Comparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding.
Launched by JENA UNIVERSITY HOSPITAL · Mar 5, 2020
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two ways to help prevent strokes in patients with atrial fibrillation (AF) who have experienced an intracranial bleed (bleeding in the brain). One option is to use blood-thinning medications called anticoagulants, which help prevent clots but can also increase the risk of bleeding. The other option is a procedure that closes off a part of the heart called the left atrial appendage (LAA), which can also reduce the risk of clots. The goal of the study is to see which treatment is more effective and safe for these patients.
To participate in the trial, you need to be at least 18 years old, have a history of atrial fibrillation, and have had an intracranial bleed at least six weeks ago. You should also be able to use a device that closes off the left atrial appendage. If you meet these criteria, you may be eligible to join the study. Participants will receive either the anticoagulant therapy or the LAA closure procedure, and the study will monitor their progress over time. It's important to know that all the treatments used in the trial are already approved for use.
Gender
ALL
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
About Jena University Hospital
Jena University Hospital is a leading academic medical center located in Jena, Germany, renowned for its commitment to advancing healthcare through innovative research and high-quality clinical care. As a prominent sponsor of clinical trials, the hospital leverages its multidisciplinary expertise and state-of-the-art facilities to conduct rigorous studies aimed at evaluating new treatments, medical devices, and healthcare interventions. With a strong focus on collaboration between clinicians, researchers, and academic partners, Jena University Hospital plays a pivotal role in translating scientific discoveries into tangible benefits for patients, ultimately enhancing the quality of medical practice and public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Erlangen, , Germany
Erfurt, , Germany
Minden, , Germany
Gera, , Germany
Leipzig, , Germany
Hamburg, , Germany
Magdeburg, , Germany
Rostock, , Germany
Leipzig, Sachsen, Germany
Ingolstadt, , Germany
Kaiserslautern, , Germany
Hamburg, , Germany
Hamburg, , Germany
Hamburg, , Germany
Berlin, , Germany
Gera, Thüringen, Germany
Recklinghausen, , Germany
Coburg, , Germany
Freiburg, Baden Württemberg, Germany
Friedrichshafen, Baden Wurttemberg, Germany
Frankfurt Am Main, Hessen, Germany
Bottrop, Nordrhein Westfahlen, Germany
Quedlinburg, Sachsen Anhalt, Germany
Chemnitz, Sachsen, Germany
Dresden, Sachsen, Germany
Zwickau, Sachsen, Germany
Erfurt, Thüringen, Germany
Bad Neustadt An Der Saale, , Germany
Bielefeld, , Germany
Dresden, , Germany
Essen, , Germany
Frankfurt, , Germany
Hamburg Nord, , Germany
Hamburg, , Germany
Homburg/Saar, , Germany
Jena, , Germany
Leipzig, , Germany
Leipzig, , Germany
Mannheim, , Germany
Montabaur, , Germany
Pirna, , Germany
Dortmund, , Germany
Hamburg, , Germany
Kiel, , Germany
Lübeck, , Germany
Neuwied, , Germany
Freiburg, , Germany
Erfurt, , Germany
Patients applied
Trial Officials
Sven Möbius-Winkler, Univ. Prof.
Principal Investigator
Department of Internal Medicine I, Jena University Hospital
Albrecht Günther, Dr. med.
Principal Investigator
Department of Neurology, Jena University Hospital
Albrecht Waschke, PD Dr. med.
Principal Investigator
Department of Neurosurgery, RHÖN-KLINIKUM Campus Bad Neustadt
P. Christian Schulze, Prof. Dr.
Principal Investigator
Department of Internal Medicine I, Jena University Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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