Status:
ACTIVE_NOT_RECRUITING
Enlighten Study: The EV-ICD Post Approval Registry
Lead Sponsor:
Medtronic
Conditions:
Ventricular Arrhythmia
Tachycardia
Eligibility:
All Genders
Brief 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...
Detailed 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 bas...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2037
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06048731
Start Date
September 1 2023
End Date
October 31 2037
Last Update
July 30 2025
Active Locations (131)
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1
Cardiology Associates Medical Group
Huntington Park, California, United States, 93003
2
Sequoia Hospital
Redwood City, California, United States, 94062
3
University of California San Diego
San Diego, California, United States, 92093
4
Stanford Hospital & Clinics
Stanford, California, United States, 94305