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Usability Study to Assess the Reveal LINQ Insertable Cardiac Monitor System

NCT01965899 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2016-09-23

Study results available
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Summary

The purpose of the Reveal LINQ Usability Study is to assess the functionality of the Reveal LINQ insertable cardiac monitor and accompanying system in patients indicated for an insertable cardiac monitor

Conditions

  • Syncope
  • Recurrent Symptomatic Atrial Fibrillation

Interventions

DEVICE

Insertable Cardiac Monitor Implant

The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Helmut Pürerfellner, MD · Allgemein öffentliches Krankenhaus der Elisabethinen Linz

  • Lukas Dekker, MD · Catharina Ziekenhuis

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-07-31
Completion
2015-09-30

Countries

  • Australia
  • Austria
  • Belgium
  • Netherlands
  • Russia
  • Slovakia
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01965899 on ClinicalTrials.gov