Left Atrial Appendage Closure, WATCHMAN Device Implantation
Conditions
Keywords
WATCHMAN, Left Atrial Appendage Closure, Thrombosis, Platelet Function
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.
Interventions
WATCHMAN Left Atrial Appendage Closure
Sponsors
Boston Scientific Corporation
Inova Health Care Services
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Assessed at 1 year post implant. | Comparison of thrombin induced platelet-fibrin clot strength (TIP-FCS) as measured using thromboelastography (TEG-6s) between patients with and without device related thrombosis (DRT) assessed by transesophageal echocardiogram after left atrial appendage closure (LAAC) with Watchman device. TIP-FCS \>67mm has been associated with increased risk of hypercoagulability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Fibrin Clot Strength (FCS) Between Patients With and Without Device Related Thrombosis (DRT) Assessed at 1-year After Watchman Implant | Assessed at 1 year post implant. | Comparison of fibrin clot strength (FCS) as measured using thromboelastography (TEG-6s) between patients with and without device related thrombosis (DRT) assessed by transesophageal echocardiogram after left atrial appendage closure (LAAC) with Watchman device. FCS \>32mm has been associated with increased risk of thrombosis. |
| Comparison of D-dimer Levels Between Patients With and Without Device Related Thrombosis (DRT) Assessed at 1-year of Watchman Implant | Assessed at 1 year post implant | Comparison of D-dimer levels as measured using ACL TOP 300 hemostasis testing system between patients with and without device related thrombosis (DRT) assessed by transesophageal echocardiogram after left atrial appendage closure (LAAC) with Watchman device. D-dimer levels \>500ng/ml are associated with thrombo-embolic diseases. |
| Number of Participants With Major Adverse Clinical Events (MACE) Post Watchman Implant | within 1-year post implant | Number of participants with MACE \[all-cause death, systemic or pulmonary embolism, MI (myocardial ischemia) , TIA (transient ischemic attack) , stroke, DRT, and BARC bleeding (2,3, or 5) \] post Watchman implant.. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Watchman Left Atrial Appendage Closure WATCHMAN Left Atrial Appendage Closure: WATCHMAN Left Atrial Appendage Closure | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | unable to implant device | 3 |
Baseline characteristics
| Characteristic | Watchman Left Atrial Appendage Closure |
|---|---|
| Age, Continuous | 76 years STANDARD_DEVIATION 8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Region of Enrollment United States | 35 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 32 |
| other Total, other adverse events | 0 / 32 |
| serious Total, serious adverse events | 17 / 32 |
Outcome results
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
Comparison of thrombin induced platelet-fibrin clot strength (TIP-FCS) as measured using thromboelastography (TEG-6s) between patients with and without device related thrombosis (DRT) assessed by transesophageal echocardiogram after left atrial appendage closure (LAAC) with Watchman device. TIP-FCS \>67mm has been associated with increased risk of hypercoagulability.
Time frame: Assessed at 1 year post implant.
Population: The total group was separated into participants with and without DRT and TIP-FCS was compared between groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| With Device Related Thrombosis | 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 mm | Standard Deviation 1.8 |
| Without Device Related Thrombosis | 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 | 62.7 mm | Standard Deviation 4.7 |
p-value: 0.06ANOVA
Secondary
Comparison of D-dimer Levels Between Patients With and Without Device Related Thrombosis (DRT) Assessed at 1-year of Watchman Implant
Comparison of D-dimer levels as measured using ACL TOP 300 hemostasis testing system between patients with and without device related thrombosis (DRT) assessed by transesophageal echocardiogram after left atrial appendage closure (LAAC) with Watchman device. D-dimer levels \>500ng/ml are associated with thrombo-embolic diseases.
Time frame: Assessed at 1 year post implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| With Device Related Thrombosis | Comparison of D-dimer Levels Between Patients With and Without Device Related Thrombosis (DRT) Assessed at 1-year of Watchman Implant | 1712 ng/ml | Standard Deviation 2330 |
| Without Device Related Thrombosis | Comparison of D-dimer Levels Between Patients With and Without Device Related Thrombosis (DRT) Assessed at 1-year of Watchman Implant | 283 ng/ml | Standard Deviation 213 |
p-value: 0.001ANOVA
Secondary
Comparison of Fibrin Clot Strength (FCS) Between Patients With and Without Device Related Thrombosis (DRT) Assessed at 1-year After Watchman Implant
Comparison of fibrin clot strength (FCS) as measured using thromboelastography (TEG-6s) between patients with and without device related thrombosis (DRT) assessed by transesophageal echocardiogram after left atrial appendage closure (LAAC) with Watchman device. FCS \>32mm has been associated with increased risk of thrombosis.
Time frame: Assessed at 1 year post implant.
Population: The total group was separated into participants with and without DRT and FCS was compared between groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| With Device Related Thrombosis | Comparison of Fibrin Clot Strength (FCS) Between Patients With and Without Device Related Thrombosis (DRT) Assessed at 1-year After Watchman Implant | 35.6 mm | Standard Deviation 6 |
| Without Device Related Thrombosis | Comparison of Fibrin Clot Strength (FCS) Between Patients With and Without Device Related Thrombosis (DRT) Assessed at 1-year After Watchman Implant | 24.4 mm | Standard Deviation 6.6 |
p-value: 0.009ANOVA
Secondary
Number of Participants With Major Adverse Clinical Events (MACE) Post Watchman Implant
Number of participants with MACE \[all-cause death, systemic or pulmonary embolism, MI (myocardial ischemia) , TIA (transient ischemic attack) , stroke, DRT, and BARC bleeding (2,3, or 5) \] post Watchman implant..
Time frame: within 1-year post implant
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| With Device Related Thrombosis | Number of Participants With Major Adverse Clinical Events (MACE) Post Watchman Implant | Device Related Thrombosis | 3 Participants |
| With Device Related Thrombosis | Number of Participants With Major Adverse Clinical Events (MACE) Post Watchman Implant | All-Cause Death | 2 Participants |
| With Device Related Thrombosis | Number of Participants With Major Adverse Clinical Events (MACE) Post Watchman Implant | TIA | 1 Participants |
| With Device Related Thrombosis | Number of Participants With Major Adverse Clinical Events (MACE) Post Watchman Implant | BARC Bleeding | 4 Participants |
| With Device Related Thrombosis | Number of Participants With Major Adverse Clinical Events (MACE) Post Watchman Implant | Pulmonary Embolism | 1 Participants |