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

Completed

Conditions: Left Atrial Appendage Closure
WATCHMAN Device Implantation

Interventions: Device: WATCHMAN Left Atrial Appendage Closure

Registration Number: NCT03040622

Lead Sponsor: Inova Health Care Services

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 35

Inclusion Criteria

Subject indicated and scheduled for WATCHMAN device implantation at IHVI (Inova Heart and Vascular Institute)
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 (Left atrial appendage) 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 - transesophageal echocardiography 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

Ligated or oversewn left atrium
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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Watchman Left Atrial Appendage Closure	WATCHMAN Left Atrial Appendage Closure	-

Primary Outcome Measures

Name	Time	Method
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	Assessed at 1 year post 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.

Secondary Outcome Measures

Name	Time	Method
Comparison of Fibrin Clot Strength (FCS) Between Patients With and Without Device Related Thrombosis (DRT) Assessed at 1-year After Watchman Implant	Assessed at 1 year post 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.
Number of Participants With Major Adverse Clinical Events (MACE) Post Watchman Implant	within 1-year post 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..
Comparison of D-dimer Levels Between Patients With and Without Device Related Thrombosis (DRT) Assessed at 1-year of Watchman Implant	Assessed at 1 year post 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.