Status:
RECRUITING
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Ischemic Stroke
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Atrial fibrillation (AF) is one of the most common cardiac arrhythmias and cardioembolic stroke due to AF is its major complication. Direct oral anticoagulants (DOAC) reduce the risk of cardioembolism...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Written informed consent
- Permanent, persistent, or paroxysmal spontaneous AF previously known or diagnosed during the index hospitalization.
- Recent (≤3 months) symptomatic ischemic stroke.
- Active and ongoing anticoagulation therapy at stroke onset assessed based on medical history (i.e. any therapeutic oral anticoagulation therapy \[Vitamin K antagonist/DOAC according to prescription recommendations for AF; inadequate low-dose DOAC therapy allowed for inclusion\] not stopped/paused for \>48 hours due to any reason, i.e. medical intervention or non-adherence).
- Active or planned long-term therapy with DOAC
Exclusion
- Contraindications to DOAC therapy
- Life expectancy \<1 year according to the opinion of the investigator
- Stroke due to: Ipsilateral intra/extracranial high-grade stenosis, Isolated lacunar stroke, Other well-defined stroke aetiologies (i.e., endocarditis, vasculitis, Reversible Cerebral Vasoconstriction Syndrome \[RCVS\], Posterior Reversible Encephalopathy Syndrome \[PRES\], cerebral sinus venous thrombosis)
- Previous persistent foramen ovale or atrial septum defect closure.
- Rheumatic heart disease
- Severe heart valve disease that requires treatment (severe aortic stenosis or regurgitation, severe mitral stenosis or regurgitation).
- Contraindications for TEE (relevant esophageal varices, esophageal stricture, history of esophageal cancer).
- Cardiac or non-cardiac surgical procedure within 30 days of randomization
- Enrolled in another investigation of a cardiovascular device or investigating secondary prevention therapy.
- Severely reduced Left Ventricular Ejection Fraction (LVEF) \<30%.
- Severe renal impairment as described in the summary of medicinal product characteristics for the chosen DOAC (e.g. rivaroxaban, apixaban and edoxaban creatinine clearance \<15 ml/min; dabigatran creatinine clearance \<30 ml/min).
- Hypertrophic cardiomyopathy
- Intracardiac tumor
- Ventricular thrombus
- Acute cardiac decompensation
- LAA is obliterated or surgically ligated
- Persistent proximal LAA thrombus despite 4 weeks of anticoagulation (if a proximal thrombus in the LAA is found, anticoagulation with vitamin K antagonist (INR 2.5-3.5) may be started, and if the thrombus disappears, the patient may be eligible for LAAO)
- Pregnancy or breastfeeding (pregnancy test in urine or blood to be performed at screening for women of childbearing potential)
Key Trial Info
Start Date :
May 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
482 Patients enrolled
Trial Details
Trial ID
NCT05976685
Start Date
May 1 2024
End Date
June 1 2028
Last Update
January 8 2026
Active Locations (21)
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1
AZ Sint Jan Brugge
Bruges, Belgium, 8000
2
Brussels University Hospital
Brussels, Belgium, 1090
3
UCLouvain - Cliniques universitaires Saint-Luc
Brussels, Belgium, 1200
4
HUmani CHU Charleroi-Chimay
Charleroi, Belgium, 6000