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

• ClinicalTrials.gov Identifier: NCT03040622
• Recruitment Status: Active, not recruiting
• First Posted: February 2, 2017
• Last Update Posted: October 10, 2019
• Sponsor: Inova Health Care Services
• Collaborator: Boston Scientific Corporation
• Information provided by (Responsible Party): Inova Health Care Services

Study Description

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.

Condition or disease	Intervention/treatment
Left Atrial Appendage Closure; WATCHMAN Device Implantation	Device: WATCHMAN Left Atrial Appendage Closure

Study Design

• Study Type: Observational
• Estimated Enrollment: 32 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: The Evaluation of Thrombogenicity in Patients Undergoing WATCHMAN Left Atrial Appendage Closure Trial
• Actual Study Start Date: March 1, 2017
• Estimated Primary Completion Date: October 15, 2019
• Estimated Study Completion Date: December 31, 2019

Groups and Cohorts

Group/Cohort	Intervention/treatment
Watchman Left Atrial Appendage Closure	Device: WATCHMAN Left Atrial Appendage Closure; WATCHMAN Left Atrial Appendage Closure

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Frequency of high on-treatment platelet reactivity. [ Time Frame: 12 Months ]
2. Frequency of low, medium, and high risk thrombogenic phenotype within the study population. [ Time Frame: 12 Months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Subjects >18 years of age scheduled for left atrial appendage closure procedure with the WATCHMAN device.

Criteria

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.

Contacts and Locations

Locations

United States, Virginia

Inova Fairfax Hospital

Falls Church, Virginia, United States, 22042

Sponsors and Collaborators

Inova Health Care Services

Boston Scientific Corporation

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sherwood M, Bliden KP, Ilkhanoff L, Venkataraman G, Strickberger A, Yazdani S, McSwain R, Rashid H, Navarese EP, Plummer T, Batchelor W, Chaudhary R, Tantry US, Gurbel PA. Detailed thrombogenicity phenotyping and 1 year outcomes in patients undergoing WATCHMAN implantation: (TARGET-WATCHMAN) a case-control study. J Thromb Thrombolysis. 2020 Oct;50(3):484-498. doi: 10.1007/s11239-020-02205-5.

• Responsible Party: Inova Health Care Services
• ClinicalTrials.gov Identifier: NCT03040622
• Other Study ID Numbers: 16-2583
• First Posted: February 2, 2017
• Last Update Posted: October 10, 2019
• Last Verified: October 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Inova Health Care Services:

WATCHMAN; Left Atrial Appendage Closure; Thrombosis; Platelet Function