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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Watchman Left Atrial Appendage Closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WATCHMAN Left Atrial Appendage Closure | Device | WATCHMAN Left Atrial Appendage Closure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed at 1 year post implant. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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
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Subjects >18 years of age scheduled for left atrial appendage closure procedure with the WATCHMAN device.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38480590 | Derived | Gurbel PA, Bliden K, Sherwood M, Taheri H, Tehrani B, Akbari M, Yazdani S, Asgar JA, Chaudhary R, Tantry US. Development of a routine bedside CYP2C19 genotype assessment program for antiplatelet therapy guidance in a community hospital catheterization laboratory. J Thromb Thrombolysis. 2024 Apr;57(4):566-575. doi: 10.1007/s11239-024-02953-8. Epub 2024 Mar 13. | |
| 32601850 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Watchman Left Atrial Appendage Closure | Patients implanted with WATCHMAN left atrial appendage closure device in a hospital setting |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Watchman Left Atrial Appendage Closure | WATCHMAN Left Atrial Appendage Closure: WATCHMAN Left Atrial Appendage Closure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The total group was separated into participants with and without DRT and TIP-FCS was compared between groups. | Posted | Mean | Standard Deviation | mm | Assessed at 1 year post implant. |
|
1 year
Major adverse clinical outcomes monitored include: all-cause death, embolism (systemic or pulmonary), myocardial infarction, TIA, ischemic or hemorrhagic stroke, device related thrombosis, and major bleeding using the Academic Research Consortium (BARC) definition including BARC type 2, 3 or 5. DRT was defined as the presence of a persistent echogenic mobile mass attached to the WATCHMAN device confirmed by transesophageal echocardiography.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Watchman Left Atrial Appendage Closure | WATCHMAN Left Atrial Appendage Closure: WATCHMAN Left Atrial Appendage Closure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device Related Thrombosis | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Bliden | Inova Heart and Vascular Institute | 443-244-1497 | kevin.bliden@inova.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 5, 2018 | Dec 6, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 9, 2018 | Nov 18, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Assessed at 1 year post implant. |
| 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. | Assessed at 1 year post implant |
| 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.. | within 1-year post implant |
| 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Without Device Related Thrombosis | Patients without device related thrombosis within 1-year of implant |
|
|
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| 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. | The total group was separated into participants with and without DRT and FCS was compared between groups. | Posted | Mean | Standard Deviation | mm | Assessed at 1 year post implant. |
|
|
|
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| 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. | Posted | Mean | Standard Deviation | ng/ml | Assessed at 1 year post implant |
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|
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| 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.. | Posted | Count of Participants | Participants | within 1-year post implant |
|
|
|
| 2 |
| 32 |
| 17 |
| 32 |
| 0 |
| 32 |
| Major Bleeding | Vascular disorders | Non-systematic Assessment | BARC Bleeding (Type 3A) |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| TIA | Nervous system disorders | Non-systematic Assessment |
|
| Rehospitalization for atrial fibrillation with rapid ventricular rhythm | Cardiac disorders | Non-systematic Assessment |
|
| Rehospitalization for pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Rehospitalization-injury from a fall | General disorders | Non-systematic Assessment |
|
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| Measurements |
|---|
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| Pulmonary Embolism |
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| TIA |
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