Skip to main content
OpenTrials
Completed

NCT Number: NCT02746471

Reveal LINQ Registry

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Ziekenhuis Oost Limburg - Campus St.-Jan, Leuven, Belgium

Loading trial locations.

About this study

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 36 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Reveal LINQ

Device

Primary outcomes

  1. Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature

    Time frame: Implant to 36 months post-implant

    Clinical actions taken over the course of study follow-up

  2. Number of Participants With Procedure-related Acute Infection Rate

    Time frame: Implant to 30 days post-implant

    Acute infection rate in the subjects who were followed for at least 30 days or had an infection prior to 30 days. Infections are as assessed by the Investigator and defined as deep incision site or superficial infection.

    Deep incision site are classified as pain, redness, or drainage at incision site requiring the device to be removed or IV antibiotics administered.

    Superficial infections are defined as redness beyond procedure expectation and oral antibiotics administered.

    For both deep incision and superficial infections, a physician directed intervention must occur for the event to be defined as an infection.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

Medtronic Reveal LINQ Insertable Cardiac Monitor Registry

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Apr 21, 2016
Registry last updated
Jul 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.