Comparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding.

Launched by JENA UNIVERSITY HOSPITAL · Mar 5, 2020

Keywords

ClinConnect Summary

This clinical trial is studying two ways to help prevent strokes in patients with atrial fibrillation (AF) who have experienced an intracranial bleed (bleeding in the brain). One option is to use blood-thinning medications called anticoagulants, which help prevent clots but can also increase the risk of bleeding. The other option is a procedure that closes off a part of the heart called the left atrial appendage (LAA), which can also reduce the risk of clots. The goal of the study is to see which treatment is more effective and safe for these patients.

To participate in the trial, you need to be at least 18 years old, have a history of atrial fibrillation, and have had an intracranial bleed at least six weeks ago. You should also be able to use a device that closes off the left atrial appendage. If you meet these criteria, you may be eligible to join the study. Participants will receive either the anticoagulant therapy or the LAA closure procedure, and the study will monitor their progress over time. It's important to know that all the treatments used in the trial are already approved for use.

Gender

ALL

Eligibility 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