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N/A N=35

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

Left Atrial Appendage Closure · WATCHMAN Device Implantation

Enrolled (actual)
35
Serious AEs
53.1%
Results posted
Mar 2024
Primary outcome: Primary: 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 — 68.0; 62.7 mm — p=0.06

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
WATCHMAN Left Atrial Appendage Closure (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Inova Health Care Services
Primary completion
Oct 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
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
68.0; 62.7 0.06
SECONDARY
Comparison of Fibrin Clot Strength (FCS) Between Patients With and Without Device Related Thrombosis (DRT) Assessed at 1-year After Watchman Implant
35.6; 24.4 0.009 sig
SECONDARY
Comparison of D-dimer Levels Between Patients With and Without Device Related Thrombosis (DRT) Assessed at 1-year of Watchman Implant
1712; 283 0.001 sig
SECONDARY
Number of Participants With Major Adverse Clinical Events (MACE) Post Watchman Implant
3; 2; 4; 1; 1

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03040622). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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