NCT04298723Recruiting
Comparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding.
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.
Source: ClinicalTrials.gov · Last updated 6 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 530 (estimated)
- First submitted
- 1 Mar 2020
- Start date
- 16 Jun 2020
- Primary completion date
- Jun 2029
- Lead sponsor
- Jena University Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT04298723
What you commit to
- Study type: Interventional
- Planned participants: 530
- From 16 Jun 2020 to the primary completion date, Jun 2029
- 39 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subject with participation in another interventional clinical trial during this study or within 30 days before entry into this trial.
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (39)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| RHÖN-KLINIKUM Campus Bad Neustadt Coordinator of this site? Confirm its status | Bad Neustadt an der Saale | Germany | Recruiting |
| Charité - Universitätsmedizin Berlin (CBF) Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Charité - Universitätsmedizin Berlin (CVK) Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Evangelisches Klinikum Bethel Coordinator of this site? Confirm its status | Bielefeld | Germany | Recruiting |
| Städtisches Klinikum Brandenburg GmbH Coordinator of this site? Confirm its status | Brandenburg an der Havel | Germany | Recruiting |
| Therapiezentrum Burgau Coordinator of this site? Confirm its status | Burgau | Germany | Active, not recruiting |
| Klinikum Chemnitz Coordinator of this site? Confirm its status | Chemnitz | Germany | Recruiting |
| Regiomed Klinikum Coburg Coordinator of this site? Confirm its status | Coburg | Germany | Recruiting |
| Knappschaft Kliniken Coordinator of this site? Confirm its status | Dortmund | Germany | Recruiting |
| Klinikum Dortmund Coordinator of this site? Confirm its status | Dortmund | Germany | Active, not recruiting |
| Dresden Heart Center Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| Helios Klinikum Erfurt Coordinator of this site? Confirm its status | Erfurt | Germany | Recruiting |
| Universitätsklinikum Erlangen Coordinator of this site? Confirm its status | Erlangen | Germany | Recruiting |
| Universitätsklinikum der J.W. Goethe-Universität Frankfurt Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Not yet recruiting |
| Universitätsklinikum Halle (Saale) Coordinator of this site? Confirm its status | Halle | Germany | Active, not recruiting |
| Asklepios Klinik Altona Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Cardiologicum Hamburg Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Asklepios Klinik Nord - Heidberg Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Asklepios Klinik Wandsbek Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Katholisches Marienkrankenhaus gGmbH Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Klinikum Ingolstadt Coordinator of this site? Confirm its status | Ingolstadt | Germany | Recruiting |
| University Hospital Jena Coordinator of this site? Confirm its status | Jena | Germany | Recruiting |
| Westpfalz- Klinikum Coordinator of this site? Confirm its status | Kaiserslautern | Germany | Recruiting |
| Katholisches Klinikum Koblenz • Montabaur Coordinator of this site? Confirm its status | Koblenz | Germany | Recruiting |
| Klinikum St. Georg Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| University Hospital Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| Heart Center Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| Universitätsklinikum Schleswig-Holstein (UKSH) Coordinator of this site? Confirm its status | Lübeck | Germany | Recruiting |
| University Hospital Magdeburg Coordinator of this site? Confirm its status | Magdeburg | Germany | Recruiting |
| University Hospital Mannheim Coordinator of this site? Confirm its status | Mannheim | Germany | Recruiting |
| Helios Klinikum Pirna Coordinator of this site? Confirm its status | Pirna | Germany | Recruiting |
| Klinikum Vest GmbH Recklinghausen Coordinator of this site? Confirm its status | Recklinghausen | Germany | Active, not recruiting |
| RoMed Klinikum Coordinator of this site? Confirm its status | Rosenheim | Germany | Active, not recruiting |
| Herz-Kreislauf-Zentrum Coordinator of this site? Confirm its status | Rotenburg an der Fulda | Germany | Active, not recruiting |
| GPR Gesundheits- und Pflegezentrum Rüsselsheim Coordinator of this site? Confirm its status | Rüsselsheim am Main | Germany | Recruiting |
| Heinrich-Braun-Klinikum (HBK) Coordinator of this site? Confirm its status | Zwickau | Germany | Recruiting |
| Polsko-Amerykanskie Kliniki Serca Coordinator of this site? Confirm its status | Bielsko-Biala | Poland | Not yet recruiting |
| Górnośląskim Centrum Medycznym Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.