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โ† Trials
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Blood Clotting Markers and Heart Ultrasound in People With Device-Detected Atrial Fibrillation

Recruitingn/aAges 50 Years - anyAllAndreas Sjรธholm-Christensen
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 * โ‰ฅ1 episode of device-detected atrial fibrillation lasting โ‰ฅ30 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
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What it tests

  • Not listed
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Where

1 site
Department of Cardiology, Esbjerg and Grindsted Hospital, Southwest Denmark
Esbjerg, Denmark
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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