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
  • Baylor Research Institute (Plano TX)
    Plano Texas 75093-3691 United States
  • Baylor Research Institute (Dallas-TX)
    Dallas Texas 75206 United States
  • Texas Cardiac Arrhythmia Research Foundation
    Austin Texas 78705 United States
  • Saint Lukes Health System
    Kansas City Missouri 64111-3220 United States
  • Iowa Heart Center
    Des Moines Iowa 50314 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
March 28, 2018