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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:8/24/2018
Start Date:March 1, 2017
End Date:September 2019
Contact:Kevin Bliden, BS, MBA
Email:kevin.bliden@inova.org
Phone:703-776-7702

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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.


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.
We found this trial at
1
site
3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Phone: 703-776-7702
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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mi
from
Falls Church, VA
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