CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 6,000 enrolled
Drug / intervention
Implantable loop recorder (Medtronic Reveal LINQ(TM))device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT02036450N/ACompleted
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Atrial Fibrillation Detected by Continuous ECG Monitoring Using Implantable Loop Recorder to Prevent Stroke in High-risk Individuals.

Rigshospitalet, Denmark·interventional·Posted Jan 15, 2014·Updated Mar 10, 2021

In Brief

A clinical study evaluating Implantable loop recorder (Medtronic Reveal LINQ(TM)) for Atrial Fibrillation and 3 related conditions. Completed, enrolled 6,000 participants across 1 site.

Detailed Summary

The LOOP study aims to determine whether screening for atrial fibrillation (AF) with implantable loop recorder and initiation of oral anticoagulation (OAC) if AF is detected will reduce the risk of stroke and systemic arterial embolism in patients with risk factors for stroke.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Stroke, Hypertension, Diabetes
CountriesDenmark
CollaboratorsBispebjerg Hospital, Zealand University Hospital, Odense University Hospital, University of Southern Denmark, Aalborg University

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 15, 2014
Enrollment StartJan 1, 2014
Primary CompletionFeb 1, 2020
Study CompletionMar 1, 2021
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 12.5 years ago

Interventions

Implantable loop recorder (Medtronic Reveal LINQ(TM))device

The patients in the experimental arm receive an implantable loop recorder (Medtronic Reveal LINQ(TM)) with continuous monitoring, and are followed by daily automated remote transmissions. New arrhythmia episodes are reviewed daily by an experienced medical doctor. If AF lasting ≥6 minutes is detected and confirmed by at least two senior cardiologists, OAC is initiated. Decision about specific type of OAC, and possible further clinical work-up or treatment, is left to the treating physician and the patient. The remote monitoring continues until end of service of the device, patient withdrawal or other end-of-study.