Afib Atrial fibrillation
Conditions
Interventions
None listed
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - The subject is aged 18 years or older - The subject is accepted/scheduled for left atrial appendage closure - The subject has a CHA*DS*-VASc Score >=2 (male) or >=3 (female) - The subject or legal representative is able to understand and is willing to provide written informed consent to participate in the trial.
Exclusion criteria
Exclusion criteria: - Unable or unwilling to return for required follow-up visits and examinations - Mechanical heart valves or valvular disease requiring surgery or interventional procedure - Ongoing major bleeding or complicated or recent (50 mmHg) or regurgitation grade 3 or more - Planned CEA for significant carotid artery disease - Life expectancy of less than 1 year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study will capture the following (exploratory) primary endpoints: • Coagulation activation: TAT (thrombin-antitrombin III complex), prothrombin 1+2, and factor XIIa • Platelet reactivity as measured with multiple platelet function tests: Multiplate and Pselectin • Overall thrombus formation and clot lysis assessment using T-TAS (total thrombus formation analysis system), TEG (thromboelastography), TGT (thrombin generation test, fibrinopeptide A+B, fibrinogen, vWF (von Willebrand factor), PT, APTT • Fibrinolysis: d-dimer and plasmin inhibitor (i.e. alfa-2-antiplasmin) • CYP2C19 polymorphism: carriers of one of the loss-of-function *2 and *3 alleles will be stratified as intermediate metabolizers, patients with 2 loss-of-function alleles will be stratified as poor metabolizers Platelet function and thrombin generation testing will be performed in blood samples collected before the procedure, directly after LAAO, and after 14 days, 3 months and 6 months. The goal of the study is to evaluate platelet inhibition and thrombin generation after LAAO with regard to clinical endpoints and patient characteristics such as CYP2C19 genotype and antithrombotic regimen. Procedural characteristics such as type of device and echographic parameters will also be taken into account. | — |
Secondary
| Measure | Time frame |
|---|---|
| In addition to coagulation endpoints and CYP2C19 genotype, secondary clinically oriented endpoints during 12-month follow-up will include: • The composite of stroke (ischemic or hemorrhagic), TIA, systemic embolism and cardiovascular death. • Ischemic stroke • Disabling stroke • Separate ischemic or hemorrhagic stroke, mortality (both cardiovascular and all-cause), TIA, systemic embolism • Major bleeding event rate (according to BARC criteria), both procedural up to 7 days, as well as total • Minor bleeding event rate, both procedural up to 7 days, as well as total • Procedural efficacy of LAAO up to 30 days • Adverse events rate at 30 days, and from 30 days until end of follow up • LAA sealing efficacy according to manufacturer*s definitions at all the predefined LAA CT/TEE imaging moments • Device related thrombus event rate • Quality of life assessments at regular basis in follow up (SF-12, HADS, EQ5D5L) | — |
Countries
Netherlands
Outcome results
None listed