Summary

at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The Reveal LINQ Registry will generate reliable long-term "real world" data of product performance, economic valuation, site-of-service procedural information.

Official Title

Medtronic Reveal LINQ Insertable Cardiac Monitor Registry

Details

The study is a prospective, non-randomized, observational, multi-center, global study. The study will characterize clinical actions initiated by Reveal LINQ arrhythmia detection and estimate procedure-related acute infection rate. Approximately 1,500 subjects will be implanted with a Reveal LINQ ICM and undergo continuous remote monitoring and be followed prospectively from insertion through 18 months.

Keywords

Arrhythmias, Cardiac Reveal LINQ

Eligibility

You can join if…

  • Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements.
  • Subject is intended to receive or be treated with the have a Reveal LINQ ICM inserted in the next 30 days.
  • Patient enrolled before or on the same date of insertion of the Reveal LINQ ICM
  • Subject consent prior to ICM insertion

You CAN'T join if...

  • Subject who is, or is expected to be inaccessible for follow-up
  • Subject with exclusion criteria required by local law
  • Subject is currently enrolled in or plans to enroll a concurrent study that may confound the results of this study. Co-enrollment in any concurrent drug and/or device clinical study (including registries) requires approval of the study manager or designee.

Locations

  • University of California San Francisco UCSF Medical Center
    San Francisco California 94143-0138 United States
  • Baylor Research Institute (Fort Worth TX)
    Fort Worth Texas 76104-4110 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
ID
NCT02746471
Study Type
Observational
Last Updated