The POPULAR-LAAO registry is an open-label observational prospective registry to investigate hemostatic processes following left atrial appendage occlusion.
This is an open-label observational prospective registry. The aim is to develop a better understanding of coagulation, platelet reactivity and prothrombotic factors in the first months after left atrial appendage occlusion, as occurrence of device-related thrombus and optimal postprocedural management remain a challenge after LAAO. The study population will consist of patients with non-valvular atrial fibrillation (AF) at risk for cardio-embolic stroke scheduled for left atrial appendage occlusion. In these patients, blood samples for coagulation and platelet reactivity testing will be taken, which will be gathered prior to the procedure and 1 day, 14 days, 3 months and 6 months after the procedure. Data will be analyzed longitudinally and between groups based on patient characteristics.
Study Type
OBSERVATIONAL
Enrollment
120
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, Netherlands
RECRUITINGChange in coagulation activation
Influence of LAAO on coagulation activation over time
Time frame: Pre-LAAO and post-LAAO (1 day, 2 weeks, 3 months, 6 months)
Change in platelet reactivity
Influence of LAAO on platelet reactivity over time
Time frame: Pre-LAAO and post-LAAO (1 day, 2 weeks, 3 months, 6 months)
CYP2C19 genotype
Rate of clopidogrel non-responders among LAAO patients will be assessed by determining CYP2C19 genotype
Time frame: Pre-LAAO
Separate and composite event rates of stroke (ischemic or hemorrhagic), transient ischemic attack (TIA), systemic embolism and cardiovascular death.
Time frame: Post-LAAO (3 months, 6 months, 12 months)
Major and minor bleeding event rate (according to Bleeding Academic Research Consortium criteria)
Time frame: Post-LAAO (3 months, 6 months, 12 months)
Device related thrombus event rate
Time frame: Post-LAAO (3 months, 12 months)
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