Blood clotting markers and heart imaging in people with device-detected atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort study follows adults with implanted heart devices who have device-detected atrial fibrillation (DDAF) to see how blood coagulation markers, stroke risk scores, and heart imaging relate to future outcomes. It collects baseline blood tests related to haemostasis, device-recorded AF burden, and echocardiographic measures, then tracks participants for up to 10 years to see if these factors improve stroke risk prediction. Conducted at Esbjerg and Grindsted Hospitals in Denmark, the study enrolls 222 participants aged over 50 and analyzes three baseline analyses before longitudinal follow-up. The aim is to determine whether integrating biomarkers, AF burden, and echocardiographic markers can refine risk stratification for stroke and thromboembolism in DDAF patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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's running

• Department of Cardiology, Esbjerg and Grindsted Hospital, Southwest Denmark
  Esbjerg, Denmark Recruiting

Study contacts

• Principal investigator: Andreas Sjøholm-Christensen, MD — Region of Southern Denmark
• Study coordinator: Andreas Sjøholm-Christensen, MD
• Email: andreas.sjoholm-christensen@rsyd.dk
• Phone: +45 71776422

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.