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The purpose of this study is to confirm the safety and effectiveness of the BSJ003W in Japanese patients with non-valvular atrial fibrillation at increased risk of thromboembolism in Japanese Clinical environment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BSJ003W | Experimental | BSJ003W implant group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BSJ003W | Device | BSJ003W implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complications; One of the Following Events | All-cause death, ischemic stroke, systemic embolism, or device- or procedure- related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, arteriolar-venular fistula repair, or other major endovascular repair. | Between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later |
| Number of Participants With One of the Following Events: Stroke (All/ Ischemic/ Hemorrhagic), Systemic Embolism and Cardiovascular(CV) Death (Including Unexplained Cause) | The occurrence of composite events including stroke (all/ ischemic/ hemorrhagic), systemic embolism and cardiovascular death (including unexplained cause) till 6-month post implant | 24-month |
| The Rate of Effective Left Atrial Appendage (LAA) Closure | The effective LAA closure is defined as peri-device flow <= 5mm demonstrated by TEE. TEE measurements will be assessed by an independent Core Laboratory. | 45-day, 6-month, 12-month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Major Bleeding | Major bleeding is defined as per BARC bleeding definition type 3 or 5. Type 3 Type 3a: Overt bleeding plus hemoglobin drop of 3 to 5 g/dL* (provided hemoglobin drop is related to bleed), Any transfusion with overt bleeding Type 3b: Overt bleeding plus hemoglobin drop 5 g/dL* (provided hemoglobin drop is related to bleed) Cardiac tamponade, Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid), Bleeding requiring intravenous vasoactive agents Type 3c: Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal), Subcategories confirmed by autopsy or imaging or lumbar puncture Intraocular bleed compromising vision Type 5: fatal bleeding Type 5a: Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious Type 5b: Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success Rate | Technical Success defined as successful delivery and release of BSJ003W into the LAA including successful recapture and retrieval if necessary. | Implant Day |
| Warfarin Discontinuation Rate |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kazutaka Aonuma | Tsukuba University Hospital | Principal Investigator |
| Shigeru Saito | Shonankamakura General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kokura Memorial Hospital | Kitakyushu | Fukuoka | 802-8255 | Japan | ||
| University of Tsukuba Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32595176 | Derived | Aonuma K, Yamasaki H, Nakamura M, Matsumoto T, Takayama M, Ando K, Hirao K, Goya M, Morino Y, Hayashida K, Kusano K, Gomi Y, Main ML, Uchida T, Saito S. Efficacy and Safety of Left Atrial Appendage Closure With WATCHMAN in Japanese Nonvalvular Atrial Fibrillation Patients - Final 2-Year Follow-up Outcome Data From the SALUTE Trial. Circ J. 2020 Jul 22;84(8):1237-1243. doi: 10.1253/circj.CJ-20-0196. Epub 2020 Jun 26. |
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The confidentiality of records/data obtained in the trial will remain anonymous for analysis and publication.
The information and data, obtained from the trial is used without personal identification
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| ID | Title | Description |
|---|---|---|
| FG000 | Implant (ITT) | BSJ003W implant group (ITT) : 42 subjects |
| FG001 | Roll-in | 12 Roll-in subjects |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Implant (ITT) | Implant (ITT) group: 42 subjects |
| BG001 | Roll-in | Roll-in group: 12 subjects |
| 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 | Number of Participants With Complications; One of the Following Events | All-cause death, ischemic stroke, systemic embolism, or device- or procedure- related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, arteriolar-venular fistula repair, or other major endovascular repair. | Posted | Count of Participants | Participants | Between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later |
|
2 years
Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.
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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 | Implant (ITT) | Implant (ITT) group: 42 subjects | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea - Heart Failure | Respiratory, thoracic and mediastinal disorders | Internal difinitions | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Head, Eyes, Ears, Nose, Throat (Heent) | General disorders | Internal difinitions | Systematic Assessment | This AE term includes some symptoms or events reported by the site; ITT (19) includes Common cold (4), Pharyngitis (2), Vertigo (2), Root fracture (2). Roll-in (11) includes Common cold (6). The remaining AEs were reported in one event each. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yutaka Gomi | Boston Scientific Japan | +81.3.6853.7500 | Yutaka.Gomi@bsci.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 24, 2016 | Jun 4, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 10, 2017 | Dec 18, 2018 | SAP_001.pdf |
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| 24-month |
| Number of Participants With Clinically Overt Non-fatal Bleeding | Clinically overt non-fatal bleeding is defined as per BARC bleeding definition type 2. Type 2: any overt, actionable sign of hemorrhage (eg, more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for type 3, 4, or 5 but does meet at least one of the following criteria: (1) requiring nonsurgical, medical intervention by a healthcare professional, (2) leading to hospitalization or increased level of care, or (3) prompting evaluation | 24-month |
| Number of Participants With Ischemic Stroke or Systemic Embolism | The occurrence of ischemic stroke or systemic embolism (excluding 7 days after implanting or day after hospital discharge whichever is the later) | 24-month |
Warfarin discontinuation rate per protocol. If the TEE shows adequate seal of the LAA with a jet around the device <= 5mm, warfarin therapy should be discontinued.
Some patients restarted warfarin therapy due to the reasons other than the status of LAA closure.
| 45-day, 6-month, 12-month |
| Tsukuba |
| Ibaraki |
| 305-8576 |
| Japan |
| Iwate Medical University Hospital | Morioka | Iwate | 020-8505 | Japan |
| Shonan Kamakura General Hospital | Kamakura | Kanagawa | 247-8533 | Japan |
| Sendai Kousei Hospital | Sendai | Miyagi | 980-0873 | Japan |
| National Cerebral and Cardiovascular Center | Suita | Osaka | 565-8565 | Japan |
| Tokyo Medical and Dental University Medical Hospital | Bunkyo-ku | Tokyo | 113-8519 | Japan |
| Sakakibara Heart Institute | Fuchū | Tokyo | 183-0003 | Japan |
| Toho University Ohashi Medical Center | Meguro-ku | Tokyo | 153-8515 | Japan |
| Keio University Hospital | Shinjuku-ku | Tokyo | 160-8582 | Japan |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| CHA2DS2-VASc score | CHA2DS2-VASc score is recommended to assess stroke risk. CHA2DS2-VASc score is calculated by the summed of the following factors; C:1: Congestive Heart Failure/ LV dysfunction, H:1: Hypertension, A:2: Age >75, D:1: Diabetes, S:2: Stroke/ TIA, V:1: Vascular disease, A:1: Age 65-74, Sc:1: Female. Total Score range: 0-9. Higher score indicates the higher stroke risk. | Mean | Standard Deviation | units on a scale |
|
| Atrial Fibrillation pattern | Count of Participants | Participants |
|
| HAS-BLED score | HAS-BLED score is a Bleeding risk scores to quantify hemorrhage risk. HAS-BLED score is calculated by the summed of the following factors; H: Hypertension, A: Abnormal renal function, Abnormal liver function, S: Stroke, B: Bleeding, L: Labile INRs, E: Elderly > 65 years, D: Drugs (NSAIDs) or Alcohol. Total Score Range: 0-9. Higher score indicates higher bleeding risk. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Participants With One of the Following Events: Stroke (All/ Ischemic/ Hemorrhagic), Systemic Embolism and Cardiovascular(CV) Death (Including Unexplained Cause) | The occurrence of composite events including stroke (all/ ischemic/ hemorrhagic), systemic embolism and cardiovascular death (including unexplained cause) till 6-month post implant | Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort. | Posted | Count of Participants | Participants | 24-month |
|
|
|
| Primary | The Rate of Effective Left Atrial Appendage (LAA) Closure | The effective LAA closure is defined as peri-device flow <= 5mm demonstrated by TEE. TEE measurements will be assessed by an independent Core Laboratory. | Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort. One subject in Roll-in cohort at 6-month was not able to assessed by the Core laboratory due to the quality of the images | Posted | Count of Participants | Participants | 45-day, 6-month, 12-month |
|
|
|
| Secondary | Number of Participants With Major Bleeding | Major bleeding is defined as per BARC bleeding definition type 3 or 5. Type 3 Type 3a: Overt bleeding plus hemoglobin drop of 3 to 5 g/dL* (provided hemoglobin drop is related to bleed), Any transfusion with overt bleeding Type 3b: Overt bleeding plus hemoglobin drop 5 g/dL* (provided hemoglobin drop is related to bleed) Cardiac tamponade, Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid), Bleeding requiring intravenous vasoactive agents Type 3c: Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal), Subcategories confirmed by autopsy or imaging or lumbar puncture Intraocular bleed compromising vision Type 5: fatal bleeding Type 5a: Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious Type 5b: Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation | Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort. | Posted | Count of Participants | Participants | 24-month |
|
|
|
| Secondary | Number of Participants With Clinically Overt Non-fatal Bleeding | Clinically overt non-fatal bleeding is defined as per BARC bleeding definition type 2. Type 2: any overt, actionable sign of hemorrhage (eg, more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for type 3, 4, or 5 but does meet at least one of the following criteria: (1) requiring nonsurgical, medical intervention by a healthcare professional, (2) leading to hospitalization or increased level of care, or (3) prompting evaluation | Posted | Count of Participants | Participants | 24-month |
|
|
|
| Secondary | Number of Participants With Ischemic Stroke or Systemic Embolism | The occurrence of ischemic stroke or systemic embolism (excluding 7 days after implanting or day after hospital discharge whichever is the later) | Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort. | Posted | Count of Participants | Participants | 24-month |
|
|
|
| Other Pre-specified | Technical Success Rate | Technical Success defined as successful delivery and release of BSJ003W into the LAA including successful recapture and retrieval if necessary. | Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort. | Posted | Count of Participants | Participants | Implant Day |
|
|
|
| Other Pre-specified | Warfarin Discontinuation Rate | Warfarin discontinuation rate per protocol. If the TEE shows adequate seal of the LAA with a jet around the device <= 5mm, warfarin therapy should be discontinued. Some patients restarted warfarin therapy due to the reasons other than the status of LAA closure. | Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort. | Posted | Count of Participants | Participants | 45-day, 6-month, 12-month |
|
|
|
| 42 |
| 13 |
| 42 |
| 31 |
| 42 |
| EG001 | Roll-in | Roll-in cohort: 12 subjects | 1 | 12 | 6 | 12 | 11 | 12 |
| Renal | Renal and urinary disorders | Internal difinitions | Systematic Assessment |
|
| Device Thrombus Atrial Facing - Post Procedure | Blood and lymphatic system disorders | Internal difinitions | Systematic Assessment |
|
| Endocrine | Endocrine disorders | Internal difinitions | Systematic Assessment |
|
| Major Bleed Requiring Transfusion | Blood and lymphatic system disorders | Internal difinitions | Systematic Assessment |
|
| Stroke (Ischemic) | Nervous system disorders | Internal difinitions | Systematic Assessment |
|
| Gastrointestinal Bleeding | Gastrointestinal disorders | Internal difinitions | Systematic Assessment |
|
| Pericarditis - Unrelated (Non Study) Procedure Or Device | Cardiac disorders | Internal difinitions | Systematic Assessment |
|
| Sinus Bradycardia | Cardiac disorders | Internal difinitions | Systematic Assessment |
|
| Coronary Artery Disease | Cardiac disorders | Internal difinitions | Systematic Assessment |
|
| Multiple Heart Failure Symptoms | Cardiac disorders | Internal difinitions | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Internal difinitions | Systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | Internal difinitions | Systematic Assessment |
|
| Chest Pain - Other | Cardiac disorders | Internal difinitions | Systematic Assessment |
|
| Cranial Bleed - Without Stroke | Nervous system disorders | Internal difinitions | Systematic Assessment |
|
| Dizziness | General disorders | Internal difinitions | Systematic Assessment |
|
| Head, Eyes, Ears, Norse, Throat (HEENT) | General disorders | Internal difinitions | Systematic Assessment | The AE name reported by the site was "Chronic otitis media aggravated". |
|
| Heart Failure Symptoms - Unspecified | Cardiac disorders | Internal difinitions | Systematic Assessment |
|
| Hematoma | Vascular disorders | Internal difinitions | Systematic Assessment |
|
| Led to Death | General disorders | Internal difinitions | Systematic Assessment |
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| Sinus Bradycardia | Cardiac disorders | Internal difinitions | Systematic Assessment |
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| Systemic Infection | Infections and infestations | Internal difinitions | Systematic Assessment |
|
| Torsades Des Pointes | Cardiac disorders | Internal difinitions | Systematic Assessment |
|
| Transient Ischemic Attack (TIA) | Nervous system disorders | Internal difinitions | Systematic Assessment |
|
| Vetricular Tachycardia (VT) / Monomorphic VT | Cardiac disorders | Internal difinitions | Systematic Assessment |
|
| Chest Pain - Heart Failure | Cardiac disorders | Internal difinitions | Systematic Assessment |
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| Death | General disorders | Internal difinitions | Systematic Assessment |
|
| Gastrointestinal | Gastrointestinal disorders | Internal difinitions | Systematic Assessment |
|
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| Gastrointestinal | Gastrointestinal disorders | Internal difinitions | Systematic Assessment |
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| Integumentary | Skin and subcutaneous tissue disorders | Internal difinitions | Systematic Assessment |
|
| Pulmonary | Respiratory, thoracic and mediastinal disorders | Internal difinitions | Systematic Assessment |
|
| Neurological | Nervous system disorders | Internal difinitions | Systematic Assessment |
|
| Abnormal Laboratory Values | Investigations | Internal difinitions | Systematic Assessment |
|
| Endocrine | Endocrine disorders | Internal difinitions | Systematic Assessment |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Internal difinitions | Systematic Assessment |
|
| Fever and/or Virus | Infections and infestations | Internal difinitions | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results.
| Systemic embolism |
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| Cardiovascular death |
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| At 6-month |
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| At 12-month |
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| At 6-month |
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| At 12-month |
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