Blood Clotting Markers and Heart Ultrasound in People With Device-Detected Atrial Fibrillation

NCT07713615 | Recruiting

• 1 other identifier: 116655
• Study Type: observational
• Target: 222
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this observational study is to investigate whether blood tests related to blood clotting are associated with established clinical stroke risk scores, the total amount of device-detected atrial fibrillation recorded by an implanted cardiac device, and ultrasound measurements of the heart in people with device-detected atrial fibrillation. The study will also evaluate whether these baseline measurements are associated with future clinical outcomes and may improve future stroke risk assessment. Device-detected atrial fibrillation is an irregular heart rhythm detected by implanted cardiac devices such as pacemakers, implantable cardiac monitors, and implantable defibrillators. It is often brief and does not cause symptoms. Although it increases the risk of stroke and systemic embolism, the risk is lower than in people with clinically diagnosed atrial fibrillation. As a result, it remains difficult to identify which patients are most likely to benefit from blood-thinning medication, which reduces the risk of stroke but also increases the risk of bleeding. The study will include 222 participants with implanted cardiac devices, including 111 participants with device-detected atrial fibrillation and 111 age-, sex-, and cardiac device indication-matched control participants without device-detected atrial fibrillation. At baseline, participants will undergo blood sampling, ultrasound examination of the heart, and routine device interrogation. Information on medical history and established clinical stroke risk factors will also be collected. The implanted cardiac device will be used to determine the total amount of device-detected atrial fibrillation recorded during the year before study inclusion. The baseline analyses will investigate whether established clinical stroke risk scores, the total amount of device-detected atrial fibrillation, and heart ultrasound findings are associated with changes in blood clotting that may indicate an increased tendency to form blood clots. The study will evaluate both primary and additional blood clotting markers to improve the understanding of the biological mechanisms underlying thromboembolic risk in device-detected atrial fibrillation. Participants will subsequently be followed for 10 years to determine whether baseline blood clotting markers, the total amount of device-detected atrial fibrillation, heart ultrasound findings, and clinical stroke risk scores are associated with future clinical outcomes, including stroke, systemic embolism, hospitalization, death, progression to clinically diagnosed atrial fibrillation, and initiation of oral anticoagulant therapy. The findings may improve the understanding of thromboembolic risk in people with device-detected atrial fibrillation and support the development of more individualized approaches to future stroke risk assessment and treatment.

Conditions

Device-detected Atrial Fibrillation; Subclinical Atrial Fibrillation; Atrial High Rate Episodes

Keywords

Stroke risk; Thromboembolism; ABC-stroke score; Haemostasis; Thrombin generation; von Willebrand factor; Echocardiography; Left atrial function; Cardiac implantable electronic devices; Oral anticoagulation; Biomarkers; Atrial fibrillation burden; CHA₂DS₂-VASc; CHA₂DS₂-VA

Outcome Measures

Primary Outcomes (2)

• Thrombin generation assessed by endogenous thrombin potential

  Thrombin generation plays a pivotal role in blood clotting and thus serve as primary outcome measure. Thrombin generation will be assessed through measurement of endogenous thrombin potential (nmol/L x min), using the calibrated automated thrombography (CAT) method.

  Baseline

• Levels of von Willebrand factor (vWF) antigen

  von Willebrand factor plays an important role in platelet plug formation. von Willebrand factor antigen (%) will be measured using an in-house immunoassay.

  Baseline

Secondary Outcomes (50)

• Plasma P-selectin Concentration

  Baseline

• Thrombin generation assessed by lag time

  Baseline.

• Thrombin generation assessed by peak thrombin concentration

  Baseline

• Thrombin generation assessed by time to peak

  Baseline

• Kallikrein generation assessed by lag time

  Baseline

Study Arms (2)

Device-detected atrial fibrillation

Patients with implanted cardiac devices with at least one episode of device-detected atrial fibrillation lasting ≥ 1 minute within the preceding year, identified during routine device interrogation visits.

Matched controls without device-detected atrial fibrillation

Patients with implanted cardiac devices without device-detected atrial fibrillation in the preceding four years, matched 1:1 to cases on age, sex, and indication for device implantation, identified during routine device follow-up visits.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will be recruited from the Department of Cardiology, Esbjerg and Grindsted Hospital, University Hospital of Southern Denmark. The study population comprises adults with implanted cardiac devices undergoing routine outpatient device interrogation. The device-detected atrial fibrillation cohort will include participants with at least one episode of device-detected atrial fibrillation lasting ≥1 minute identified during routine device interrogation within the previous 12 months. The control cohort will comprise participants without device-detected atrial fibrillation during the previous 4 years, recruited from the same outpatient population and matched on age, sex, and indication for cardiac device implantation. All participants will be enrolled consecutively from a single-center cardiology outpatient clinic.

You may qualify if:

• Implanted cardiac device with an atrial electrode
• ≥1 episode of device-detected atrial fibrillation lasting ≥1 minute, detected at routine cardiac device interrogation within the last 12 months

You may not qualify if:

• Current treatment with oral contraceptives or hormone replacement therapy
• Pregnancy or breastfeeding
• End-stage renal disease (creatinine clearance \<15 mL/min, calculated using the Cockcroft-Gault equation)
• Active malignancy, defined as cancer diagnosis not followed by curative treatment within 6 months of diagnosis
• Major surgery within the last 3 months
• Connective tissue disease requiring treatment
• Known thrombophilia
• Clinically significant hepatic or hematological disease requiring treatment and/or specialist follow-up
• Mechanical heart valve, moderate-to-severe mitral stenosis, or other valvular disease requiring intervention

Sponsors & Collaborators

• Andreas Sjøholm-Christensen: lead
• Sydvestjysk Kardiologisk Fond: collaborator
• Grosserer L.F. Foghts Foundation: collaborator
• Region of Southern Denmark: collaborator
• Karola Jørgensens Foundation and Foundation for Cardiology in Southwest Denmark.: collaborator
• The Simon Spies Foundation: collaborator
• The foundation of Fam. Kjærsgaard, Sunds: collaborator
• The A.P. Moeller Foundation: collaborator
• OPEN, Open Patient data Explorative Network, Odense University Hospital, Region of Southern Denmark: collaborator

Study Sites (1)

Department of Cardiology, Esbjerg and Grindsted Hospital, Southwest Denmark

Esbjerg, 6700, Denmark

RECRUITING

Related Publications (19)

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  PMID: 31625555 BACKGROUND

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  PMID: 37956458 BACKGROUND

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• Van Gelder IC, Healey JS, Crijns HJGM, Wang J, Hohnloser SH, Gold MR, Capucci A, Lau CP, Morillo CA, Hobbelt AH, Rienstra M, Connolly SJ. Duration of device-detected subclinical atrial fibrillation and occurrence of stroke in ASSERT. Eur Heart J. 2017 May 1;38(17):1339-1344. doi: 10.1093/eurheartj/ehx042.

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• McIntyre WF, Benz AP, Becher N, Healey JS, Granger CB, Rivard L, Camm AJ, Goette A, Zapf A, Alings M, Connolly SJ, Kirchhof P, Lopes RD. Direct Oral Anticoagulants for Stroke Prevention in Patients With Device-Detected Atrial Fibrillation: A Study-Level Meta-Analysis of the NOAH-AFNET 6 and ARTESiA Trials. Circulation. 2024 Mar 26;149(13):981-988. doi: 10.1161/CIRCULATIONAHA.123.067512. Epub 2023 Nov 12.

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• Schnabel RB, Benezet-Mazuecos J, Becher N, McIntyre WF, Fierenz A, Lee SF, Goette A, Atar D, Bertaglia E, Benz AP, Chlouverakis G, Birnie DH, Dichtl W, Blomstrom-Lundqvist C, Camm AJ, Erath JW, Simantirakis E, Kutyifa V, Lip GYH, Mabo P, Marijon E, Rivard L, Schotten U, Alings M, Sehner S, Toennis T, Linde C, Vardas P, Granger CB, Zapf A, Lopes RD, Healey JS, Kirchhof P. Anticoagulation in device-detected atrial fibrillation with or without vascular disease: a combined analysis of the NOAH-AFNET 6 and ARTESiA trials. Eur Heart J. 2024 Dec 7;45(46):4902-4916. doi: 10.1093/eurheartj/ehae596.

  PMID: 39222018 BACKGROUND

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum Plasma (citrated plasma)

MeSH Terms

Conditions

Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Andreas Sjøholm-Christensen, MD

  Region of Southern Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Sjøholm-Christensen, MD

CONTACT

+45 71776422; andreas.sjoholm-christensen@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD Student

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 20, 2026
• Study Start: February 27, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): September 1, 2037
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)