Actively Recruiting
Comparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding.
Led by Jena University Hospital · Updated on 2025-09-02
530
Participants Needed
33
Research Sites
493 weeks
Total Duration
On this page
Sponsors
J
Jena University Hospital
Lead Sponsor
K
KCRI
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Comparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent
- Documented atrial fibrillation (paroxysmal, persistent, long-standing persistent or permanent)
- CHA2DS2VASc-Score 2
- Status post intracranial bleeding more than 6 weeks ago
- Favorable left atrial appendage anatomy
- Eligible for a left atrial appendage occluder device
- Age 18 years or older
You will not qualify if you...
- Other medical conditions requiring chronic oral anticoagulation, such as mechanical heart valve or hereditary thrombophilia
- Untreated symptomatic carotid artery disease
- Blood clot in the left atrium or left atrial appendage
- Active infection or active endocarditis
- Severe functional impairment (modified ranking scale 4 or higher)
- Severe liver failure (Child-Pugh class C) or liver failure with blood clotting problems
- Pregnancy or breastfeeding
- Participation in another interventional clinical trial within 30 days before this study
- Life expectancy less than 1 year, including end-stage heart failure
- Legally committed to an institution by court order
- Planned cardiac or non-cardiac surgery or intervention (can join 30 days after procedure)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 33 locations
1
University Hospital Mannheim
Mannheim, Baden-Wurttemberg, Germany, 68167
Actively Recruiting
2
RHÖN-KLINIKUM Campus Bad Neustadt
Bad Neustadt an der Saale, Bavaria, Germany, 97616
Active, Not Recruiting
3
Therapiezentrum Burgau
Burgau, Bavaria, Germany, 89331
Active, Not Recruiting
4
REGIOMED Klinikum Coburg
Coburg, Bavaria, Germany, 96450
Actively Recruiting
5
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany, 91054
Actively Recruiting
6
Klinikum Ingolstadt
Ingolstadt, Bavaria, Germany, 85049
Actively Recruiting
7
RoMed Klinikum
Rosenheim, Bavaria, Germany, 83022
Active, Not Recruiting
8
Cardiologicum Hamburg
Hamburg, Free and Hanseatic City of Hamburg, Germany, 22041
Actively Recruiting
9
Asklepios Klinik Wandsbek
Hamburg, Free and Hanseatic City of Hamburg, Germany, 22043
Actively Recruiting
10
Asklepios Klinik Nord Heidberg
Hamburg, Free and Hanseatic City of Hamburg, Germany, 22417
Actively Recruiting
11
Asklepios Klinik Altona
Hamburg, Free and Hanseatic City of Hamburg, Germany, 22763
Actively Recruiting
12
Herz-Kreislauf-Zentrum
Rotenburg an der Fulda, Hesse, Germany, 44137
Active, Not Recruiting
13
Evangelisches Klinikum Bethel
Bielefeld, North Rhine-Westphalia, Germany, 33617
Actively Recruiting
14
Klinikum Dortmund
Dortmund, North Rhine-Westphalia, Germany, 44137
Active, Not Recruiting
15
Knappschaft Kliniken
Dortmund, North Rhine-Westphalia, Germany, 44309
Actively Recruiting
16
Westpfalz-Klinikum
Kaiserslautern, Rhineland-Palatinate, Germany, 67655
Actively Recruiting
17
Katholisches Klinikum Koblenz • Montabaur
Koblenz, Rhineland-Palatinate, Germany, 56073
Actively Recruiting
18
Klinikum Chemnitz
Chemnitz, Saxony, Germany, 09113
Actively Recruiting
19
Dresden Heart Center
Dresden, Saxony, Germany, 01307
Actively Recruiting
20
University Hospital Leipzig
Leipzig, Saxony, Germany, 04103
Actively Recruiting
21
Klinikum St. Georg
Leipzig, Saxony, Germany, 04129
Actively Recruiting
22
Heart Center Leipzig
Leipzig, Saxony, Germany, 04289
Actively Recruiting
23
Helios Klinikum Pirna
Pirna, Saxony, Germany, 01796
Actively Recruiting
24
Heinrich-Braun-Klinikum (HBK)
Zwickau, Saxony, Germany, 08060
Actively Recruiting
25
University Hospital Magdeburg
Magdeburg, Saxony-Anhalt, Germany, 68167
Actively Recruiting
26
Universitätsklinikum Schleswig-Holstein (UKSH)
Lübeck, Schleswig-Holstein, Germany, 23538
Actively Recruiting
27
Charité - Universitätsmedizin Berlin (CBF)
Berlin, State of Berlin, Germany, 12203
Actively Recruiting
28
Charité - Universitätsmedizin Berlin (CVK
Berlin, State of Berlin, Germany, 13353
Active, Not Recruiting
29
Helios Klinikum Erfurt
Erfurt, Thuringia, Germany, 99089
Actively Recruiting
30
University Hospital Jena
Jena, Thuringia, Germany, 07747
Actively Recruiting
31
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Greater Poland Voivodeship, Poland, 61-848
Not Yet Recruiting
32
Polsko-Amerykańskie Kliniki Serca
Bielsko-Biala, Silesian Voivodeship, Poland, 43-316
Not Yet Recruiting
33
Górnośląskim Centrum Medycznym
Katowice, Silesian Voivodeship, Poland, 40-635
Actively Recruiting
Research Team
S
Sven Möbius-Winkler, Prof. Dr.
CONTACT
M
Marcus Winter
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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