Clinical trial NCT03040622: The Evaluation of Thrombogenicity in Patients Undergoing WATCHMAN Left Atrial Appendage Closure Trial
Official title: The Evaluation of Thrombogenicity in Patients Undergoing WATCHMAN Left Atrial Appendage Closure Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Left Atrial Appendage Closure
WATCHMAN Device Implantation
Keywords: WATCHMAN
Left Atrial Appendage Closure
Thrombosis
Platelet Function
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2017-02-02
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects \>18 years of age scheduled for left atrial appendage closure procedure with the WATCHMAN device.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Assessed at 1 year post implant.
Secondary outcomes:
measure: Comparison of Fibrin Clot Strength (FCS) Between Patients With and Without Device Related Thrombosis (DRT) Assessed at 1-year After Watchman Implant
timeFrame: Assessed at 1 year post implant.
measure: Comparison of D-dimer Levels Between Patients With and Without Device Related Thrombosis (DRT) Assessed at 1-year of Watchman Implant
timeFrame: Assessed at 1 year post implant
measure: Number of Participants With Major Adverse Clinical Events (MACE) Post Watchman Implant
timeFrame: within 1-year post implant
Other outcomes:
Locations:
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
Study officials:
References:
citation: 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.