Atrial FibrillationLOOPNCT02036450
Atrial Fibrillation Detected by Continuous ECG Monitoring
A study testing Implantable loop recorder (Medtronic Reveal LINQ(TM)) in people with Atrial Fibrillation and Stroke, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 to 90 years
- Conditions the study is for
- Atrial Fibrillation, Stroke, Hypertension
- What is being tested?
- Implantable loop recorder (Medtronic Reveal LINQ(TM))
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2014to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation, Stroke, Hypertension, Diabetes
- Being tested
- Implantable loop recorder (Medtronic Reveal LINQ(TM))
- Keywords
- atrial fibrillation, cardiac arrhythmia, stroke, implantable loop recorder, bleeding, anticoagulation, hypertension, diabetes, heart failure, mortality
- Medical subject headings
- Atrial Fibrillation, Stroke, Hypertension, Diabetes Mellitus, Arrhythmias, Cardiac, Hemorrhage, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| ILR group | Experimental | 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. Receives: Device: Implantable loop recorder (Medtronic Reveal LINQ(TM)) |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Time to adjudicated stroke or systemic arterial embolism
Time to the first of one of the components of the combined primary endpoint
- adjudicated stroke, or
- adjudicated systemic arterial embolism
Measured: At the completion of the event-driven trial, expected 4 years
Secondary outcomes (4)
Time to adjudicated ischemic stroke/transient ischemic attack/systemic arterial embolism
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
Measured: At the completion of the event-driven trial, expected 4 years
Time to adjudicated stroke, or systemic arterial embolism, or cardiovascular death
Time to the first of one of the components of the combined endpoint
- adjudicated stroke, or
- adjudicated systemic arterial embolism, or
- adjudicated cardiovascular death
Measured: At the completion of the event-driven trial, expected 4 years
Time to adjudicated cardiovascular death
Measured: At the completion of the event-driven trial, expected 4 years
Time to death by any cause
Measured: At the completion of the event-driven trial, expected 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionFeb 2020
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital, Zealand University Hospital, Odense University Hospital, University of Southern Denmark, Aalborg University
- Responsible party
- Principal investigator, Jesper Hastrup Svendsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Jesper H Svendsen, MD, DMSc, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036450
- Sponsor's protocol ID
- H-4-2013-025
- Other IDs
- 13-135225
- Acronym
- LOOP
- Status last verified
- Mar 2021
- First submitted
- 8 Jan 2014
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Healey JS, Connolly SJ, Gold MR, Israel CW, Van Gelder IC, Capucci A, Lau CP, Fain E, Yang S, Bailleul C, Morillo CA, Carlson M, Themeles E, Kaufman ES, Hohnloser SH; ASSERT Investigators. Subclinical atrial fibrillation and the risk of stroke. N Engl J Med. 2012 Jan 12;366(2):120-9. doi: 10.1056/NEJMoa1105575.
PubMed 22236222Brachmann J, Morillo CA, Sanna T, Di Lazzaro V, Diener HC, Bernstein RA, Rymer M, Ziegler PD, Liu S, Passman RS. Uncovering Atrial Fibrillation Beyond Short-Term Monitoring in Cryptogenic Stroke Patients: Three-Year Results From the Cryptogenic Stroke and Underlying Atrial Fibrillation Trial. Circ Arrhythm Electrophysiol. 2016 Jan;9(1):e003333. doi: 10.1161/CIRCEP.115.003333.
PubMed 26763225Marini C, De Santis F, Sacco S, Russo T, Olivieri L, Totaro R, Carolei A. Contribution of atrial fibrillation to incidence and outcome of ischemic stroke: results from a population-based study. Stroke. 2005 Jun;36(6):1115-9. doi: 10.1161/01.STR.0000166053.83476.4a. Epub 2005 May 5.
PubMed 15879330Heidenreich PA, Trogdon JG, Khavjou OA, Butler J, Dracup K, Ezekowitz MD, Finkelstein EA, Hong Y, Johnston SC, Khera A, Lloyd-Jones DM, Nelson SA, Nichol G, Orenstein D, Wilson PW, Woo YJ; American Heart Association Advocacy Coordinating Committee; Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Arteriosclerosis; Thrombosis and Vascular Biology; Council on Cardiopulmonary; Critical Care; Perioperative and Resuscitation; Council on Cardiovascular Nursing; Council on the Kidney in Cardiovascular Disease; Council on Cardiovascular Surgery and Anesthesia, and Interdisciplinary Council on Quality of Care and Outcomes Research. Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association. Circulation. 2011 Mar 1;123(8):933-44. doi: 10.1161/CIR.0b013e31820a55f5. Epub 2011 Jan 24.
PubMed 21262990Hessellund AK, Haugan KJ, Xing LY, Kongebro EK, Vad OB, Graff C, Spona DC, Baadsgaard JA, Andersen A, Haedersdal S, Truelsen T, Hojberg S, Brandes A, Kober L, Frikke-Schmidt R, Svendsen JH, Diederichsen SZ. Glycaemic variation and atrial fibrillation burden and progression in individuals without diabetes undergoing continuous rhythm monitoring. Int J Cardiol. 2026 Aug 13:134727. doi: 10.1016/j.ijcard.2026.134727. Online ahead of print.
PubMed 42595184Hessellund AK, Kongebro EK, Haugan KJ, Xing LY, Vad OB, Graff C, Spona DC, Baadsgaard JA, Hojberg S, Brandes A, Kober L, Frikke-Schmidt R, Svendsen JH, Diederichsen SZ. Inflammation and day-to-day occurrence of atrial fibrillation. Europace. 2026 Mar 30;28(4):euag067. doi: 10.1093/europace/euag067.
PubMed 41964166Kongebro EK, Kronborg C, Haugan KJ, Graff C, Hojberg S, Krieger D, Brandes A, Kober L, Svendsen JH, Diederichsen SZ. The impact of screening-detected atrial fibrillation and associated outcomes on quality of life. Qual Life Res. 2025 Dec;34(12):3597-3608. doi: 10.1007/s11136-025-04047-1. Epub 2025 Aug 31.
PubMed 40886243Xing LY, Hojberg S, Kriegerg DW, Graff C, Olesen MS, Healey JS, McIntyre WF, Brandes A, Kober L, Haugan KJ, Svendsen JH, Diederichsen SZ. Heart Failure Events After Long-term Continuous Screening for Atrial Fibrillation: Results From the Randomized LOOP Study. Circ Arrhythm Electrophysiol. 2024 Aug;17(8):e012764. doi: 10.1161/CIRCEP.124.012764. Epub 2024 Jul 18.
PubMed 39022823Olsen FJ, Diederichsen SZ, Jorgensen PG, Jensen MT, Dahl A, Landler NE, Graff C, Brandes A, Krieger D, Haugan K, Kober L, Hojberg S, Svendsen JH, Biering-Sorensen T. Left Atrial Strain Predicts Subclinical Atrial Fibrillation Detected by Long-term Continuous Monitoring in Elderly High-Risk Individuals. Circ Cardiovasc Imaging. 2024 Mar;17(3):e016197. doi: 10.1161/CIRCIMAGING.123.016197. Epub 2024 Mar 5.
PubMed 38440875Xing LY, Diederichsen SZ, Hojberg S, Krieger DW, Graff C, Frikke-Schmidt R, Platonov PG, Olesen MS, Brandes A, Kober L, Haugan KJ, Svendsen JH. The ABC-Stroke Risk Score and Effects of Atrial Fibrillation Screening on Stroke Prevention: Results From the Randomized LOOP Study. J Am Heart Assoc. 2024 Feb 20;13(4):e032744. doi: 10.1161/JAHA.123.032744. Epub 2024 Feb 14.
PubMed 38353260Xing LY, Diederichsen SZ, Hojberg S, Krieger DW, Graff C, Frikke-Schmidt R, Olesen MS, Brandes A, Kober L, Haugan KJ, Svendsen JH. Effects of Atrial Fibrillation Screening According to N-Terminal Pro-B-Type Natriuretic Peptide: A Secondary Analysis of the Randomized LOOP Study. Circulation. 2023 Jun 13;147(24):1788-1797. doi: 10.1161/CIRCULATIONAHA.123.064361. Epub 2023 Apr 15.
PubMed 37061802Diederichsen SZ, Frederiksen KS, Xing LY, Haugan KJ, Hojberg S, Brandes A, Graff C, Olesen MS, Krieger D, Kober L, Svendsen JH. Severity and Etiology of Incident Stroke in Patients Screened for Atrial Fibrillation vs Usual Care and the Impact of Prior Stroke: A Post Hoc Analysis of the LOOP Randomized Clinical Trial. JAMA Neurol. 2022 Oct 1;79(10):997-1004. doi: 10.1001/jamaneurol.2022.3031.
PubMed 36036546Xing LY, Diederichsen SZ, Hojberg S, Krieger DW, Graff C, Olesen MS, Brandes A, Kober L, Haugan KJ, Svendsen JH. Systolic Blood Pressure and Effects of Screening for Atrial Fibrillation With Long-Term Continuous Monitoring (a LOOP Substudy). Hypertension. 2022 Sep;79(9):2081-2090. doi: 10.1161/HYPERTENSIONAHA.122.19333. Epub 2022 Jul 8.
PubMed 35862138Bonnesen MP, Frodi DM, Haugan KJ, Kronborg C, Graff C, Hojberg S, Kober L, Krieger D, Brandes A, Svendsen JH, Diederichsen SZ. Day-to-day measurement of physical activity and risk of atrial fibrillation. Eur Heart J. 2021 Oct 7;42(38):3979-3988. doi: 10.1093/eurheartj/ehab597.
PubMed 34471928Svendsen JH, Diederichsen SZ, Hojberg S, Krieger DW, Graff C, Kronborg C, Olesen MS, Nielsen JB, Holst AG, Brandes A, Haugan KJ, Kober L. Implantable loop recorder detection of atrial fibrillation to prevent stroke (The LOOP Study): a randomised controlled trial. Lancet. 2021 Oct 23;398(10310):1507-1516. doi: 10.1016/S0140-6736(21)01698-6. Epub 2021 Aug 29.
PubMed 34469766
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation Detected by Continuous ECG Monitoring Using Implantable Loop Recorder to Prevent Stroke in High-risk Individuals.
- ClinicalTrials.gov ID
- NCT02036450
- Acronym / sponsor ID
- LOOP / H-4-2013-025
- Conditions
- Atrial Fibrillation, Stroke, Hypertension, Diabetes
- Keywords
- atrial fibrillation, cardiac arrhythmia, stroke, implantable loop recorder, bleeding, anticoagulation, hypertension, diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,000 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital, Zealand University Hospital, Odense University Hospital, University of Southern Denmark, Aalborg University
- Study start
- Jan 2014
- Primary completion
- Feb 2020 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 15 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ILR group | Experimental | Device: Implantable loop recorder (Medtronic Reveal LINQ(TM))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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 70 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age 70-90 years, and
- Previously diagnosed with ≥1 of:
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | ILR group |
Primary outcome
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
4 secondary outcomes
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 adjudicated stroke, or systemic arterial embolism, or cardiovascular death
Time frame: 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
Time to death by any cause
Time frame: At the completion of the event-driven trial, expected 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Background: PubMed 22236222Healey JS, Connolly SJ, Gold MR, Israel CW, Van Gelder IC, Capucci A, Lau CP, Fain E, Yang S, Bailleul C, Morillo CA, Carlson M, Themeles E, Kaufman ES, Hohnloser SH; ASSERT Investigators. Subclinical atrial fibrillation and the risk of stroke. N Engl J Med. 2012 Jan 12;366(2):120-9. doi: 10.1056/NEJMoa1105575.
- Background: PubMed 26763225Brachmann J, Morillo CA, Sanna T, Di Lazzaro V, Diener HC, Bernstein RA, Rymer M, Ziegler PD, Liu S, Passman RS. Uncovering Atrial Fibrillation Beyond Short-Term Monitoring in Cryptogenic Stroke Patients: Three-Year Results From the Cryptogenic Stroke and Underlying Atrial Fibrillation Trial. Circ Arrhythm Electrophysiol. 2016 Jan;9(1):e003333. doi: 10.1161/CIRCEP.115.003333.
- Background: PubMed 15879330Marini C, De Santis F, Sacco S, Russo T, Olivieri L, Totaro R, Carolei A. Contribution of atrial fibrillation to incidence and outcome of ischemic stroke: results from a population-based study. Stroke. 2005 Jun;36(6):1115-9. doi: 10.1161/01.STR.0000166053.83476.4a. Epub 2005 May 5.
- Background: PubMed 21262990Heidenreich PA, Trogdon JG, Khavjou OA, Butler J, Dracup K, Ezekowitz MD, Finkelstein EA, Hong Y, Johnston SC, Khera A, Lloyd-Jones DM, Nelson SA, Nichol G, Orenstein D, Wilson PW, Woo YJ; American Heart Association Advocacy Coordinating Committee; Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Arteriosclerosis; Thrombosis and Vascular Biology; Council on Cardiopulmonary; Critical Care; Perioperative and Resuscitation; Council on Cardiovascular Nursing; Council on the Kidney in Cardiovascular Disease; Council on Cardiovascular Surgery and Anesthesia, and Interdisciplinary Council on Quality of Care and Outcomes Research. Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association. Circulation. 2011 Mar 1;123(8):933-44. doi: 10.1161/CIR.0b013e31820a55f5. Epub 2011 Jan 24.
- Derived from this study: PubMed 42595184Hessellund AK, Haugan KJ, Xing LY, Kongebro EK, Vad OB, Graff C, Spona DC, Baadsgaard JA, Andersen A, Haedersdal S, Truelsen T, Hojberg S, Brandes A, Kober L, Frikke-Schmidt R, Svendsen JH, Diederichsen SZ. Glycaemic variation and atrial fibrillation burden and progression in individuals without diabetes undergoing continuous rhythm monitoring. Int J Cardiol. 2026 Aug 13:134727. doi: 10.1016/j.ijcard.2026.134727. Online ahead of print.
- Derived from this study: PubMed 41964166Hessellund AK, Kongebro EK, Haugan KJ, Xing LY, Vad OB, Graff C, Spona DC, Baadsgaard JA, Hojberg S, Brandes A, Kober L, Frikke-Schmidt R, Svendsen JH, Diederichsen SZ. Inflammation and day-to-day occurrence of atrial fibrillation. Europace. 2026 Mar 30;28(4):euag067. doi: 10.1093/europace/euag067.
- Derived from this study: PubMed 40886243Kongebro EK, Kronborg C, Haugan KJ, Graff C, Hojberg S, Krieger D, Brandes A, Kober L, Svendsen JH, Diederichsen SZ. The impact of screening-detected atrial fibrillation and associated outcomes on quality of life. Qual Life Res. 2025 Dec;34(12):3597-3608. doi: 10.1007/s11136-025-04047-1. Epub 2025 Aug 31.
- Derived from this study: PubMed 39022823Xing LY, Hojberg S, Kriegerg DW, Graff C, Olesen MS, Healey JS, McIntyre WF, Brandes A, Kober L, Haugan KJ, Svendsen JH, Diederichsen SZ. Heart Failure Events After Long-term Continuous Screening for Atrial Fibrillation: Results From the Randomized LOOP Study. Circ Arrhythm Electrophysiol. 2024 Aug;17(8):e012764. doi: 10.1161/CIRCEP.124.012764. Epub 2024 Jul 18.
- Derived from this study: PubMed 38440875Olsen FJ, Diederichsen SZ, Jorgensen PG, Jensen MT, Dahl A, Landler NE, Graff C, Brandes A, Krieger D, Haugan K, Kober L, Hojberg S, Svendsen JH, Biering-Sorensen T. Left Atrial Strain Predicts Subclinical Atrial Fibrillation Detected by Long-term Continuous Monitoring in Elderly High-Risk Individuals. Circ Cardiovasc Imaging. 2024 Mar;17(3):e016197. doi: 10.1161/CIRCIMAGING.123.016197. Epub 2024 Mar 5.
- Derived from this study: PubMed 38353260Xing LY, Diederichsen SZ, Hojberg S, Krieger DW, Graff C, Frikke-Schmidt R, Platonov PG, Olesen MS, Brandes A, Kober L, Haugan KJ, Svendsen JH. The ABC-Stroke Risk Score and Effects of Atrial Fibrillation Screening on Stroke Prevention: Results From the Randomized LOOP Study. J Am Heart Assoc. 2024 Feb 20;13(4):e032744. doi: 10.1161/JAHA.123.032744. Epub 2024 Feb 14.
- Derived from this study: PubMed 37061802Xing LY, Diederichsen SZ, Hojberg S, Krieger DW, Graff C, Frikke-Schmidt R, Olesen MS, Brandes A, Kober L, Haugan KJ, Svendsen JH. Effects of Atrial Fibrillation Screening According to N-Terminal Pro-B-Type Natriuretic Peptide: A Secondary Analysis of the Randomized LOOP Study. Circulation. 2023 Jun 13;147(24):1788-1797. doi: 10.1161/CIRCULATIONAHA.123.064361. Epub 2023 Apr 15.
- Derived from this study: PubMed 36036546Diederichsen SZ, Frederiksen KS, Xing LY, Haugan KJ, Hojberg S, Brandes A, Graff C, Olesen MS, Krieger D, Kober L, Svendsen JH. Severity and Etiology of Incident Stroke in Patients Screened for Atrial Fibrillation vs Usual Care and the Impact of Prior Stroke: A Post Hoc Analysis of the LOOP Randomized Clinical Trial. JAMA Neurol. 2022 Oct 1;79(10):997-1004. doi: 10.1001/jamaneurol.2022.3031.
- Homepage for the LOOP studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesper H Svendsen, MD, DMSc principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable loop recorder (Medtronic Reveal LINQ(TM)) in people with Atrial Fibrillation and Stroke, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to adjudicated stroke or systemic arterial embolism (time frame: At the completion of the event-driven trial, expected 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02036450, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.