Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-02-20 @ 6:40 PM
Study NCT ID:
NCT01634269
Status:
COMPLETED
Last Update Posted:
2019-10-15
First Post:
2012-07-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of MDT-2111 in Subjects With Small Aortic Annuli and Symptomatic Severe Aortic Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hiroko.ookubo@medtronic.com', 'phone': '81367760811', 'title': 'Hiroko Ookubo', 'organization': 'Medttronic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.', 'eventGroups': [{'id': 'EG000', 'title': 'Iliofemoral (As Treated Subjects)', 'description': 'The iliofemoral approach is used as the primary access site because there is a large body of clinical data in the past using this approach in patients implanted with Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system.', 'otherNumAtRisk': 16, 'otherNumAffected': 16, 'seriousNumAtRisk': 16, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Direct Aortic (As Treated Subjects)', 'description': 'For patients who would benefit from the therapy but have unfavorable non-aortic vasculature of the transfemoral and subclavian/axillary access sites (i.e. excessive atherosclerosis, calcifications, or tortuosity of arteries), the direct aortic approach is currently being used in overseas (EU and US) in clinical practice with similar outcomes to transfemoral and subclavian/ axillary artery approaches with the Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system.', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'All Subjects (As Treated Subjects)', 'description': 'This includes subjects from all access approaches, iliofemoral and direct aortic who were implanted with the Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system.', 'otherNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Anaemia Deficiencies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Anaemias Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lymphatic System Disorders Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cardiac Conduction Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Heart Failures Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rate And Rhythm Disorders Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Supraventricular Arrhythmias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Ventricular Arrhythmias And Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea (Excl Infective)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastrointestinal And Abdominal Pains (Excl Oral And Throat)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastrointestinal Atonic And Hypomotility Disorders Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea And Vomiting Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Administration Site Reactions Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Complications Associated With Device Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Device Physical Property And Chemical Issues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Febrile Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Implant And Catheter Site Reactions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Inflammations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Infusion Site Reactions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oedema Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pain And Discomfort Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hepatic And Hepatobiliary Disorders Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hepatic Enzymes And Function Abnormalities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Herpes Viral Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Infections Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Influenza Viral Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Upper Respiratory Tract Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary Tract Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fractures And Dislocations Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Non-Site Specific Injuries Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Non-Site Specific Procedural Complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Skin Injuries Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Spinal Fractures And Dislocations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Carbohydrate Tolerance Analyses (Incl Diabetes)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Liver Function Analyses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Metabolism Tests Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Mineral And Electrolyte Analyses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Platelet Analyses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Protein Analyses Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Renal Function Analyses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Skeletal And Cardiac Muscle Analyses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Tissue Enzyme Analyses Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vascular Tests Nec (Incl Blood Pressure)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'White Blood Cell Analyses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hyperlipidaemias Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lipid Metabolism And Deposit Disorders Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Potassium Imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Protein Metabolism Disorders Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Joint Related Signs And Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Muscle Related Signs And Symptoms Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Musculoskeletal And Connective Tissue Pain And Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Musculoskeletal And Connective Tissue Signs And Symptoms Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 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'Urinary Abnormalities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Breathing Abnormalities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Coughing And Associated Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, 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'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Haemorrhages Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lymphangiopathies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lymphoedemas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Peripheral Aneurysms And Dissections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vascular Hypotensive Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Aortic Valvular Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cardiac Conduction Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cardiac Disorders Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Heart Failures Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pericardial Disorders Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Supraventricular Arrhythmias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Blindness (Excl Colour Blindness)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cataract Conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Non-Site Specific Gastrointestinal Haemorrhages', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oesophageal Stenosis And Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Device Issues Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hepatic Fibrosis And Cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hepatocellular Damage And Hepatitis Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cardiac Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Influenza Viral Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lower Respiratory Tract And Lung Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Sepsis, Bacteraemia, Viraemia And Fungaemia Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Staphylococcal Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lower Limb Fractures And Dislocations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Skull Fractures, Facial Bone Fractures And Dislocations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Spinal Fractures And Dislocations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Total Fluid Volume Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Arthropathies Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Breast And Nipple Neoplasms Malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Central Nervous System Haemorrhages And Cerebrovascular Accidents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Breathing Abnormalities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pneumothorax And Pleural Effusions Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Aortic Necrosis And Vascular Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lymphangiopathies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Non-Site Specific Necrosis And Vascular Insufficiency Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Peripheral Embolism And Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Composite Score of Change in New York Heart Association (NYHA) Class and Effective Orifice Area (EOA).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.'}, {'id': 'OG001', 'title': 'Iliofemoral Implanted Subjects', 'description': 'The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}, {'value': '87.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG001'], 'paramType': 'Proportion of IF implanted subjects', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.0', 'paramValue': '87.5', 'ciLowerLimit': '61.7', 'ciUpperLimit': '98.4', 'statisticalMethod': 'Exact binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'baseline and 6 months', 'description': 'The primary endpoint is a composite of functional effectiveness as measured by improvement of at least 1 NYHA class from baseline to 6 months and anatomical effectiveness as measured by Effective Orifice Area (EOA) ≥1.0 cm² at 6 months.', 'unitOfMeasure': 'percentage of participants analyzed', 'reportingStatus': 'POSTED', 'populationDescription': 'Implanted subjects'}, {'type': 'SECONDARY', 'title': 'New York Heart Classification (NYHA) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.'}], 'classes': [{'title': 'NYHA I', 'categories': [{'measurements': [{'value': '45.0', 'groupId': 'OG000'}]}]}, {'title': 'NYHA II', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': 'NYHA III', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}]}]}, {'title': 'NYHA IV', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I: Subject with cardiac disease but without resulting limitations of physical activity.\n\nClass II: Subjects with cardiac disease resulting in slight limitation of physical activity.\n\nClass III: Subjects with cardiac disease resulting in marked limitation of physical activity.\n\nClass IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.', 'unitOfMeasure': 'percentage of participants analyzed', 'reportingStatus': 'POSTED', 'populationDescription': 'All Implanted Subjects'}, {'type': 'SECONDARY', 'title': 'New York Heart Classification (NYHA) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.'}], 'classes': [{'title': 'NYHA I', 'categories': [{'measurements': [{'value': '55.0', 'groupId': 'OG000'}]}]}, {'title': 'NYHA II', 'categories': [{'measurements': [{'value': '45.0', 'groupId': 'OG000'}]}]}, {'title': 'NYHA III', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'NYHA IV', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I: Subject with cardiac disease but without resulting limitations of physical activity.\n\nClass II: Subjects with cardiac disease resulting in slight limitation of physical activity.\n\nClass III: Subjects with cardiac disease resulting in marked limitation of physical activity.\n\nClass IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.', 'unitOfMeasure': 'percentage of participants analyzed', 'reportingStatus': 'POSTED', 'populationDescription': 'All Implanted Subjects'}, {'type': 'SECONDARY', 'title': 'New York Heart Classification (NYHA) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.'}], 'classes': [{'title': 'NYHA I', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}]}]}, {'title': 'NYHA II', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}]}]}, {'title': 'NYHA III', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'NYHA IV', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I: Subject with cardiac disease but without resulting limitations of physical activity.\n\nClass II: Subjects with cardiac disease resulting in slight limitation of physical activity.\n\nClass III: Subjects with cardiac disease resulting in marked limitation of physical activity.\n\nClass IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.', 'unitOfMeasure': 'percentage of participants analyzed', 'reportingStatus': 'POSTED', 'populationDescription': 'All Implanted Subjects'}, {'type': 'SECONDARY', 'title': 'New York Heart Classification (NYHA) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.'}], 'classes': [{'title': 'NYHA I', 'categories': [{'measurements': [{'value': '47.4', 'groupId': 'OG000'}]}]}, {'title': 'NYHA II', 'categories': [{'measurements': [{'value': '47.4', 'groupId': 'OG000'}]}]}, {'title': 'NYHA III', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'NYHA IV', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I: Subject with cardiac disease but without resulting limitations of physical activity.\n\nClass II: Subjects with cardiac disease resulting in slight limitation of physical activity.\n\nClass III: Subjects with cardiac disease resulting in marked limitation of physical activity.\n\nClass IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.', 'unitOfMeasure': 'percentage of participants analyzed', 'reportingStatus': 'POSTED', 'populationDescription': 'All Implanted Subjects'}, {'type': 'SECONDARY', 'title': 'Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'As Treated Subjects', 'description': 'The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 day to 30 days', 'description': 'MACCE is defined as a composite of:\n\n* all-cause death\n* myocardial infarction (MI)\n* all stroke, and\n* reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)', 'unitOfMeasure': 'prob of freedom from event @ 30 days', 'reportingStatus': 'POSTED', 'populationDescription': 'The Kaplan-Meier Method was used to calculate the number.'}, {'type': 'SECONDARY', 'title': 'Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'As Treated Subjects', 'description': 'The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 day to 6 months', 'description': 'MACCE is defined as a composite of:\n\n* all-cause death\n* myocardial infarction (MI)\n* all stroke, and\n* reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)', 'unitOfMeasure': 'prob of freedom from event @ 183 days', 'reportingStatus': 'POSTED', 'populationDescription': 'The Kaplan-Meier Method was used to calculate the number.'}, {'type': 'SECONDARY', 'title': 'Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'As Treated Subjects', 'description': 'The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 day to 12 months', 'description': 'MACCE is defined as a composite of:\n\n* all-cause death\n* myocardial infarction (MI)\n* all stroke, and\n* reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)', 'unitOfMeasure': 'prob of freedom from event @ 365 days', 'reportingStatus': 'POSTED', 'populationDescription': 'The Kaplan-Meier Method was used to calculate the number.'}, {'type': 'SECONDARY', 'title': 'Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'As Treated Subjects', 'description': 'The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 day to 24 months', 'description': 'MACCE is defined as a composite of:\n\n* all-cause death\n* myocardial infarction (MI)\n* all stroke, and\n* reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)', 'unitOfMeasure': 'prob of freedom from event @ 730 days', 'reportingStatus': 'POSTED', 'populationDescription': 'The Kaplan-Meier Method was used to calculate the number.'}, {'type': 'SECONDARY', 'title': 'Device Success as Defined in the Description.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'As Treated (AT) Subjects With Index Procedure', 'description': 'The (AT) population with Index Procedure was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo placed, or monitoring line placed. Index procedure was defined as introduction of the MDT-2111 TAV system delivery catheter.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after procedure or discharge', 'description': 'The following components must be satisfied for device success:\n\n1. successful vascular access, delivery and deployment of device and successful retrieval of delivery system\n2. correct position of device in the proper anatomical location\n3. EOA≥1.0 cm² AND mean gradient \\<20 mmHg or peak velocity \\<3 m/s, without moderate or severe AR\n4. only one valve implanted.', 'unitOfMeasure': 'percentage of participants analyzed', 'reportingStatus': 'POSTED', 'populationDescription': 'This includes subjects with an index procedure. Index procedure is defined as the first procedure that Medtronic MDT-2111 TAV system delivery catheter is introduced.'}, {'type': 'SECONDARY', 'title': 'Procedural Success, Defined as Device Success and Absence of In-hospital MACCE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'As Treated Subjects With Index Procedure', 'description': 'The (AT) population with Index Procedure was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo placed, or monitoring line placed. Index procedure was defined as introduction of the MDT-2111 TAV system delivery catheter.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from admission for procedure to discharge', 'description': 'Procedural success is defined as device success and absence of in-hospital MACCE.', 'unitOfMeasure': 'percent', 'reportingStatus': 'POSTED', 'populationDescription': 'This includes subjects with an index procedure. Index procedure is defined as the first procedure that Medtronic MDT-2111 TAV system delivery catheter is introduced.'}, {'type': 'SECONDARY', 'title': 'Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.8', 'spread': '4.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.1', 'spread': '7.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.2', 'spread': '5.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.7', 'spread': '5.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Echocardiographic Assessment of Prosthetic Valve Performance - Effective Orifice Area (EOA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '0.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'unitOfMeasure': 'cm²', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Echocardiographic Assessment of Prosthetic Valve Performance - Effective Orifice Area (EOA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '0.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'unitOfMeasure': 'cm²', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Echocardiographic Assessment of Prosthetic Valve Performance - Effective Orifice Area (EOA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '0.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'unitOfMeasure': 'cm²', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Echocardiographic Assessment of Prosthetic Valve Performance - Effective Orifice Area (EOA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '0.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'unitOfMeasure': 'cm²', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.5', 'spread': '6.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.8', 'spread': '5.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.5', 'spread': '7.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.9', 'spread': '4.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}]}]}, {'title': 'Trace', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'unitOfMeasure': 'percentage of participants analyzed', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Trace', 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '55.0', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'percentage of participants analyzed', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}]}]}, {'title': 'Trace', 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'unitOfMeasure': 'percentage of participants analyzed', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000'}]}]}, {'title': 'Trace', 'categories': [{'measurements': [{'value': '38.9', 'groupId': 'OG000'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'unitOfMeasure': 'percentage of participants analyzed', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Repeat Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'As Treated Subjects', 'description': 'The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 day to 30 days', 'unitOfMeasure': 'prob of freedom from event @ 30 days', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Repeat Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'As Treated Subjects', 'description': 'The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 day to 6 months', 'unitOfMeasure': 'prob of freedom from event @ 183 days', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Repeat Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'As Treated Subjects', 'description': 'The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 day to 12 months', 'unitOfMeasure': 'prob of freedom from event @ 365 days', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Repeat Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'As Treated Subjects', 'description': 'The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 day to 24 months', 'unitOfMeasure': 'prob of freedom from event @ 730 days', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Valve-related Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'As Treated Subjects', 'description': 'The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 day to 30 days', 'unitOfMeasure': 'prob of freedom from event @ 30 days', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Valve-related Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'As Treated Subjects', 'description': 'The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 day to 6 months', 'unitOfMeasure': 'prob of freedom from event @ 183 days', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Valve-related Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'As Treated Subjects', 'description': 'The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 day to 12 months', 'unitOfMeasure': 'prob of freedom from event @ 365 days', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Valve-related Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'As Treated Subjects', 'description': 'The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 day to 24 months', 'unitOfMeasure': 'prob of freedom from event @ 730 days', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '-12.2', 'upperLimit': '18.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 30 days', 'description': 'The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2 ͭ ͫ Scoring Program was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. The Z-score of each subdomain is calculated as the numbers of standard deviation away from the Japanese population mean of the corresponding raw score. Norm-based score is then derived as fifty plus 10 times of the z-score. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.', 'unitOfMeasure': 'points', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '-12.6', 'upperLimit': '16.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 6 months', 'description': 'The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2 ͭ ͫ Scoring Program was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. The Z-score of each subdomain is calculated as the numbers of standard deviation away from the Japanese population mean of the corresponding raw score. Norm-based score is then derived as fifty plus 10 times of the z-score. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.', 'unitOfMeasure': 'points', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '-9.5', 'upperLimit': '15.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 12 months', 'description': 'The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2 ͭ ͫ Scoring Program was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. The Z-score of each subdomain is calculated as the numbers of standard deviation away from the Japanese population mean of the corresponding raw score. Norm-based score is then derived as fifty plus 10 times of the z-score. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.', 'unitOfMeasure': 'points', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '-8.0', 'upperLimit': '19.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 24 months', 'description': 'The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2 ͭ ͫ Scoring Program was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. The Z-score of each subdomain is calculated as the numbers of standard deviation away from the Japanese population mean of the corresponding raw score. Norm-based score is then derived as fifty plus 10 times of the z-score. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.', 'unitOfMeasure': 'points', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MDT-2111 TAVI 23 mm', 'description': 'Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': '30 Days', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': '6 Month', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': '12 Month', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': '24 Month', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MDT-2111 TAVI 23 mm', 'description': 'Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '81.0', 'spread': '6.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'NYHA Class', 'classes': [{'title': 'NYHA Class II', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'NYHA Class III', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'NYHA IV', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Class II Subjects with cardiac disease resulting in slight limitation of physical activity. Class III Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.', 'unitOfMeasure': 'participants'}, {'title': 'STS Score', 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'spread': '3.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Society of Thoracic Surgeons (STS) risk model predicts the risk of operative mortality and morbidity after adult cardiac surgery on the basis of patient demographic and clinical variables. After information has been entered on a given case, the online STS risk calculator provides a risk percentage for each of the outcomes. The risk percentage estimates the chance of a specific outcome for a patient with the indicated risk factors. A higher score indicates a higher risk. A lower score indicates a lower risk.', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Logistic EuroScore', 'classes': [{'categories': [{'measurements': [{'value': '22.3', 'spread': '10.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The European System for Cardiac Operative Risk Evaluation (EuroSCORE) is a method of calculating predicted operative mortality for patients undergoing cardiac surgery. If a risk factor is present, a weight/number is assigned. The weights are added to give an approximate percent of predicted mortality. A higher score indicates a higher risk. A lower score indicates a lower risk.', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Surface Area', 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '0.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'm²', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-07', 'studyFirstSubmitDate': '2012-07-02', 'resultsFirstSubmitDate': '2016-04-27', 'studyFirstSubmitQcDate': '2012-07-02', 'lastUpdatePostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-04', 'studyFirstPostDateStruct': {'date': '2012-07-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite Score of Change in New York Heart Association (NYHA) Class and Effective Orifice Area (EOA).', 'timeFrame': 'baseline and 6 months', 'description': 'The primary endpoint is a composite of functional effectiveness as measured by improvement of at least 1 NYHA class from baseline to 6 months and anatomical effectiveness as measured by Effective Orifice Area (EOA) ≥1.0 cm² at 6 months.'}], 'secondaryOutcomes': [{'measure': 'New York Heart Classification (NYHA) Over Time', 'timeFrame': '30 days', 'description': 'NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I: Subject with cardiac disease but without resulting limitations of physical activity.\n\nClass II: Subjects with cardiac disease resulting in slight limitation of physical activity.\n\nClass III: Subjects with cardiac disease resulting in marked limitation of physical activity.\n\nClass IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.'}, {'measure': 'New York Heart Classification (NYHA) Over Time', 'timeFrame': '6 months', 'description': 'NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I: Subject with cardiac disease but without resulting limitations of physical activity.\n\nClass II: Subjects with cardiac disease resulting in slight limitation of physical activity.\n\nClass III: Subjects with cardiac disease resulting in marked limitation of physical activity.\n\nClass IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.'}, {'measure': 'New York Heart Classification (NYHA) Over Time', 'timeFrame': '12 months', 'description': 'NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I: Subject with cardiac disease but without resulting limitations of physical activity.\n\nClass II: Subjects with cardiac disease resulting in slight limitation of physical activity.\n\nClass III: Subjects with cardiac disease resulting in marked limitation of physical activity.\n\nClass IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.'}, {'measure': 'New York Heart Classification (NYHA) Over Time', 'timeFrame': '24 months', 'description': 'NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I: Subject with cardiac disease but without resulting limitations of physical activity.\n\nClass II: Subjects with cardiac disease resulting in slight limitation of physical activity.\n\nClass III: Subjects with cardiac disease resulting in marked limitation of physical activity.\n\nClass IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.'}, {'measure': 'Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)', 'timeFrame': '0 day to 30 days', 'description': 'MACCE is defined as a composite of:\n\n* all-cause death\n* myocardial infarction (MI)\n* all stroke, and\n* reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)'}, {'measure': 'Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)', 'timeFrame': '0 day to 6 months', 'description': 'MACCE is defined as a composite of:\n\n* all-cause death\n* myocardial infarction (MI)\n* all stroke, and\n* reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)'}, {'measure': 'Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)', 'timeFrame': '0 day to 12 months', 'description': 'MACCE is defined as a composite of:\n\n* all-cause death\n* myocardial infarction (MI)\n* all stroke, and\n* reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)'}, {'measure': 'Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)', 'timeFrame': '0 day to 24 months', 'description': 'MACCE is defined as a composite of:\n\n* all-cause death\n* myocardial infarction (MI)\n* all stroke, and\n* reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)'}, {'measure': 'Device Success as Defined in the Description.', 'timeFrame': 'after procedure or discharge', 'description': 'The following components must be satisfied for device success:\n\n1. successful vascular access, delivery and deployment of device and successful retrieval of delivery system\n2. correct position of device in the proper anatomical location\n3. EOA≥1.0 cm² AND mean gradient \\<20 mmHg or peak velocity \\<3 m/s, without moderate or severe AR\n4. only one valve implanted.'}, {'measure': 'Procedural Success, Defined as Device Success and Absence of In-hospital MACCE', 'timeFrame': 'from admission for procedure to discharge', 'description': 'Procedural success is defined as device success and absence of in-hospital MACCE.'}, {'measure': 'Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient', 'timeFrame': '30 days'}, {'measure': 'Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient', 'timeFrame': '6 months'}, {'measure': 'Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient', 'timeFrame': '12 months'}, {'measure': 'Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient', 'timeFrame': '24 months'}, {'measure': 'Echocardiographic Assessment of Prosthetic Valve Performance - Effective Orifice Area (EOA)', 'timeFrame': '30 days'}, {'measure': 'Echocardiographic Assessment of Prosthetic Valve Performance - Effective Orifice Area (EOA)', 'timeFrame': '6 months'}, {'measure': 'Echocardiographic Assessment of Prosthetic Valve Performance - Effective Orifice Area (EOA)', 'timeFrame': '12 months'}, {'measure': 'Echocardiographic Assessment of Prosthetic Valve Performance - Effective Orifice Area (EOA)', 'timeFrame': '24 months'}, {'measure': 'Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': '30 days'}, {'measure': 'Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': '6 months'}, {'measure': 'Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': '12 months'}, {'measure': 'Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': '24 months'}, {'measure': 'Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR)', 'timeFrame': '30 days'}, {'measure': 'Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR)', 'timeFrame': '6 months'}, {'measure': 'Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR)', 'timeFrame': '12 months'}, {'measure': 'Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR)', 'timeFrame': '24 months'}, {'measure': 'Repeat Hospitalization', 'timeFrame': '0 day to 30 days'}, {'measure': 'Repeat Hospitalization', 'timeFrame': '0 day to 6 months'}, {'measure': 'Repeat Hospitalization', 'timeFrame': '0 day to 12 months'}, {'measure': 'Repeat Hospitalization', 'timeFrame': '0 day to 24 months'}, {'measure': 'Valve-related Deaths', 'timeFrame': '0 day to 30 days'}, {'measure': 'Valve-related Deaths', 'timeFrame': '0 day to 6 months'}, {'measure': 'Valve-related Deaths', 'timeFrame': '0 day to 12 months'}, {'measure': 'Valve-related Deaths', 'timeFrame': '0 day to 24 months'}, {'measure': 'Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline)', 'timeFrame': 'Baseline to 30 days', 'description': 'The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2 ͭ ͫ Scoring Program was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. The Z-score of each subdomain is calculated as the numbers of standard deviation away from the Japanese population mean of the corresponding raw score. Norm-based score is then derived as fifty plus 10 times of the z-score. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.'}, {'measure': 'Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline)', 'timeFrame': 'Baseline to 6 months', 'description': 'The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2 ͭ ͫ Scoring Program was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. The Z-score of each subdomain is calculated as the numbers of standard deviation away from the Japanese population mean of the corresponding raw score. Norm-based score is then derived as fifty plus 10 times of the z-score. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.'}, {'measure': 'Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline)', 'timeFrame': 'Baseline to 12 months', 'description': 'The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2 ͭ ͫ Scoring Program was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. The Z-score of each subdomain is calculated as the numbers of standard deviation away from the Japanese population mean of the corresponding raw score. Norm-based score is then derived as fifty plus 10 times of the z-score. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.'}, {'measure': 'Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline)', 'timeFrame': 'Baseline to 24 months', 'description': 'The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2 ͭ ͫ Scoring Program was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. The Z-score of each subdomain is calculated as the numbers of standard deviation away from the Japanese population mean of the corresponding raw score. Norm-based score is then derived as fifty plus 10 times of the z-score. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Valvular Heart Disease', 'Severe Aortic Stenosis', 'Aortic Valve Replacement'], 'conditions': ['Aortic Valve Stenosis']}, 'referencesModule': {'references': [{'pmid': '28321003', 'type': 'DERIVED', 'citation': 'Sawa Y, Torikai K, Kobayashi J, Niinami H, Kuratani T, Maeda K, Kanzaki H, Komiyama N, Tanaka Y, Zhang A, Saito S. Midterm Outcomes With a Self-Expandable Transcatheter Heart Valve in Japanese Patients With Symptomatic Severe Aortic Stenosis. Circ J. 2017 Jul 25;81(8):1108-1115. doi: 10.1253/circj.CJ-17-0112. Epub 2017 Mar 17.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the present trial is to demonstrate the safety and effectiveness of the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects with small aortic annuli and deemed difficult for surgical operation.', 'detailedDescription': 'The purpose of this trial is to evaluate the effectiveness and safety of the MDT-2111 TAV system in subjects with small annuli and symptomatic severe AS deemed difficult for surgical intervention. The primary endpoint is a composite of functional effectiveness as measured by improvement of at least 1 New York Heart Association (NYHA) class from baseline to 6 months and anatomical effectiveness as measured by Effective Orifice Area (EOA) ≥1.0 cm² at 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject must have co-morbidities such that one cardiologist and one cardiac surgeon agree that medical factors preclude operation, based on a conclusion that the probability of death or serious morbidity exceeds the probability of meaningful improvement.\n2. Subject has senile degenerative aortic valve stenosis with:\n\n mean gradient \\> 40 mmHg or jet velocity greater than 4.0 m/s by either resting or dobutamine stress echocardiogram, or simultaneous pressure recordings at cardiac catheterization (either resting or dobutamine stress), AND an initial aortic valve area of ≤ 0.8 cm² (or aortic valve area index ≤ 0.5 cm²/m²) by resting echocardiogram.\n3. Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class Class III or greater. If screening committee agrees the eligibility of a patient with class II , based on medical factors, he/she can be enrolled.\n4. Patient has been informed of the nature of the trial and has signed an Informed Consent Form.\n5. Patient agrees to comply with specified follow-up evaluations and to return to the same investigational site where the procedure was performed.\n\nExclusion Criteria:\n\n1. Evidence of an acute myocardial infarction ≤ 30 days prior to the intended treatment.\n2. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the procedure.\n3. Blood dyscrasias as defined:\n\n * Leukopenia (WBC count \\< 1,000 cells/mm³)\n * Thrombocytopenia (platelet count \\<50,000 cells/mm³)\n * History of bleeding diathesis or coagulopathy\n * Hypercoagulable states\n4. Untreated clinically significant coronary artery disease requiring revascularization.\n5. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.\n6. Need for emergency surgery for any reason.\n7. Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) \\< 20% as measured by resting echocardiogram.\n8. Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack(TIA).\n9. End stage renal disease requiring chronic dialysis.\n10. GI bleeding within the past 3 months.\n11. A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated:\n\n * Aspirin\n * Ticlopidine\n * Heparin\n * Contrast media\n * Nitinol (titanium and nickel alloy)\n12. Ongoing sepsis, including active endocarditis.\n13. Subject refuses a blood transfusion.\n14. Life expectancy \\< 12 months due to associated non-cardiac co-morbid conditions.\n15. Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.\n16. Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).\n17. Currently participating in an investigational drug or another device trial. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.\n18. Symptomatic carotid or vertebral artery disease.\n19. Native aortic annulus size \\< 18 mm or \\> 20 mm per the screening diagnostic imaging.\n20. Pre-existing prosthetic heart valve in any position.\n21. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation).\n22. Mitral regurgitation (moderate to severe) or severe tricuspid regurgitation.\n23. Moderate to severe mitral stenosis.\n24. Hypertrophic obstructive cardiomyopathy.\n25. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.\n26. Severe basal septal hypertrophy with an outflow gradient.\n27. Ascending aorta diameter \\> 34 mm\n28. Congenital bicuspid or unicuspid valve verified by echocardiography.\n29. For patients with native coronary artery dependent circulation:\n\n * Sinus of valsalva width \\< 25 mm OR\n * Height of the left or right coronary sinus of valsalva (to the tubular aorta) \\< 15mm.\n30. Femoral or iliac artery of the first choice corresponding to any one of the following:\n\n * Angle at aortic root (the angle between aortic valve annulus plane and horizontal plane/vertebra) exceeds 70°.\n * Vessel diameter of femoral or iliac artery is less than 6 mm.\n * Aorta has severe calcification, excess tortuosity or severe atherosclerosis.\n * Transarterial access not able to accommodate an 18Fr sheath.\n31. Subclavian artery of the second choice corresponding to any one of the following:\n\n * Angle at aortic root (the angle between aortic valve annulus plane and horizontal plane/vertebra) exceeds 70° (in the case of left subclavian artery) and 30° (in the case of right subclavian artery).\n * Vessel diameter of subclavian artery is less than 6 mm.\n * Transarterial access not able to accommodate an 18Fr sheath.\n32. Direct Aortic Artery as third line choice of access. Patients are excluded from Direct Aortic access if:\n\n * Access site is less than 6 cm from the aortic valve basal plane\n * Access site has calcification or porcelain aorta\n * Access site and delivery trajectory contain RIMA or patent RIMA graft'}, 'identificationModule': {'nctId': 'NCT01634269', 'briefTitle': 'Clinical Evaluation of MDT-2111 in Subjects With Small Aortic Annuli and Symptomatic Severe Aortic Stenosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiovascular'}, 'officialTitle': 'Medtronic MDT-2111 CoreValve Japan 23mm Study', 'orgStudyIdInfo': {'id': 'MDT-2111 23 mm trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MDT-2111 TAVI 23 mm', 'description': 'Subjects with small annuli and symptomatic severe AS deemed difficult for surgical intervention.', 'interventionNames': ['Device: MDT-2111 TAVI 23 mm']}], 'interventions': [{'name': 'MDT-2111 TAVI 23 mm', 'type': 'DEVICE', 'description': 'Device: 23 mm MDT-2111 System for Transcatheter Aortic Valve Implantation (TAVI) Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system.', 'armGroupLabels': ['MDT-2111 TAVI 23 mm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kamakura', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Shonan Kamakura General Hospital', 'geoPoint': {'lat': 35.31085, 'lon': 139.54698}}, {'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'facility': 'National Cerebral and Cardiovascular Center', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka University Hospital', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'city': 'Hidaka', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Saitama Medical University', 'geoPoint': {'lat': 35.91664, 'lon': 139.36233}}], 'overallOfficials': [{'name': 'Yoshi Sawa, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Osaka University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiovascular', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}