Atrial Fibrillation Detected by Continuous ECG Monitoring (LOOP)

March 8, 2021 updated by: Jesper Hastrup Svendsen, Rigshospitalet, Denmark

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background:

Ischemic stroke is an increasing health problem world-wide (Heidenreich PA, et al. Circulation 2011; PMID 21262990). At least 20% of ischemic strokes are attributable to atrial fibrillation (AF) (Marini C, et al. Stroke J Cereb Circ 2005; PMID 15879330). Another 30% are so-called cryptogenic, possibly related to undiagnosed AF (Brachmann J, et al. Circ Arrhythm Electrophysiol 2015; PMID 26763225). In approximately 30% of a general population of pacemaker or cardioverter defibrillator patients, previously unknown AF will be detected during the first 2-3 years after implantation (Healey JS, et al. N Engl J Med 2012; PMID 22236222; ASSERT). Although the majority of these AF episodes are short-lasting and asymptomatic, the ASSERT study found that such AF is associated with risk of stroke. Since this was published, screening for AF has received intensified attention by researchers and the industry, although available evidence does not yet support systematic mass screening.

-

Aims:

The LOOP study will determine whether long-term continuous screening and initiation of OAC for AF episodes lasting ≥6 minutes will reduce the risk of stroke in patients with stroke risk factors.

-

Methods:

Patients from the general population will receive a letter of invitation from one of four study centers located in 3 of Denmark's 5 administrative regions.

Eligible study participants must be ≥70 years old and have ≥1 of the following stroke risk factors; hypertension, diabetes, heart failure or previous stroke, while any history of AF or existing cardiac implantable electronic device are exclusion criteria.

A total of 6000 participants will be randomized 3:1 to control (n=4500) or to receive an implantable loop recorder with continuous remote monitoring (n=1500) and initiation of OAC if AF is detected.

The primary endpoint is time to first stroke or systemic arterial embolism. The trial is event-driven and planned to continue until 279 adjudicated primary events have occurred.

Sub-studies include AF characterization, health economic analyses, quality-of-life assessments, cognitive function assessments, and studies of risk markers from 12-lead ECG, genetics, cardiac and brain imaging, biochemistry, and more.

Study Type

Interventional

Enrollment (Actual)

6000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 90 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 70-90 years, and

  • Previously diagnosed with ≥1 of:

    • Diabetes mellitus (type 1 or type 2, with or without medical therapy)
    • Hypertension (with or without medical therapy)
    • Heart failure
    • Previous diagnosed stroke (previous transient ischemic attack is not considered an inclusion criterion)

Exclusion Criteria:

  • History of atrial fibrillation or flutter irrespective of type
  • Cardiac pacemaker or defibrillator (with or without re-synchronization therapy)
  • Contraindication to oral anticoagulation therapy
  • Anticoagulation therapy; vitamin K antagonists, direct oral anticoagulants, or (low-molecular) heparins. Therapy with platelet inhibitors such as acetyl-salicylic acid, clopidogrel, persantine is not considered an exclusion criterion
  • Renal failure treated with permanent dialysis
  • Uncorrected congenital heart disease, or severe valvular stenosis, obstructive cardiomyopathy, active myocarditis, or constrictive pericarditis.
  • On a waiting list for major surgery (cardiac, thoracic or abdominal)
  • Cardiac or thoracic surgery has been performed within 3 months from inclusion
  • Any major organ transplant (e.g. lung, liver, heart, or kidney)
  • Cytotoxic or cytostatic chemotherapy and/or radiation therapy for treatment of a malignancy within 6 months before randomization or clinical evidence of current malignancy with the following exceptions: Basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, prostate cancer (if stable, localized disease with a life expectancy of > 2.5 years in the opinion of the investigator)
  • Life-expectancy shorter than 6 months
  • Known to be human immunodeficiency virus (HIV) positive with an expected survival of less than 5 years due to HIV infection
  • Recent (within 3 months) history of alcohol or drug abuse based on self-reporting
  • Any condition (e.g. psychiatric illness, dementia) or situation, that in the investigators opinion could put the subject at significant risk, confound the study results, or interfere significantly with the subject participation in the study
  • Unwillingness to participate or patient does not understand Danish language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ILR group
Receive implantable loop recorder (ILR, Medtronic Reveal LINQ(TM)) with continuous monitoring, and will be followed by daily automated remote transmissions. Study visits are scheduled annually until the 4th visit, and furthermore, endpoints are collected via lookup in medical records and registries on at least an annual basis until the finalization of the trial.
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.
No Intervention: Control group
Followed according to standard care, i.e. by their general practitioner. Study visits are scheduled at inclusion and after 3 years. Furthermore, the participants are contacted by telephone after 1 and 2 years of follow-up, and endpoints are collected via lookup in medical records and registries on at least an annual basis until the finalization of the trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to adjudicated stroke or systemic arterial embolism
Time Frame: At the completion of the event-driven trial, expected 4 years

Time to the first of one of the components of the combined primary endpoint

  • adjudicated stroke, or
  • adjudicated systemic arterial embolism
At the completion of the event-driven trial, expected 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to adjudicated ischemic stroke/transient ischemic attack/systemic arterial embolism
Time Frame: At the completion of the event-driven trial, expected 4 years

Time to the first of one of the components of the combined endpoint

  • adjudicated ischemic stroke, or
  • adjudicated transient ischemic attack, or
  • adjudicated systemic arterial embolism
At the completion of the event-driven trial, expected 4 years
Time to adjudicated stroke, or systemic arterial embolism, or cardiovascular death
Time Frame: At the completion of the event-driven trial, expected 4 years

Time to the first of one of the components of the combined endpoint

  • adjudicated stroke, or
  • adjudicated systemic arterial embolism, or
  • adjudicated cardiovascular death
At the completion of the event-driven trial, expected 4 years
Time to adjudicated cardiovascular death
Time Frame: At the completion of the event-driven trial, expected 4 years
At the completion of the event-driven trial, expected 4 years
Time to death by any cause
Time Frame: At the completion of the event-driven trial, expected 4 years
At the completion of the event-driven trial, expected 4 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to diagnosis of AF
Time Frame: At the completion of the event-driven trial, expected 4 years
At the completion of the event-driven trial, expected 4 years
Time to initiation of OAC
Time Frame: At the completion of the event-driven trial, expected 4 years
At the completion of the event-driven trial, expected 4 years
Time to adjudicated intracranial hemorrhage not classified as stroke
Time Frame: At the completion of the event-driven trial, expected 4 years
At the completion of the event-driven trial, expected 4 years
Time to adjudicated hemorrhagic stroke
Time Frame: At the completion of the event-driven trial, expected 4 years
At the completion of the event-driven trial, expected 4 years
Time to major bleeding as defined by the International Society on Thrombosis and Haemostasis criteria
Time Frame: At the completion of the event-driven trial, expected 4 years
At the completion of the event-driven trial, expected 4 years
Presence of complications related to loop recorder implantation; infection, hematoma, or other complication related to device implantation requiring intervention
Time Frame: During implantable loop recorder monitoring, expected 3 years
During implantable loop recorder monitoring, expected 3 years
Change from baseline in quality of life
Time Frame: 3 years (from baseline to the at the fourth study visit)
Quality of life assessed with the "EuroQol, 5 Dimensions with 5 Levels" instrument (EQ-5D-5L) with range 5-25 and higher values indicating higher quality of life.
3 years (from baseline to the at the fourth study visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Odense University Hospital
Zealand University Hospital
Bispebjerg Hospital
University of Southern Denmark
Aalborg University

Investigators

  • Principal Investigator: Jesper H Svendsen, MD, DMSc, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

February 1, 2020

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

January 8, 2014

First Submitted That Met QC Criteria

January 14, 2014

First Posted (Estimate)

January 15, 2014

Study Record Updates

Last Update Posted (Actual)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-4-2013-025
  • 13-135225 (Other Grant/Funding Number: Danish Strategic Research Council)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Implantable loop recorder (Medtronic Reveal LINQ(TM))

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe