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

Inova Health Care Services1 site in 1 country35 target enrollmentMarch 1, 2017

ConditionsLeft Atrial Appendage Closure WATCHMAN Device Implantation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Left Atrial Appendage Closure
Sponsor: Inova Health Care Services
Enrollment: 35
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 1, 2017

End Date

December 31, 2019

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Inova Health Care Services

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

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.)
Number of Participants With Major Adverse Clinical Events (MACE) Post Watchman Implant(within 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(Assessed at 1 year post implant)