
Louisville, Kentucky, United States
Amsterdam, , Netherlands
Carnaxide, , Portugal
Coruña, , Spain
Manhasset, New York, United States
Lugano, , Switzerland
Marlton, New Jersey, United States
Warsaw, , Poland
Poznań, , Poland
Tyler, Texas, United States
Nashville, Tennessee, United States
Linz, , Austria
Columbus, Ohio, United States
Christchurch, , New Zealand
Clermont Ferrand, , France
Montpellier, , France
Nantes Cedex 1, , France
Saint Avertin, , France
Warsaw, , Poland
Skåne, , Sweden
Huntington Park, California, United States
Kansas City, Missouri, United States
Bay Shore, New York, United States
Huntington, New York, United States
Staten Island, New York, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Dallas, Texas, United States
Bremen, , Germany
Kuwait, , Kuwait
Innsbruck, , Austria
Thessaloníki, , Greece
Newburgh, Indiana, United States
New York, New York, United States
Cincinnati, Ohio, United States
Bethlehem, Pennsylvania, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Québec, Quebec, Canada
Montreal, , Canada
La Tronche, , France
Bari, , Italy
New York, New York, United States
Bologna, , Italy
Louisville, Kentucky, United States
Pittsburg, Pennsylvania, United States
Pittsburg, Pennsylvania, United States
Paros Cedex 13, , France
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported