The Evaluation of Thrombogenicity in Patients Undergoing WATCHMAN Left Atrial Appendage Closure Trial

Study Overview
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Brief Summary
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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.

Official Title
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The Evaluation of Thrombogenicity in Patients Undergoing WATCHMAN Left Atrial Appendage Closure Trial

Conditions
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Left Atrial Appendage Closure, WATCHMAN Device Implantation

Intervention / Treatment
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* Device: WATCHMAN Left Atrial Appendage Closure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject indicated and scheduled for WATCHMAN device implantation at IHVI. Subject may be of either sex and of any race, and must be >18 years of age. Subject must be willing and able to give appropriate informed consent. The subject is able to read and has signed and dated the informed consent document including authorization permitting release of personal health information approved by the investigator's Institutional Review Board (IRB). Exclusion Criteria: - Subjects with contraindications for WATCHMAN device implantation Intracardiac thrombus is visualized by echocardiographic imaging An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present The LAA anatomy will not accommodate a device Any of the customary contraindications for other percutaneous catheterization procedures (e.g., patient size too small to accommodate TEE probe or required catheters) or conditions (e.g., active infection, bleeding disorder) are present. There are contraindications to the use of warfarin, aspirin, or clopidogrel The patient has a known hypersensitivity to any portion of the device material or the individual components such that the use of the WATCHMAN Device is contraindicated Concurrent participation in any investigational study. Subject likely to not be available to complete all protocol-required study visits or procedures, to the best of the subject's and investigator's knowledge History or evidence of any other clinically significant disorder, condition, or disease other than those outlined above that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Watchman Left Atrial Appendage Closure<br> | Device: WATCHMAN Left Atrial Appendage Closure<br>* WATCHMAN Left Atrial Appendage Closure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet Aggregation measured by Light Transmissions Aggregometry with 5 and 20 µM ADP, 2mM AA, and 4ug/ml collagen as agonists. |  | 12 Months | 
| Thrombelastography preformed to determine physical characteristics of the platelet-fibrin clot. |  | 12 Months | 
| Thrombin generation measured by thrombogram (CAT assay) to identify patients with hypo- or hypercoagulable phenotypes. |  | 12 Months | 
| Biomarker measurements to determine any that may predict thrombo-embolic events. | Biomarkers include fibrinogen, d-dimer, hsCRP, PAI, Urninary TxB2, sST2, and Galectin-3. | 12 Months | 
| Left Atrial Thrombus measured by transesophageal echocardiography (TEE). |  | 12 Months | 
| Major or clinically-relevant non-major bleeding. |  | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of high on-treatment platelet reactivity. |  | 12 Months | 
| Frequency of low, medium, and high risk thrombogenic phenotype within the study population. |  | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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WATCHMAN, Left Atrial Appendage Closure, Thrombosis, Platelet Function