Enlighten Study: The EV-ICD Post Approval Registry
Tachycardia | Ventricular ArrhythmiaMedtronic 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.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
0 and up
Participation 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
Study Location
Institut Universitaire de Cardiologie et de Pneumo
Institut Universitaire de Cardiologie et de PneumoQuébec, Quebec
Canada
Contact Study Team
Montreal Heart Institute
Montreal Heart InstituteMontréal, Quebec
Canada
Contact Study Team
University Of Calgary
University Of CalgaryCalgary, Alberta
Canada
Contact Study Team
- Study Sponsored By
- Medtronic
- Participants Required
- More Information
- Study ID:
NCT06048731