Comparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJena University Hospital
About this trial
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 criteria
Qualifiers
Signed written informed consent
Documented atrial fibrillation (paroxysmal, persistent, long-standing persistent or permanent)
CHA2DS2VASc-Score ≥2
Status post intracranial bleeding >6 weeks
Disqualifiers
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
Trial design
Treatments tested in this trial
- Percutaneous closure of the LAA (Watchman / Watchman FLX)
Treatment groups
530 Participants
are divided into 2 treatment groupsSponsors and collaborators
Jena University Hospital
Lead sponsor
KCRI
Collaborator
Source ClinicalTrials.gov