Comparing LAA closure and anticoagulation for atrial fibrillation patients after brain 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.
This study is testing whether closing a part of the heart or using blood thinners is better for preventing strokes in patients with atrial fibrillation who have had a brain bleed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 530 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jena University Hospital Academic / other |
| Locations | 33 sites (Mannheim, Baden-Wurttemberg and 32 other locations) |
| Trial ID | NCT04298723 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with documented atrial fibrillation and a history of intracranial bleeding more than six weeks prior.
Not a fit: Patients with significant comorbidities requiring ongoing anticoagulation therapy or those with active infections or severe liver failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer treatment option that reduces the risk of bleeding while effectively preventing strokes in patients with atrial fibrillation.
How similar studies have performed: While there is existing evidence supporting both treatment approaches, this specific comparison in patients post-intracranial bleeding is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Mannheim, Baden-Wurttemberg and 32 other locations
- University Hospital Mannheim — Mannheim, Baden-Wurttemberg, Germany (Recruiting)
- RHÖN-KLINIKUM Campus Bad Neustadt — Bad Neustadt an der Saale, Bavaria, Germany (Active_not_recruiting)
- Therapiezentrum Burgau — Burgau, Bavaria, Germany (Active_not_recruiting)
- REGIOMED Klinikum Coburg — Coburg, Bavaria, Germany (Recruiting)
- Universitätsklinikum Erlangen — Erlangen, Bavaria, Germany (Recruiting)
- Klinikum Ingolstadt — Ingolstadt, Bavaria, Germany (Recruiting)
- RoMed Klinikum — Rosenheim, Bavaria, Germany (Active_not_recruiting)
- Cardiologicum Hamburg — Hamburg, Free and Hanseatic City of Hamburg, Germany (Recruiting)
- Asklepios Klinik Wandsbek — Hamburg, Free and Hanseatic City of Hamburg, Germany (Recruiting)
- Asklepios Klinik Nord Heidberg — Hamburg, Free and Hanseatic City of Hamburg, Germany (Recruiting)
- Asklepios Klinik Altona — Hamburg, Free and Hanseatic City of Hamburg, Germany (Recruiting)
- Herz-Kreislauf-Zentrum — Rotenburg an der Fulda, Hesse, Germany (Active_not_recruiting)
- Evangelisches Klinikum Bethel — Bielefeld, North Rhine-Westphalia, Germany (Recruiting)
- Klinikum Dortmund — Dortmund, North Rhine-Westphalia, Germany (Active_not_recruiting)
- Knappschaft Kliniken — Dortmund, North Rhine-Westphalia, Germany (Recruiting)
- Westpfalz-Klinikum — Kaiserslautern, Rhineland-Palatinate, Germany (Recruiting)
- Katholisches Klinikum Koblenz • Montabaur — Koblenz, Rhineland-Palatinate, Germany (Recruiting)
- Klinikum Chemnitz — Chemnitz, Saxony, Germany (Recruiting)
- Dresden Heart Center — Dresden, Saxony, Germany (Recruiting)
- University Hospital Leipzig — Leipzig, Saxony, Germany (Recruiting)
- Klinikum St. Georg — Leipzig, Saxony, Germany (Recruiting)
- Heart Center Leipzig — Leipzig, Saxony, Germany (Recruiting)
- Helios Klinikum Pirna — Pirna, Saxony, Germany (Recruiting)
- Heinrich-Braun-Klinikum (HBK) — Zwickau, Saxony, Germany (Recruiting)
- University Hospital Magdeburg — Magdeburg, Saxony-Anhalt, Germany (Recruiting)
- Universitätsklinikum Schleswig-Holstein (UKSH) — Lübeck, Schleswig-Holstein, Germany (Recruiting)
- Charité - Universitätsmedizin Berlin (CBF) — Berlin, State of Berlin, Germany (Recruiting)
- Charité - Universitätsmedizin Berlin (CVK — Berlin, State of Berlin, Germany (Active_not_recruiting)
- Helios Klinikum Erfurt — Erfurt, Thuringia, Germany (Recruiting)
- University Hospital Jena — Jena, Thuringia, Germany (Recruiting)
- Uniwersytecki Szpital Kliniczny w Poznaniu — Poznan, Greater Poland Voivodeship, Poland (Not_yet_recruiting)
- Polsko-Amerykańskie Kliniki Serca — Bielsko-Biala, Silesian Voivodeship, Poland (Not_yet_recruiting)
- Górnośląskim Centrum Medycznym — Katowice, Silesian Voivodeship, Poland (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.