Enlighten Study: The EV-ICD Post Approval Registry

Purpose

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.

Conditions

  • Ventricular Arrhythmia
  • Tachycardia

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts 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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114-2621

More Details

Status
Recruiting
Sponsor
Medtronic

Study Contact

EV-ICD PAS/PMCF Study manager
18006338766
rs.productsurveillanceregistry@medtronic.com

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 approximately every 6 months, but at least annually, or as prompted by reportable adverse events. The total estimated registry duration is is through lifetime of device.