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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
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

Full criteria on ClinicalTrials.gov

Sites (39)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
RHÖN-KLINIKUM Campus Bad Neustadt
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Bad Neustadt an der SaaleGermanyRecruiting
Charité - Universitätsmedizin Berlin (CBF)
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BerlinGermanyRecruiting
Charité - Universitätsmedizin Berlin (CVK)
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BerlinGermanyActive, not recruiting
Evangelisches Klinikum Bethel
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BielefeldGermanyRecruiting
Städtisches Klinikum Brandenburg GmbH
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Brandenburg an der HavelGermanyRecruiting
Therapiezentrum Burgau
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BurgauGermanyActive, not recruiting
Klinikum Chemnitz
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ChemnitzGermanyRecruiting
Regiomed Klinikum Coburg
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CoburgGermanyRecruiting
Knappschaft Kliniken
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DortmundGermanyRecruiting
Klinikum Dortmund
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DortmundGermanyActive, not recruiting
Dresden Heart Center
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DresdenGermanyRecruiting
Helios Klinikum Erfurt
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ErfurtGermanyRecruiting
Universitätsklinikum Erlangen
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ErlangenGermanyRecruiting
Universitätsklinikum der J.W. Goethe-Universität Frankfurt
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Frankfurt am MainGermanyNot yet recruiting
Universitätsklinikum Halle (Saale)
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HalleGermanyActive, not recruiting
Asklepios Klinik Altona
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HamburgGermanyRecruiting
Cardiologicum Hamburg
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HamburgGermanyRecruiting
Asklepios Klinik Nord - Heidberg
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HamburgGermanyRecruiting
Asklepios Klinik Wandsbek
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HamburgGermanyRecruiting
Katholisches Marienkrankenhaus gGmbH
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HamburgGermanyRecruiting
Klinikum Ingolstadt
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IngolstadtGermanyRecruiting
University Hospital Jena
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JenaGermanyRecruiting
Westpfalz- Klinikum
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KaiserslauternGermanyRecruiting
Katholisches Klinikum Koblenz • Montabaur
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KoblenzGermanyRecruiting
Klinikum St. Georg
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LeipzigGermanyRecruiting
University Hospital Leipzig
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LeipzigGermanyRecruiting
Heart Center Leipzig
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LeipzigGermanyRecruiting
Universitätsklinikum Schleswig-Holstein (UKSH)
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LübeckGermanyRecruiting
University Hospital Magdeburg
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MagdeburgGermanyRecruiting
University Hospital Mannheim
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MannheimGermanyRecruiting
Helios Klinikum Pirna
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PirnaGermanyRecruiting
Klinikum Vest GmbH Recklinghausen
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RecklinghausenGermanyActive, not recruiting
RoMed Klinikum
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RosenheimGermanyActive, not recruiting
Herz-Kreislauf-Zentrum
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Rotenburg an der FuldaGermanyActive, not recruiting
GPR Gesundheits- und Pflegezentrum Rüsselsheim
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Rüsselsheim am MainGermanyRecruiting
Heinrich-Braun-Klinikum (HBK)
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ZwickauGermanyRecruiting
Polsko-Amerykanskie Kliniki Serca
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Bielsko-BialaPolandNot yet recruiting
Górnośląskim Centrum Medycznym
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KatowicePolandRecruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.