Blood Clotting Markers and Heart Ultrasound in People With Device-Detected Atrial Fibrillation
Recruiting now
Conditions studied: Device-detected Atrial Fibrillation, Subclinical Atrial Fibrillation, Atrial High Rate Episodes
In brief
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.
Key facts
- Study ID
- NCT07713615
- Run by
- Andreas Sjøholm-Christensen
- People needed
- 222
- Starts
- 2026-02-27
- Expected to finish
- 2037-09-01
- Last updated by the study team
- 2026-07-20
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age > 50 years at inclusion
- 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
- Written informed consent obtained prior to inclusion
You may not qualify if…
- History of ECG-documented atrial fibrillation at any time prior to inclusion
- Use of oral anticoagulation or dual antiplatelet therapy within 6 months prior to inclusion, irrespective of indication
- 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
- Acute coronary syndrome, stroke/transient ischemic attack, or venous thromboembolism within 3 months prior to inclusion
- 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
Where it is running
- Department of Cardiology, Esbjerg and Grindsted Hospital, Southwest Denmark — Esbjerg, Denmark (enrolling)
Full record on ClinicalTrials.gov
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