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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy

RecruitingNAAges 18 Years - anyAllInsel Gruppe AG, University Hospital Bern
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In plain words

What the trial is, and whether it could suit you

Atrial fibrillation (AF) is one of the most common cardiac arrhythmias and cardioembolic stroke due to AF is its major complication. Direct oral anticoagulants (DOAC) reduce the risk of cardioembolism in patients with AF. Despite DOAC therapy, there is a significant residual stroke risk of 1-2%/year. Recent data from the Swiss Stroke Registry found 38% of patients with AF and ischemic stroke were on prior anticoagulant therapy (approximately 400 patients per year in Switzerland). The investigators found in a prior observational study, that patients with AF who have ischemic stroke despite anticoagulation are at increased risk of having another ischemic stroke (HR 1.6; 95% confidence interval, CI 1.1-2.1). Combining observational data from 11 international stroke centres, the investigators found that the majority of ischemic strokes despite anticoagulation in patients with AF is "breakthr

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

📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years * Written informed consent * Permanent, persistent, or paroxysmal spontaneous AF previously known or diagnosed during the index hospitalization. * Recent (≤3 months) symptomatic ischemic stroke. * Active and ongoing anticoagulation therapy at stroke onset assessed based on medical history (i.e. any therapeutic oral anticoagulation therapy \[Vitamin K antagonist/DOAC according to prescription recommendations for AF; inadequate low-dose DOAC therapy allowed for inclusion\] not stopped/paused for \>48 hours due to any reason, i.e. medical intervention or non-adherence). * Active or planned long-term therapy with DOAC Exclusion Criteria: * Contraindications to DOAC therapy * Life expectancy \<1 year according to the opinion of the investigator * Stroke due to: Ipsilateral intra/extracranial high-grade stenosis, Isolated lacunar stroke, Other well-defined stroke aetiologies (i.e., endocarditis, vasculitis, Reversible Cerebral Vasoconstriction Syndrome \[RCVS\], Posterior Reversible Encephalopathy Syndrome \[PRES\], cerebral sinus venous thrombosis) * Previous persistent foramen ovale or atrial septum defect closure. * Rheumatic heart disease * Severe heart valve disease that requires treatment (severe aortic stenosis or regurgitation, severe mitral stenosis or regurgitation). * Contraindications for TEE (relevant esophageal varices, esophageal stricture, history of esophageal cancer). * Cardiac or non-cardiac surgical procedure within 30 days of randomization * Enrolled in another investigation of a cardiovascular device or investigating secondary prevention therapy. * Severely reduced Left Ventricular Ejection Fraction (LVEF) \<30%. * Severe renal impairment as described in the summary of medicinal product characteristics for the chosen DOAC (e.g. rivaroxaban, apixaban and edoxaban creatinine clearance \<15 ml/min; dabigatran creatinine clearance \<30 ml/min). * Hypertrophic cardiomyopathy * Intracardiac tumor * Ventricular thrombus * Acute cardiac decompensation * LAA is obliterated or surgically ligated * Persistent proximal LAA thrombus despite 4 weeks of anticoagulation (if a proximal thrombus in the LAA is found, anticoagulation with vitamin K antagonist (INR 2.5-3.5) may be started, and if the thrombus disappears, the patient may be eligible for LAAO) * Pregnancy or breastfeeding (pregnancy test in urine or blood to be performed at screening for women of childbearing potential)
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What it tests

  • Left atrial appendage Occlusion
  • DOAC
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Where

32 sites
AZ Sint Jan Brugge
Bruges, Belgium
Brussels University Hospital
Brussels, Belgium
UCLouvain - Cliniques universitaires Saint-Luc
Brussels, Belgium
HUmani CHU Charleroi-Chimay
Charleroi, Belgium
Universitair Ziekenhuis (UZ) Leuven
Leuven, Belgium
CHU Liège Sart-Tilman
Liège, Belgium
UKSH, Campus Lübeck
Lübeck, Germany
Charité-Universitätsmedizin Berlin
Berlin, Germany

…and 24 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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