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

NCT04298723

RecruitingNA

Sponsor: Jena University Hospital

Conditions: Intracranial Hemorrhages, Atrial Fibrillation (AF), Atrial Flutter

Interventions: Percutaneous closure of the LAA (Watchman / Watchman FLX)

Countries: Germany, Poland

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (39)
  • Mannheim, Baden-Wurttemberg, Germany
  • Bad Neustadt an der Saale, Bavaria, Germany
  • Burgau, Bavaria, Germany
  • Coburg, Bavaria, Germany
  • Erlangen, Bavaria, Germany
  • Ingolstadt, Bavaria, Germany
  • Rosenheim, Bavaria, Germany
  • Brandenburg an der Havel, Brandenburg, Germany
  • Hamburg, Free and Hanseatic City of Hamburg, Germany
  • Hamburg, Free and Hanseatic City of Hamburg, Germany
  • Hamburg, Free and Hanseatic City of Hamburg, Germany
  • Hamburg, Free and Hanseatic City of Hamburg, Germany
  • Hamburg, Free and Hanseatic City of Hamburg, Germany
  • Frankfurt am Main, Hesse, Germany
  • Rotenburg an der Fulda, Hesse, Germany
  • Rüsselsheim am Main, Hesse, Germany
  • Bielefeld, North Rhine-Westphalia, Germany
  • Dortmund, North Rhine-Westphalia, Germany
  • Dortmund, North Rhine-Westphalia, Germany
  • Recklinghausen, North Rhine-Westphalia, Germany
  • Kaiserslautern, Rhineland-Palatinate, Germany
  • Koblenz, Rhineland-Palatinate, Germany
  • Chemnitz, Saxony, Germany
  • Dresden, Saxony, Germany
  • Leipzig, Saxony, Germany
  • Leipzig, Saxony, Germany
  • Leipzig, Saxony, Germany
  • Pirna, Saxony, Germany
  • Zwickau, Saxony, Germany
  • Halle, Saxony-Anhalt, Germany
  • + 9 more on CT.gov