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Completed

NCT Number: NCT03040622

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

WATCHMAN Left Atrial Appendage Closure

Device

WATCHMAN Left Atrial Appendage Closure

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

    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

  1. Comparison of Fibrin Clot Strength (FCS) Between Patients With and Without Device Related Thrombosis (DRT) Assessed at 1-year After Watchman Implant

    Time frame: 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.

  2. Comparison of D-dimer Levels 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 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.

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

    Time frame: 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..

Sponsors and collaborators

Lead sponsor

Inova Health Care Services

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 2, 2017
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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