Status:
RECRUITING
Comparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding.
Lead Sponsor:
Jena University Hospital
Collaborating Sponsors:
KCRI
Conditions:
Intracranial Hemorrhages
Atrial Fibrillation (AF)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
Within the current trial, two novel strategies are tested in a randomized fashion in patients with atrial fibrillation and status post intracranial bleeding. Patients with ICH were usually excluded fr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
530 Patients enrolled
Trial Details
Trial ID
NCT04298723
Start Date
June 16 2020
End Date
December 1 2029
Last Update
September 2 2025
Active Locations (33)
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1
University Hospital Mannheim
Mannheim, Baden-Wurttemberg, Germany, 68167
2
RHÖN-KLINIKUM Campus Bad Neustadt
Bad Neustadt an der Saale, Bavaria, Germany, 97616
3
Therapiezentrum Burgau
Burgau, Bavaria, Germany, 89331
4
REGIOMED Klinikum Coburg
Coburg, Bavaria, Germany, 96450