Enlighten Study: The EV-ICD Post Approval Registry
Running, not enrolling
Conditions studied: Ventricular Arrhythmia, Tachycardia
In brief
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 facts
- Study ID
- NCT06048731
- Run by
- Medtronic
- People needed
- 1000
- Starts
- 2023-09-01
- Expected to finish
- 2037-10-31
- Last updated by the study team
- 2025-07-30
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
- Cardiology Associates Medical Group — Huntington Park, California, United States
Full record on ClinicalTrials.gov
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