Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-03-24 @ 11:58 AM
Study NCT ID:
NCT03055858
Status:
COMPLETED
Last Update Posted:
2025-02-11
First Post:
2017-02-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
AMPLATZER Duct Occluder II Additional Sizes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D004374', 'term': 'Ductus Arteriosus, Patent'}], 'ancestors': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Ebony.Kargbo@abbott.com', 'phone': '612-209-8185', 'title': 'Ebony Kargbo', 'organization': 'Abbott Laboratories'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'PDA Closure', 'description': 'ADO II AS (PDA closure): Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).', 'otherNumAtRisk': 200, 'deathsNumAtRisk': 200, 'otherNumAffected': 26, 'seriousNumAtRisk': 200, 'deathsNumAffected': 9, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Device Embolization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pulmonary Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Respiratory Compromise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anemia Requiring Transfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hoarse Cry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tissue from Left Side of Atrial Septum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Obstruction of The Pulmonary Artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Valve Damage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Valvular Regurgitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vascular Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vessel Damage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Deterioration in Resp Status', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Right bundle branch block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Procedural Blood Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Coarctation of Aorta', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Obstruction of The Aorta', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pulmonary Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Desaturation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Device Migration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Death Related to Liver Failure and Chronic Lung Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Progressive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Respiratory Compromise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Necrotizing Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Device Embolization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Left Vocal Cord Paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety Endpoint: The Rate of Major Complications After an Attempted ADO II AS Device Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PDA Closure', 'description': 'ADO II AS (PDA closure): Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).'}], 'classes': [{'title': 'IDE Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '7.11'}]}]}, {'title': 'CAP Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '0.76', 'upperLimit': '6.96'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through 180 days', 'description': 'Major complications are defined as device (ADO II AS) or procedure-related adverse events resulting in any of the following:\n\n* death,\n* life-threatening adverse event,\n* persistent or significant disability/incapacity, and/or\n* a major open surgical intervention which is performed by a surgeon under general anesthesia', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150). The analysis population included the subjects who were available at the time of evaluation.'}, {'type': 'PRIMARY', 'title': 'Effectiveness Endpoint: The Rate of Effective Closure of the Ductus Arteriosus Among Subjects With a Successful ADO II AS Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PDA Closure', 'description': 'ADO II AS (PDA closure): Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).'}], 'classes': [{'title': 'IDE Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '91.96', 'upperLimit': '100.00'}]}]}, {'title': 'CAP Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000', 'lowerLimit': '95.76', 'upperLimit': '99.98'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the 6-month follow-up', 'description': 'The primary effectiveness endpoint is the rate of effective closure of the ductus arteriosus among subjects with a successful ADO II AS implant as assessed by the presence of either a Grade 0 (none) or Grade 1 (trivial) shunt at the 6-month follow-up by transthoracic echocardiography (TTE).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150). The analysis population included the subjects who were available at the time of evaluation.'}, {'type': 'SECONDARY', 'title': 'The Rate of Significant Obstruction of the Pulmonary Artery or Aorta', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PDA Closure', 'description': 'ADO II AS (PDA closure): Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).'}], 'classes': [{'title': 'IDE Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '12.86'}]}]}, {'title': 'CAP Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '2.80'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through 6 month follow-up visit', 'description': 'The rate of significant obstruction of the pulmonary artery or aorta through the 6-month follow-up visit per the following definitions:\n\n1. Significant obstruction of the left pulmonary artery is defined as less than 30% flow to the left lung by lung perfusion scan or a peak instantaneous gradient in left pulmonary artery ≥35 mmHg by echocardiogram if lung perfusion scan is not available. OR\n2. Significant obstruction of the aorta is defined as a gradient of ≥20 mmHg in the aortic isthmus by invasive aortic catheterization or a mean gradient ≥20 mmHg in the aortic isthmus by echocardiogram if invasive aortic catheterization is not available.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150). The analysis population included the subjects who were available at the time of evaluation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PDA Closure', 'description': 'ADO II AS (PDA closure): Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}]}, {'type': 'IDE', 'achievements': [{'groupId': 'FG000', 'numSubjects': '136'}]}, {'type': 'CAP', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '156'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Missed Follow-Up Visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}]}]}], 'recruitmentDetails': 'A total of 50 subjects were enrolled in the ADO II AS IDE study at 8 centers in the United States between 5 June 2017 and 25 January 2018. Following completion of enrollment in the IDE cohort, an additional 150 subjects were enrolled in the continued access protocol (CAP) between 26 March 2018 and 1 February 2019.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PDA Closure', 'description': 'ADO II AS (PDA closure): Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'IDE Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '16.37', 'spread': '32.45', 'groupId': 'BG000'}]}]}, {'title': 'CAP Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13.10', 'spread': '34.23', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150)'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'IDE Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': 'CAP Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '69', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '81', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150)'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'IDE Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'CAP Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '129', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'IDE Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'CAP Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '57', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150)'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '200', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'PDA Length', 'classes': [{'title': 'IDE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '8.28', 'spread': '2.70', 'groupId': 'BG000'}]}]}, {'title': 'CAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '9.51', 'spread': '2.98', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150)'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-02', 'size': 1301293, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-18T00:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'ADO II AS device'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2017-02-14', 'resultsFirstSubmitDate': '2020-07-14', 'studyFirstSubmitQcDate': '2017-02-15', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-01', 'studyFirstPostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety Endpoint: The Rate of Major Complications After an Attempted ADO II AS Device Implant', 'timeFrame': 'Through 180 days', 'description': 'Major complications are defined as device (ADO II AS) or procedure-related adverse events resulting in any of the following:\n\n* death,\n* life-threatening adverse event,\n* persistent or significant disability/incapacity, and/or\n* a major open surgical intervention which is performed by a surgeon under general anesthesia'}, {'measure': 'Effectiveness Endpoint: The Rate of Effective Closure of the Ductus Arteriosus Among Subjects With a Successful ADO II AS Implant', 'timeFrame': 'At the 6-month follow-up', 'description': 'The primary effectiveness endpoint is the rate of effective closure of the ductus arteriosus among subjects with a successful ADO II AS implant as assessed by the presence of either a Grade 0 (none) or Grade 1 (trivial) shunt at the 6-month follow-up by transthoracic echocardiography (TTE).'}], 'secondaryOutcomes': [{'measure': 'The Rate of Significant Obstruction of the Pulmonary Artery or Aorta', 'timeFrame': 'Through 6 month follow-up visit', 'description': 'The rate of significant obstruction of the pulmonary artery or aorta through the 6-month follow-up visit per the following definitions:\n\n1. Significant obstruction of the left pulmonary artery is defined as less than 30% flow to the left lung by lung perfusion scan or a peak instantaneous gradient in left pulmonary artery ≥35 mmHg by echocardiogram if lung perfusion scan is not available. OR\n2. Significant obstruction of the aorta is defined as a gradient of ≥20 mmHg in the aortic isthmus by invasive aortic catheterization or a mean gradient ≥20 mmHg in the aortic isthmus by echocardiogram if invasive aortic catheterization is not available.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['PDA', 'SJM-CIP-10171', 'ADO II AS', 'IDE', 'CAP'], 'conditions': ['Patent Ductus Arteriosus']}, 'referencesModule': {'references': [{'pmid': '37587183', 'type': 'DERIVED', 'citation': 'Morray BH, Sathanandam SK, Forbes T, Gillespie M, Berman D, Armstrong AK, Shahanavaz S, Jones T, Rockefeller T, Justino H, Nykanen D, Weiler C, Gutfinger D, Zahn EM. 3-year follow-up of a prospective, multicenter study of the Amplatzer Piccolo Occluder for transcatheter patent ductus arteriosus closure in children >/= 700 grams. J Perinatol. 2023 Oct;43(10):1238-1244. doi: 10.1038/s41372-023-01741-1. Epub 2023 Aug 16.'}, {'pmid': '32433821', 'type': 'DERIVED', 'citation': "Sathanandam SK, Gutfinger D, O'Brien L, Forbes TJ, Gillespie MJ, Berman DP, Armstrong AK, Shahanavaz S, Jones TK, Morray BH, Rockefeller TA, Justino H, Nykanen DG, Zahn EM. Amplatzer Piccolo Occluder clinical trial for percutaneous closure of the patent ductus arteriosus in patients >/=700 grams. Catheter Cardiovasc Interv. 2020 Nov;96(6):1266-1276. doi: 10.1002/ccd.28973. Epub 2020 May 20."}]}, 'descriptionModule': {'briefSummary': 'The ADO II AS Study is a single arm, prospective, multicenter, nonrandomized clinical investigation to characterize the safety and effectiveness of the ADO II AS device in patients with a patent ductus arteriosus (PDA). Subjects will be implanted with the ADO II AS device using a transcatheter femoral vessel approach under fluoroscopic and echocardiographic guidance.\n\nTo account for subject dropout, up to 50 subjects will be enrolled in this clinical investigation. Up to an additional 150 subjects may be enrolled under continued access. The clinical investigation will be conducted at up to 10 centers in the United States.\n\nSubjects participating in this clinical investigation will be followed for 3 years. The expected duration of enrollment is 18 months. The total duration of the clinical investigation is expected to be 4.5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Days', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of a PDA\n* PDA ≤ 4mm in diameter\n* PDA ≥ 3mm in length\n* Subject (or legally authorized representative) is willing to comply with all pre-procedure, post-procedure, and follow-up testing requirements and provides consent to participate in the clinical study\n\nNOTE: This study is enrolling children and all local laws and governing IRB requirements will be followed for obtaining informed consent\n\nExclusion Criteria:\n\n* Weight \\< 700 grams at time of the procedure\n* Age \\< 3 days at time of procedure\n* Coarctation of the aorta\n* Left pulmonary artery stenosis\n* Cardiac output that is dependent on right to left shunt through the patent ductus arteriosus due to pulmonary hypertension\n* Intracardiac thrombus\n* Active infection requiring treatment at the time of implant\n* Female subjects of child bearing potential are either pregnant or desire to become pregnant within six months post implant\n* Other disease process likely to limit survival to less than six (6) months\n* Participating in another study for an investigational drug and/or device that may clinically interfere with this study's endpoints"}, 'identificationModule': {'nctId': 'NCT03055858', 'acronym': 'ADO II AS', 'briefTitle': 'AMPLATZER Duct Occluder II Additional Sizes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'AMPLATZER Duct Occluder II Additional Sizes Clinical Study', 'orgStudyIdInfo': {'id': 'SJM-CIP-10171'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PDA closure', 'interventionNames': ['Device: ADO II AS (PDA closure)']}], 'interventions': [{'name': 'ADO II AS (PDA closure)', 'type': 'DEVICE', 'description': 'Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).', 'armGroupLabels': ['PDA closure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Arnold Palmer Hospital', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': "Children's Hospital of Michigan", 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Louis Children's Hospital", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Methodist LeBonheur Healthcare', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Evan Zahn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}