The Evaluation of Thrombogenicity in Patients Undergoing WATCHMAN Left Atrial Appendage Closure Trial
Left Atrial Appendage Closure · WATCHMAN Device Implantation
Bottom Line
View on ClinicalTrials.gov: NCT03040622 ↗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
| Outcome | Result | p-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
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.
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.