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Comparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding.

RecruitingNAAges 18 Years - anyAllJena University Hospital
NCT04298723 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Atrial fibrillation is the most common cardiac arrhythmia. In atrial fibrillation, there is a risk that clots can form in the heart, especially in the left atrium. If these clots come loose, there is a risk of stroke. To prevent strokes, patients with atrial fibrillation and status post ICB can be treated with anticoagulants. This medication therapy prevents blood clots from forming in the heart, but can also cause bleeding. Another therapy option is the occlusion of the left atrium. After closure of the left atrium, only a short anticoagulation therapy is necessary until the occluder has healed. The aim of the study is to compare these two treatment approaches. In this study only already approved drugs and occlusion systems will be used.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Signed written informed consent * Documented atrial fibrillation (paroxysmal, persistent, long-standing persistent or permanent) * CHA2DS2VASc-Score ≥2 * Status post intracranial bleeding \>6 weeks * Favorable LAA anatomy * Subject eligible for a LAA occluder device * Age ≥18 years Exclusion Criteria: * Comorbidities other than AF requiring chronic (N)OAC therapy, e.g. mechanical heart valve prosthesis, hereditary thrombophilia requiring livelong OAC - recurrent thrombosis * Symptomatic carotid disease (if not treated) * Thrombus in the left atrium or left atrial appendage * Active infection or active endocarditis or other infections resulting in bacteremia * Functional Impairment (modified ranking scale ≥4 ) * Severe liver failure (Child-Pugh class C or liver failure with coagulopathy) * Pregnancy or breastfeeding * Subject with participation in another interventional clinical trial during this study or within 30 days before entry into this trial. * Known terminating disease with life expectancy \<1 year (including those with end-stage heart failure) * Subjects, who are committed to an institution due to binding official or court order * Subjects with planned cardiac or non-cardiac surgery or intervention. (These subjects can be included 30 days after intervention / surgery
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What it tests

  • Percutaneous closure of the LAA (Watchman / Watchman FLX)
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Where

39 sites
University Hospital Mannheim
Mannheim, Germany
RHÖN-KLINIKUM Campus Bad Neustadt
Bad Neustadt an der Saale, Germany
Therapiezentrum Burgau
Burgau, Germany
REGIOMED Klinikum Coburg
Coburg, Germany
Universitätsklinikum Erlangen
Erlangen, Germany
Klinikum Ingolstadt
Ingolstadt, Germany
RoMed Klinikum
Rosenheim, Germany
Städtisches Klinikum Brandenburg GmbH
Brandenburg an der Havel, Germany

…and 31 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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