Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Jul 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a potential new treatment for patients with atrial fibrillation (AF) who have experienced a stroke despite taking blood-thinning medications called anticoagulants. The researchers want to find out if adding a procedure to close a part of the heart called the left atrial appendage (LAA) can help reduce the risk of future strokes compared to just continuing with anticoagulant therapy alone. Patients eligible for this trial are adults aged 18 and older who have had a recent ischemic stroke (a type of stroke caused by a blockage in blood flow) while on anticoagulant treatment and have been diagnosed with AF.

Participants in the trial will be randomly assigned to receive either the LAA closure procedure along with their anticoagulant medication or to continue with anticoagulant therapy alone. The main goal is to see if the combination therapy can lower the chances of having another stroke or serious cardiovascular event. Patients will be monitored for at least six months and up to four years to track their health outcomes. It's important to note that there are specific criteria for joining the trial, including not having certain heart conditions or other medical issues that could interfere with the study. This trial aims to provide valuable insights into the best treatment options for patients who suffer strokes despite being on blood thinners.

Gender

ALL

Eligibility criteria

• 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)