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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03040622
Recruitment Status : Active, not recruiting
First Posted : February 2, 2017
Last Update Posted : October 10, 2019
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Inova Health Care Services

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

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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

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




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 ]


Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040622


Locations
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United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
Inova Health Care Services
Boston Scientific Corporation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Inova Health Care Services
ClinicalTrials.gov Identifier: NCT03040622    
Other Study ID Numbers: 16-2583
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019

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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