Comparing LAA closure and anticoagulation for atrial fibrillation patients after brain bleeding

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial compares two treatment options for patients with atrial fibrillation who have experienced an intracranial bleed. It evaluates the effectiveness of left atrial appendage (LAA) closure versus oral anticoagulation therapy in preventing strokes. The study involves a randomized approach, using already approved drugs and devices, to assess the safety and efficacy of these interventions. The goal is to generate data that could inform clinical guidelines for managing these high-risk patients.

Why it matters

Who can join: the full rules

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's running

• University Hospital Mannheim
  Mannheim, Baden-Wurttemberg, Germany Recruiting
• RHÖN-KLINIKUM Campus Bad Neustadt
  Bad Neustadt an der Saale, Bavaria, Germany Recruiting
• REGIOMED Klinikum Coburg
  Coburg, Bavaria, Germany Recruiting
• Universitätsklinikum Erlangen
  Erlangen, Bavaria, Germany Recruiting
• Klinikum Ingolstadt
  Ingolstadt, Bavaria, Germany Recruiting
• Städtisches Klinikum Brandenburg GmbH
  Brandenburg an der Havel, Brandenburg, Germany Recruiting

Study contacts

• Principal investigator: Sven Möbius-Winkler, Prof. Dr. — Department of Internal Medicine I, Jena University Hospital
• Study coordinator: Sven Möbius-Winkler, Prof. Dr.
• Email: sven.moebius-winkler@med.uni-jena.de
• Phone: +4936419324503

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.