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

Left Atrial Appendage Closure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03040622
• Other study ID #: 16-2583
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2023
• Source: Inova Health Care Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 31, 2019
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Left Atrial Appendage Closure
• WATCHMAN Device Implantation

Intervention

Device:
• WATCHMAN Left Atrial Appendage Closure
WATCHMAN Left Atrial Appendage Closure

Locations

Country	Name	City	State
United States	Inova Fairfax Hospital	Falls Church	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Inova Health Care Services	Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Assessed at 1 year post implant.
Secondary	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.	Assessed at 1 year post implant.
Secondary	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.	Assessed at 1 year post implant
Secondary	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..	within 1-year post implant