Closing the left atrial appendage for patients with atrial fibrillation and stroke despite blood thinners

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of closing the left atrial appendage in patients with atrial fibrillation who have experienced an ischemic stroke despite being on anticoagulation therapy. The study aims to address the residual stroke risk that remains even with direct oral anticoagulants. By focusing on patients who have had a recent stroke, the trial seeks to determine if this intervention can reduce the likelihood of subsequent strokes. The approach combines observational data and interventional techniques to assess outcomes in a targeted patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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)

Where it's running

• AZ Sint Jan Brugge
  Bruges, Belgium Recruiting
• Brussels University Hospital
  Brussels, Belgium Recruiting
• UCLouvain - Cliniques universitaires Saint-Luc
  Brussels, Belgium Recruiting
• HUmani CHU Charleroi-Chimay
  Charleroi, Belgium Recruiting
• Universitair Ziekenhuis (UZ) Leuven
  Leuven, Belgium Recruiting
• CHU Liège Sart-Tilman
  Liège, Belgium Recruiting

Study contacts

• Principal investigator: Lorenz Räber, Prof., MD — Cardiovascular Center, Inselspital Bern
• Study coordinator: Lorenz Räber, Prof., MD, PhD
• Email: Lorenz.Raeber@insel.ch
• Phone: +41316320929

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.