This study will evaluate thrombogenicity in patients undergoing left atrial appendage closure using the WATCHMAN device. Parameters of thrombosis and platelet function, as well as other bio-markers, will be measure before, during, and after WATCHMAN implantation at several follow up visits.
Study Type
OBSERVATIONAL
Enrollment
35
WATCHMAN Left Atrial Appendage Closure
Inova Fairfax Hospital
Falls Church, Virginia, United States
Comparison of Thrombin Induced Platelet-fibrin Clot Strength (TIP-FCS) Between Patients With and Without Device Related Thrombosis (DRT) Assessed at 1-year of Watchman Implant
Comparison of thrombin induced platelet-fibrin clot strength (TIP-FCS) as measured using thromboelastography (TEG-6s) between patients with and without device related thrombosis (DRT) assessed by transesophageal echocardiogram after left atrial appendage closure (LAAC) with Watchman device. TIP-FCS \>67mm has been associated with increased risk of hypercoagulability.
Time frame: Assessed at 1 year post implant.
Comparison of Fibrin Clot Strength (FCS) Between Patients With and Without Device Related Thrombosis (DRT) Assessed at 1-year After Watchman Implant
Comparison of fibrin clot strength (FCS) as measured using thromboelastography (TEG-6s) between patients with and without device related thrombosis (DRT) assessed by transesophageal echocardiogram after left atrial appendage closure (LAAC) with Watchman device. FCS \>32mm has been associated with increased risk of thrombosis.
Time frame: Assessed at 1 year post implant.
Comparison of D-dimer Levels Between Patients With and Without Device Related Thrombosis (DRT) Assessed at 1-year of Watchman Implant
Comparison of D-dimer levels as measured using ACL TOP 300 hemostasis testing system between patients with and without device related thrombosis (DRT) assessed by transesophageal echocardiogram after left atrial appendage closure (LAAC) with Watchman device. D-dimer levels \>500ng/ml are associated with thrombo-embolic diseases.
Time frame: Assessed at 1 year post implant
Number of Participants With Major Adverse Clinical Events (MACE) Post Watchman Implant
Number of participants with MACE \[all-cause death, systemic or pulmonary embolism, MI (myocardial ischemia) , TIA (transient ischemic attack) , stroke, DRT, and BARC bleeding (2,3, or 5) \] post Watchman implant..
Time frame: within 1-year post implant
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