NCT07713615Recruiting
Blood Clotting Markers and Heart Ultrasound in People With Device-Detected Atrial Fibrillation
Device-Detected Atrial Fibrillation - Haemostatic Profile and Echocardiographic Variables
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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 since the last device interrogation. 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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 222 (estimated)
- First submitted
- 8 Jul 2026
- Start date
- 27 Feb 2026
- Primary completion date
- 28 Feb 2029
- Lead sponsor
- Andreas Sjøholm-Christensen
- Diseases
- Stroke, Atrial fibrillation
- NCT number
- NCT07713615
What you commit to
- Study type: Observational
- Planned participants: 222
- From 27 Feb 2026 to the primary completion date, 28 Feb 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Major surgery within the last 3 months
- Acute coronary syndrome, stroke/transient ischemic attack, or venous thromboembolism within 3 months prior to inclusion
Other illness
- Active malignancy, defined as cancer diagnosis not followed by curative treatment within 6 months of diagnosis
- Connective tissue disease requiring treatment
- 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
Lab values
- End-stage renal disease (creatinine clearance \<15 mL/min, calculated using the Cockcroft-Gault equation)
Other
- Pregnancy or breastfeeding
- Known thrombophilia
Who the study is looking for
- Age \> 50 years at inclusion
- Presence of a cardiac implanted electronic device, either:
- A pacemaker or internal cardiac defibrillator with an atrial lead
- An implantable cardiac monitor
- ≥1 episode of device-detected atrial fibrillation lasting ≥30 seconds within the previous 12 months, indentified:
- During routine cardiac implantable electronic device interrogation for patients with a pacemaker or implantable cardiac defibrillator.
- Through remote monitoring for patients with an implantable cardiac monitor
- The longest episode of device-detected atrial fibrillation must be confirmed by the investigator by review of the stored intracardiac electrogram (EGM) for pacemakers and implantable cardiac defibrillators or review of the single-lead electrogardiogram for implantable cardiac monitors.
- Written informed consent obtained prior to inclusion
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Cardiology, Esbjerg and Grindsted Hospital, Southwest Denmark Coordinator of this site? Confirm its status | Esbjerg | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.