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.

Status: Recruiting
Location: See all (33) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
RHÖN-KLINIKUM Campus Bad Neustadt
ACTIVE_NOT_RECRUITING
Bad Neustadt An Der Saale
Charité - Universitätsmedizin Berlin (CBF)
RECRUITING
Berlin
Charité - Universitätsmedizin Berlin (CVK
ACTIVE_NOT_RECRUITING
Berlin
Evangelisches Klinikum Bethel
RECRUITING
Bielefeld
Therapiezentrum Burgau
ACTIVE_NOT_RECRUITING
Burgau
Klinikum Chemnitz
RECRUITING
Chemnitz
REGIOMED Klinikum Coburg
RECRUITING
Coburg
Klinikum Dortmund
ACTIVE_NOT_RECRUITING
Dortmund
Knappschaft Kliniken
RECRUITING
Dortmund
Dresden Heart Center
RECRUITING
Dresden
Helios Klinikum Erfurt
RECRUITING
Erfurt
Universitätsklinikum Erlangen
RECRUITING
Erlangen
Asklepios Klinik Altona
RECRUITING
Hamburg
Asklepios Klinik Nord Heidberg
RECRUITING
Hamburg
Asklepios Klinik Wandsbek
RECRUITING
Hamburg
Cardiologicum Hamburg
RECRUITING
Hamburg
Klinikum Ingolstadt
RECRUITING
Ingolstadt
University Hospital Jena
RECRUITING
Jena
Westpfalz-Klinikum
RECRUITING
Kaiserslautern
Katholisches Klinikum Koblenz • Montabaur
RECRUITING
Koblenz
Heart Center Leipzig
RECRUITING
Leipzig
Klinikum St. Georg
RECRUITING
Leipzig
University Hospital Leipzig
RECRUITING
Leipzig
Universitätsklinikum Schleswig-Holstein (UKSH)
RECRUITING
Lübeck
University Hospital Magdeburg
RECRUITING
Magdeburg
University Hospital Mannheim
RECRUITING
Mannheim
Helios Klinikum Pirna
RECRUITING
Pirna
RoMed Klinikum
ACTIVE_NOT_RECRUITING
Rosenheim
Herz-Kreislauf-Zentrum
ACTIVE_NOT_RECRUITING
Rotenburg An Der Fulda
Heinrich-Braun-Klinikum (HBK)
RECRUITING
Zwickau
Poland
Polsko-Amerykańskie Kliniki Serca
NOT_YET_RECRUITING
Bielsko-biala
Górnośląskim Centrum Medycznym
RECRUITING
Katowice
Uniwersytecki Szpital Kliniczny w Poznaniu
NOT_YET_RECRUITING
Poznan
Contact Information
Primary
Sven Möbius-Winkler, Prof. Dr.
sven.moebius-winkler@med.uni-jena.de
+4936419324503
Backup
Marcus Winter
marcus.winter@med.uni-jena.de
+4936419396648
Time Frame
Start Date: 2020-06-16
Estimated Completion Date: 2029-12
Participants
Target number of participants: 530
Treatments
Experimental: Left Atrial Appendage Occlusion
Percutaneous closure of the LAA by use of CE-mark approved LAA occlusion device Watchman / Watchman FLX
No_intervention: Best Medical Therapy for Anticoagulation
Standard of care (according to current guidelines)
Authors
Sven Möbius- Winkler, Albrecht Günther
Related Therapeutic Areas
Sponsors
Collaborators: KCRI
Leads: Jena University Hospital

This content was sourced from clinicaltrials.gov