Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-01-08 @ 8:33 AM
Study NCT ID:
NCT03033134
Status:
COMPLETED
Last Update Posted:
2020-07-14
First Post:
2017-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Safety and Effectiveness of the Left Atrial Appendage Closure Therapy Using BSJ003W
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Yutaka.Gomi@bsci.com', 'phone': '+81.3.6853.7500', 'title': 'Yutaka Gomi', 'organization': 'Boston Scientific Japan'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '2 years', 'description': 'Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Implant (ITT)', 'description': 'Implant (ITT) group: 42 subjects', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 31, 'seriousNumAtRisk': 42, 'deathsNumAffected': 1, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Roll-in', 'description': 'Roll-in cohort: 12 subjects', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 11, 'seriousNumAtRisk': 12, 'deathsNumAffected': 1, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Head, Eyes, Ears, Nose, Throat (Heent)', 'notes': '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).\n\nRoll-in (11) includes Common cold (6). The remaining AEs were reported in one event each.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 19, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 11, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Integumentary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Neurological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Abnormal Laboratory Values', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Endocrine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Fever and/or Virus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}], 'seriousEvents': [{'term': 'Dyspnea - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Renal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Device Thrombus Atrial Facing - Post Procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Endocrine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Major Bleed Requiring Transfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Stroke (Ischemic)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Gastrointestinal Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Pericarditis - Unrelated (Non Study) Procedure Or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Sinus Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Multiple Heart Failure Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Chest Pain - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Cranial Bleed - Without Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Head, Eyes, Ears, Norse, Throat (HEENT)', 'notes': 'The AE name reported by the site was "Chronic otitis media aggravated".', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Heart Failure Symptoms - Unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Led to Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Sinus Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Systemic Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Torsades Des Pointes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Transient Ischemic Attack (TIA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Vetricular Tachycardia (VT) / Monomorphic VT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Chest Pain - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal difinitions'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Complications; One of the Following Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Implant (ITT)', 'description': 'Implant (ITT) group: 42 subjects'}, {'id': 'OG001', 'title': 'Roll-in', 'description': 'Roll-in cohort'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With One of the Following Events: Stroke (All/ Ischemic/ Hemorrhagic), Systemic Embolism and Cardiovascular(CV) Death (Including Unexplained Cause)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Implant (ITT)', 'description': 'Implant (ITT) group: 42 subjects'}, {'id': 'OG001', 'title': 'Roll-in', 'description': 'Roll-in cohort: 12 subjects'}], 'classes': [{'title': 'Ischemic stroke', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hemorrhagic stroke', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Systemic embolism', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cardiovascular death', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24-month', 'description': 'The occurrence of composite events including stroke (all/ ischemic/ hemorrhagic), systemic embolism and cardiovascular death (including unexplained cause) till 6-month post implant', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.'}, {'type': 'PRIMARY', 'title': 'The Rate of Effective Left Atrial Appendage (LAA) Closure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Implant (ITT)', 'description': 'Implant (ITT) group: 42 subjects'}, {'id': 'OG001', 'title': 'Roll-in', 'description': 'Roll-in cohort: 12 subjects'}], 'classes': [{'title': 'At 45-day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'At 6-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'At 12-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '45-day, 6-month, 12-month', 'description': 'The effective LAA closure is defined as peri-device flow \\<= 5mm demonstrated by TEE.\n\nTEE measurements will be assessed by an independent Core Laboratory.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.\n\nOne subject in Roll-in cohort at 6-month was not able to assessed by the Core laboratory due to the quality of the images'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Major Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Implant (ITT)', 'description': 'Implant (ITT) group: 42 subjects'}, {'id': 'OG001', 'title': 'Roll-in', 'description': 'Roll-in cohort: 12 subjects'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24-month', 'description': 'Major bleeding is defined as per BARC bleeding definition type 3 or 5.\n\nType 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\n\nType 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\n\nType 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\n\nType 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', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Overt Non-fatal Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Implant (ITT)', 'description': 'Implant (ITT) group: 42 subjects'}, {'id': 'OG001', 'title': 'Roll-in', 'description': 'Roll-in cohort: 12 subjects'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24-month', 'description': 'Clinically overt non-fatal bleeding is defined as per BARC bleeding definition type 2.\n\nType 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', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Ischemic Stroke or Systemic Embolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Implant (ITT)', 'description': 'Implant (ITT): 42 subjects'}, {'id': 'OG001', 'title': 'Roll-in', 'description': 'Roll-in cohort: 12 subjects'}], 'classes': [{'title': 'Ischemic stroke', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Systemic embolism', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24-month', 'description': 'The occurrence of ischemic stroke or systemic embolism (excluding 7 days after implanting or day after hospital discharge whichever is the later)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Technical Success Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Implant (ITT)', 'description': 'Implant (ITT) group: 42 subjects'}, {'id': 'OG001', 'title': 'Roll-in', 'description': 'Roll-in cohort: 12 subjects'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Implant Day', 'description': 'Technical Success defined as successful delivery and release of BSJ003W into the LAA including successful recapture and retrieval if necessary.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Warfarin Discontinuation Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Implant (ITT)', 'description': 'Implant (ITT) group: 42 subjects'}, {'id': 'OG001', 'title': 'Roll-in', 'description': 'Roll-in cohort: 12 subjects'}], 'classes': [{'title': 'At 45-day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'At 6-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'At 12-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '45-day, 6-month, 12-month', 'description': '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.\n\nSome patients restarted warfarin therapy due to the reasons other than the status of LAA closure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Implant (ITT)', 'description': 'BSJ003W implant group (ITT) : 42 subjects'}, {'id': 'FG001', 'title': 'Roll-in', 'description': '12 Roll-in subjects'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': '6-month Primary Endpoints', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Implant (ITT)', 'description': 'Implant (ITT) group: 42 subjects'}, {'id': 'BG001', 'title': 'Roll-in', 'description': 'Roll-in group: 12 subjects'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.5', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '70.6', 'spread': '7.4', 'groupId': 'BG001'}, {'value': '72.1', 'spread': '8.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'CHA2DS2-VASc score', 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '3.5', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '3.6', 'spread': '1.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '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.\n\nTotal Score range: 0-9. Higher score indicates the higher stroke risk.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Atrial Fibrillation pattern', 'classes': [{'categories': [{'title': 'Documented Paroxysmal', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Documented Persistent', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Documented Permanent', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HAS-BLED score', 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '3.1', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '3.0', 'spread': '1.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '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.\n\nTotal Score Range: 0-9. Higher score indicates higher bleeding risk.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-11-24', 'size': 1783426, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-06-04T22:43', 'hasProtocol': True}, {'date': '2017-11-10', 'size': 215992, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-12-18T02:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-09-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-29', 'studyFirstSubmitDate': '2017-01-16', 'resultsFirstSubmitDate': '2018-10-15', 'studyFirstSubmitQcDate': '2017-01-24', 'lastUpdatePostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-18', 'studyFirstPostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Technical Success Rate', 'timeFrame': 'Implant Day', 'description': 'Technical Success defined as successful delivery and release of BSJ003W into the LAA including successful recapture and retrieval if necessary.'}, {'measure': 'Warfarin Discontinuation Rate', 'timeFrame': '45-day, 6-month, 12-month', 'description': '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.\n\nSome patients restarted warfarin therapy due to the reasons other than the status of LAA closure.'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Complications; One of the Following Events', 'timeFrame': 'Between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later', 'description': '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.'}, {'measure': 'Number of Participants With One of the Following Events: Stroke (All/ Ischemic/ Hemorrhagic), Systemic Embolism and Cardiovascular(CV) Death (Including Unexplained Cause)', 'timeFrame': '24-month', 'description': 'The occurrence of composite events including stroke (all/ ischemic/ hemorrhagic), systemic embolism and cardiovascular death (including unexplained cause) till 6-month post implant'}, {'measure': 'The Rate of Effective Left Atrial Appendage (LAA) Closure', 'timeFrame': '45-day, 6-month, 12-month', 'description': 'The effective LAA closure is defined as peri-device flow \\<= 5mm demonstrated by TEE.\n\nTEE measurements will be assessed by an independent Core Laboratory.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Major Bleeding', 'timeFrame': '24-month', 'description': 'Major bleeding is defined as per BARC bleeding definition type 3 or 5.\n\nType 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\n\nType 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\n\nType 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\n\nType 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': 'Number of Participants With Clinically Overt Non-fatal Bleeding', 'timeFrame': '24-month', 'description': 'Clinically overt non-fatal bleeding is defined as per BARC bleeding definition type 2.\n\nType 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'}, {'measure': 'Number of Participants With Ischemic Stroke or Systemic Embolism', 'timeFrame': '24-month', 'description': 'The occurrence of ischemic stroke or systemic embolism (excluding 7 days after implanting or day after hospital discharge whichever is the later)'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Atrial Fibrillation Non-Rheumatic']}, 'referencesModule': {'references': [{'pmid': '32595176', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The subject is Japanese, over 20 years old and provides written informed consent to participate in the trial\n2. The subject has documented paroxysmal, persistent or permanent non-valvular atrial fibrillation\n3. The subject has a calculated CHA2DS2-VASc score of 2 or greater and is recommended for long-term oral anti-coagulation therapy\n4. The subject is deemed by their physicians to be suitable for anticoagulant therapy and have an appropriate rationale to seek a non-pharmacologic alternative to warfarin\n5. The subject is eligible to come off warfarin therapy if the LAA (left atrial appendage) is sealed (i.e. the subject has no other conditions that would require warfarin therapy).\n\nExclusion Criteria:\n\n1. The subject has a prior stroke (ischemic or hemorrhagic) or transient ischemic attack within the 90 days prior to consent\n2. The subject has had a myocardial infarction either non-ST elevation or ST elevation myocardial infarction within 90 days prior to consent with or without intervention\n3. The subject had or is planning to have any cardiac (e.g. cardioversion, coronary angiogram, percutaneous coronary intervention, cardiac ablation, etc.) or non-cardiac invasive or surgical procedure (e.g. cataract surgery, endoscopy, etc.) within 30 days prior or 45 days after the BSJ003W implant\n4. The subject has a history of atrial septal repair or has an atrial septal defect/persistent foramen ovale device\n5. The subject has an implanted mechanical valve prosthesis in any position\n6. The subject currently New York Heart Association class IV congestive heart failure\n7. The subject is contraindicated to aspirin\n8. The subject is contraindicated or seriously allergic to thienopyridine\n9. The subject is of childbearing potential and is, or plans to become pregnant during the time of the study\n10. The subject is not able and willing to return for required follow-up visits and examinations\n11. Subjects who are currently enrolled in another investigational study (of which primary endpoint follow-up have not been completed yet).\n12. The subject has other reason not to be eligible for this study per investigators' discretion."}, 'identificationModule': {'nctId': 'NCT03033134', 'acronym': 'SALUTE', 'briefTitle': 'A Study to Evaluate the Safety and Effectiveness of the Left Atrial Appendage Closure Therapy Using BSJ003W', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Japan K.K.'}, 'officialTitle': 'A Study to Evaluate the Safety and Effectiveness of the Left Atrial Appendage Closure Therapy Using BSJ003W for Patients With Non-valvular Atrial Fibrillation at Increased Risk of ThromboEmbolism in Japanese Medical Environment (SALUTE)', 'orgStudyIdInfo': {'id': 'S6001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BSJ003W', 'description': 'BSJ003W implant group', 'interventionNames': ['Device: BSJ003W']}], 'interventions': [{'name': 'BSJ003W', 'type': 'DEVICE', 'description': 'BSJ003W implant', 'armGroupLabels': ['BSJ003W']}]}, 'contactsLocationsModule': {'locations': [{'zip': '802-8255', 'city': 'Kitakyushu', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Kokura Memorial Hospital', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'zip': '305-8576', 'city': 'Tsukuba', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'University of Tsukuba Hospital', 'geoPoint': {'lat': 36.08333, 'lon': 140.11667}}, {'zip': '020-8505', 'city': 'Morioka', 'state': 'Iwate', 'country': 'Japan', 'facility': 'Iwate Medical University Hospital', 'geoPoint': {'lat': 39.7, 'lon': 141.15}}, {'zip': '247-8533', 'city': 'Kamakura', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Shonan Kamakura General Hospital', 'geoPoint': {'lat': 35.31085, 'lon': 139.54698}}, {'zip': '980-0873', 'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'Sendai Kousei Hospital', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '565-8565', 'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'facility': 'National Cerebral and Cardiovascular Center', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'zip': '113-8519', 'city': 'Bunkyo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Medical and Dental University Medical Hospital'}, {'zip': '183-0003', 'city': 'Fuchū', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Sakakibara Heart Institute', 'geoPoint': {'lat': 35.67452, 'lon': 139.48216}}, {'zip': '153-8515', 'city': 'Meguro-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Toho University Ohashi Medical Center'}, {'zip': '160-8582', 'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Keio University Hospital'}], 'overallOfficials': [{'name': 'Kazutaka Aonuma', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tsukuba University Hospital'}, {'name': 'Shigeru Saito', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shonankamakura General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The confidentiality of records/data obtained in the trial will remain anonymous for analysis and publication.\n\nThe information and data, obtained from the trial is used without personal identification'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Japan K.K.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}