Comparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding.
Key facts
- Where
- Bad Neustadt an der Saale, Berlin, Bielefeld, Brandenburg an der Havel, Burgau, Chemnitz, Coburg, Dortmund, Dresden, Erfurt, Erlangen, Frankfurt am Main, Halle, Hamburg, Ingolstadt, Jena, Kaiserslautern, Koblenz, Leipzig, Lübeck, Magdeburg, Mannheim, Pirna, Recklinghausen, Rosenheim, Rotenburg an der Fulda, Rüsselsheim am Main, and Zwickau, GermanySee the 36 sites
Where in Germany
- RHÖN-KLINIKUM Campus Bad NeustadtBad Neustadt an der Saale, GermanyTaking people
- Charité - Universitätsmedizin Berlin (CBF)Berlin, GermanyTaking people
- Charité - Universitätsmedizin Berlin (CVK)Berlin, GermanyNo longer taking part
- Evangelisches Klinikum BethelBielefeld, GermanyTaking people
- Städtisches Klinikum Brandenburg GmbHBrandenburg an der Havel, GermanyTaking people
- Therapiezentrum BurgauBurgau, GermanyNo longer taking part
- Klinikum ChemnitzChemnitz, GermanyTaking people
- Regiomed Klinikum CoburgCoburg, GermanyTaking people
- Knappschaft KlinikenDortmund, GermanyTaking people
- Klinikum DortmundDortmund, GermanyNo longer taking part
- Dresden Heart CenterDresden, GermanyTaking people
- Helios Klinikum ErfurtErfurt, GermanyTaking people
- Universitätsklinikum ErlangenErlangen, GermanyTaking people
- Universitätsklinikum der J.W. Goethe-Universität FrankfurtFrankfurt am Main, GermanyNot yet recruiting
- Universitätsklinikum Halle (Saale)Halle, GermanyNo longer taking part
- Asklepios Klinik AltonaHamburg, GermanyTaking people
- Asklepios Klinik Nord - HeidbergHamburg, GermanyTaking people
- Asklepios Klinik WandsbekHamburg, GermanyTaking people
- Cardiologicum HamburgHamburg, GermanyTaking people
- Katholisches Marienkrankenhaus gGmbHHamburg, GermanyTaking people
- Klinikum IngolstadtIngolstadt, GermanyTaking people
- University Hospital JenaJena, GermanyTaking people
- Westpfalz- KlinikumKaiserslautern, GermanyTaking people
- Katholisches Klinikum Koblenz • MontabaurKoblenz, GermanyTaking people
- Heart Center LeipzigLeipzig, GermanyTaking people
- Klinikum St. GeorgLeipzig, GermanyTaking people
- University Hospital LeipzigLeipzig, GermanyTaking people
- Universitätsklinikum Schleswig-Holstein (UKSH)Lübeck, GermanyTaking people
- University Hospital MagdeburgMagdeburg, GermanyTaking people
- University Hospital MannheimMannheim, GermanyTaking people
- Helios Klinikum PirnaPirna, GermanyTaking people
- Klinikum Vest GmbH RecklinghausenRecklinghausen, GermanyNo longer taking part
- RoMed KlinikumRosenheim, GermanyNo longer taking part
- Herz-Kreislauf-ZentrumRotenburg an der Fulda, GermanyNo longer taking part
- GPR Gesundheits- und Pflegezentrum RüsselsheimRüsselsheim am Main, GermanyTaking people
- Heinrich-Braun-Klinikum (HBK)Zwickau, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jena University Hospital
- Trial code
- NCT04298723
- Record updated
- 6 August 2026
- Original description
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.Read full original descriptionShow less
Randomized Comparison of Interventional Closure of the Left Atrial Appendage Using a LAA Closure Device Versus Oral Anticoagulation Therapy in Patients With Non-valvular Atrial Fibrillation and Status Post Intracranial Bleeding.
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.
Inclusion: 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: Subject with participation in another interventional clinical trial during this study or within 30 days before entry into this trial; 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); 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); Known terminating disease with life expectancy <1 year (including those with end-stage heart failure); Subjects with planned cardiac or non-cardiac surgery or intervention. (These subjects can be included 30 days after intervention / surgery; Thrombus in the left atrium or left atrial appendage; Pregnancy or breastfeeding; Subjects, who are committed to an institution due to binding official or court order.