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Atrial Fibrillation Detected by Continuous ECG Monitoring

NCT02036450 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6000

Last updated 2021-03-10

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Implantable loop recorder (Medtronic Reveal LINQ(TM))

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.

Sponsors & Collaborators

  • Bispebjerg Hospital

    collaborator OTHER

  • Zealand University Hospital

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • University of Southern Denmark

    collaborator OTHER

  • Aalborg University

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Jesper H Svendsen, MD, DMSc · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2020-02-29
Completion
2021-03-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

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 NCT02036450 on ClinicalTrials.gov