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

NCT03040622 | Completed Results FDA Device

• 1 other identifier: 16-2583
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Left Atrial Appendage Closure; WATCHMAN Device Implantation

Keywords

WATCHMAN; Left Atrial Appendage Closure; Thrombosis; Platelet Function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 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

• Number of Participants With Major Adverse Clinical Events (MACE) Post Watchman Implant

  within 1-year post implant

Study Arms (1)

Watchman Left Atrial Appendage Closure

Device: WATCHMAN Left Atrial Appendage Closure

Interventions

WATCHMAN Left Atrial Appendage Closure DEVICE

WATCHMAN Left Atrial Appendage Closure

Watchman Left Atrial Appendage Closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inova Health Care Services: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Related Publications (2)

• Gurbel PA, Bliden K, Sherwood M, Taheri H, Tehrani B, Akbari M, Yazdani S, Asgar JA, Chaudhary R, Tantry US. Development of a routine bedside CYP2C19 genotype assessment program for antiplatelet therapy guidance in a community hospital catheterization laboratory. J Thromb Thrombolysis. 2024 Apr;57(4):566-575. doi: 10.1007/s11239-024-02953-8. Epub 2024 Mar 13.

  PMID: 38480590 DERIVED

• 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.

  PMID: 32601850 DERIVED

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Kevin Bliden
• Organization: Inova Heart and Vascular Institute

kevin.bliden@inova.org

443-244-1497

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: February 2, 2017
• Study Start: March 1, 2017
• Primary Completion: October 15, 2019
• Study Completion: December 31, 2019
• Last Updated: March 29, 2024
• Results First Posted: March 29, 2024

Record last verified: 2023-10

Locations

US (1)