Tachycardia, Ventricular Arrhythmia
Conditions
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 based on market release dates for EV-ICD System within the geography in which the subject is enrolled. Patients enrolled in the Enlighten Study will be prospectively followed for the life time of device post-implant or until registry closure, patient death or patient exit from the registry (i.e., withdrawal of consent). Successfully implanted patients are expected to have scheduled follow-up visits per routine clinical care, at least annually, or as prompted by reportable adverse events. The total estimated registry duration is through lifetime of device.
Interventions
DEVICEDefibrillation using EV-ICD
Device: Defibrillation using the Extravascular ICD (EV-ICD)
Sponsors
Medtronic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complication-free survival rate | 5 years | To demonstrate 5-year Aurora EV-ICD major system-related complication-free survival \> 79% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abnormal battery depletion complications | Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years) | Characterize the rate of abnormal battery depletion complications as a function of time post-implant |
| Summarize all device system revisions | Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years) | Summarize all device system revisions (e.g., reposition, replacement, explant) including reasons for modification and action taken |
| Patient deaths | Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years) | Summarize patient deaths |
| Patient demographics and baseline medical history | Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years) | Summarize patient demographics and baseline medical history |
| Characterize extracardiac pacing sensation | Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years) | Characterize extracardiac pacing sensation |
| System and/or procedure related complication-free survival | Procedure related complications assessed during and after the procedure/surgery; system related complications assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years) | To estimate the Aurora EV-ICD major system and/or procedure related complication-free survival probability as a function of time post-implant |
| Characterize asystole pacing | Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years) | Characterize asystole pacing |
| Characterize sensing and detection | Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years) | Characterize sensing and detection |
| To characterize defibrillation shock effectiveness for terminating spontaneous VT/VF arrhythmia | Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years) | Characterize high voltage therapy effectiveness on device detected spontaneous ventricular episodes |
| Characterize lead location and lead motion at implant. | Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years) | Characterize lead location and lead motion at implant. |
| Summarize ATP with spontaneous arrhythmias | Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years) | Summarize ATP with spontaneous arrhythmias |
Countries
Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Kuwait, Netherlands, New Zealand, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, United Kingdom, United States
Outcome results
None listed