Comparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding.
Recruiting · NCT04298723 · Interventional (participants receive a specific treatment) · Lead sponsor: Jena University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Percutaneous closure of the LAA (Watchman / Watchman FLX)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
39 locations listed.
- University Hospital Mannheim - Mannheim, Baden-Wurttemberg, Germany
- RHÖN-KLINIKUM Campus Bad Neustadt - Bad Neustadt an der Saale, Bavaria, Germany
- Therapiezentrum Burgau - Burgau, Bavaria, Germany
- REGIOMED Klinikum Coburg - Coburg, Bavaria, Germany
- Universitätsklinikum Erlangen - Erlangen, Bavaria, Germany
- Klinikum Ingolstadt - Ingolstadt, Bavaria, Germany
- RoMed Klinikum - Rosenheim, Bavaria, Germany
- Städtisches Klinikum Brandenburg GmbH - Brandenburg an der Havel, Brandenburg, Germany
- Cardiologicum Hamburg - Hamburg, Free and Hanseatic City of Hamburg, Germany
- Asklepios Klinik Wandsbek - Hamburg, Free and Hanseatic City of Hamburg, Germany
- Katholisches Marienkrankenhaus gGmbH - Hamburg, Free and Hanseatic City of Hamburg, Germany
- Asklepios Klinik Nord Heidberg - Hamburg, Free and Hanseatic City of Hamburg, Germany
- Asklepios Klinik Altona - Hamburg, Free and Hanseatic City of Hamburg, Germany
- Uniwersytecki Szpital Kliniczny w Poznaniu - Poznan, Greater Poland Voivodeship, Poland
- Universitätsklinikum der J.W. Goethe-Universität Frankfurt - Frankfurt am Main, Hesse, Germany
- Herz-Kreislauf-Zentrum - Rotenburg an der Fulda, Hesse, Germany
- GPR Gesundheits- und Pflegezentrum Rüsselsheim - Rüsselsheim am Main, Hesse, Germany
- Evangelisches Klinikum Bethel - Bielefeld, North Rhine-Westphalia, Germany
- Klinikum Dortmund - Dortmund, North Rhine-Westphalia, Germany
- Knappschaft Kliniken - Dortmund, North Rhine-Westphalia, Germany
- Klinikum Vest GmbH Recklinghausen - Recklinghausen, North Rhine-Westphalia, Germany
- Westpfalz-Klinikum - Kaiserslautern, Rhineland-Palatinate, Germany
- Katholisches Klinikum Koblenz • Montabaur - Koblenz, Rhineland-Palatinate, Germany
- Klinikum Chemnitz - Chemnitz, Saxony, Germany
- Dresden Heart Center - Dresden, Saxony, Germany
- University Hospital Leipzig - Leipzig, Saxony, Germany
- Klinikum St. Georg - Leipzig, Saxony, Germany
- Heart Center Leipzig - Leipzig, Saxony, Germany
- Helios Klinikum Pirna - Pirna, Saxony, Germany
- Heinrich-Braun-Klinikum (HBK) - Zwickau, Saxony, Germany
- Universitätsklinikum Halle (Saale) - Halle, Saxony-Anhalt, Germany
- University Hospital Magdeburg - Magdeburg, Saxony-Anhalt, Germany
- Universitätsklinikum Schleswig-Holstein (UKSH) - Lübeck, Schleswig-Holstein, Germany
- Polsko-Amerykańskie Kliniki Serca - Bielsko-Biala, Silesian Voivodeship, Poland
- Górnośląskim Centrum Medycznym - Katowice, Silesian Voivodeship, Poland
- Charité - Universitätsmedizin Berlin (CBF) - Berlin, State of Berlin, Germany
- Charité - Universitätsmedizin Berlin (CVK - Berlin, State of Berlin, Germany
- Helios Klinikum Erfurt - Erfurt, Thuringia, Germany
- University Hospital Jena - Jena, Thuringia, Germany