Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-02-25 @ 9:50 PM
Study NCT ID:
NCT03016169
Status:
COMPLETED
Last Update Posted:
2025-02-11
First Post:
2016-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trifecta™ GT Post Market Clinical Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'karine.miquel@abbott.com', 'phone': '+32 479 600 107', 'title': 'Karine Miquel, Associate Director of Project Management', 'organization': 'Abbott'}, 'certainAgreement': {'otherDetails': 'The PI may not publish study results until publication of results of multi center study or 2 years after study completion, whichever is sooner. PI allows Sponsor to review any proposed publication at least 40 days before forwarding it to any person that is not bound by confidentiality agreement between Sponsor and PI. Sponsor can request delay publication for no more than 120 days to allow Sponsor to file patent applications or take other measures to preserve or secure its Intellectual Property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '5 Years', 'description': 'All AEs reported in the Trifecta GT PMCF study.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment', 'description': 'All subjects will receive the Trifecta GT valve\n\nTrifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve.', 'otherNumAtRisk': 358, 'deathsNumAtRisk': 358, 'otherNumAffected': 82, 'seriousNumAtRisk': 358, 'deathsNumAffected': 54, 'seriousNumAffected': 206}], 'otherEvents': [{'term': 'OTHER CARDIOVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'NONSTRUCTURAL DYSFUNCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER CARDIOVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 42}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'STRUCTURAL VALVE DETERIORATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'MAJOR BLEEDING - GASTROINTESTINAL BLEED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER CARDIOVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'NONSTRUCTURAL DYSFUNCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'MAJOR BLEEDING - OTHER BLEEDING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER CARDIOVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER CARDIOVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}], 'seriousEvents': [{'term': 'MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'MAJOR BLEEDING - OTHER BLEEDING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER CARDIOVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'ENDOCARDITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'NONSTRUCTURAL DYSFUNCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER CARDIOVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 83}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'STRUCTURAL VALVE DETERIORATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'MAJOR BLEEDING - GASTROINTESTINAL BLEED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER CARDIOVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 7}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'ENDOCARDITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER CARDIOVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'MAJOR BLEEDING - OTHER BLEEDING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER CARDIOVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER CARDIOVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 26}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'MAJOR BLEEDING - OTHER BLEEDING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER CARDIOVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'MAJOR BLEEDING - UROLOGIC BLEEDING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 18}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER CARDIOVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 31}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 4}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'MAJOR BLEEDING - OTHER BLEEDING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER CARDIOVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}, {'term': 'OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Freedom From Surgical Valve Replacement or Transcatheter Valve-in-Valve Implantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'All subjects will receive the Trifecta GT valve\n\nTrifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.8', 'groupId': 'OG000', 'lowerLimit': '92.8', 'upperLimit': '97.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years post implant', 'description': 'Estimated percentage of participants free from undergoing an additional aortic valve replacement within 5 years, using a Kaplan-Meier estimate.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes participants implanted with the Trifecta™ valve in the study on 10 March 2017 and continued through 05 February 2018.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Freedom From All-cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'All subjects will receive the Trifecta GT valve.\n\nTrifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.5', 'groupId': 'OG000', 'lowerLimit': '80.2', 'upperLimit': '88.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years post implant', 'description': 'Estimated percentage of participants surviving at 5 years, using a Kaplan-Meier estimate.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes participants implanted with the Trifecta™ valve in the study on 10 March 2017 and continued through 05 February 2018'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Freedom From Valve Related Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'All subjects will receive the Trifecta GT valve.\n\nTrifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.4', 'groupId': 'OG000', 'lowerLimit': '92.3', 'upperLimit': '97.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years post implant', 'description': 'Estimated percentage of participants remaining free from a valve-related death at 5 years, using a Kaplan-Meier estimate. The estimate includes subjects alive at 5 years and subjects who died for reasons unrelated to the valve at 5 years.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes participants implanted with the Trifecta™ valve in the study on 10 March 2017 and continued through 05 February 2018.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Freedom From Structural Valve Deterioration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'All subjects will receive the Trifecta GT valve.\n\nTrifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.2', 'groupId': 'OG000', 'lowerLimit': '93.3', 'upperLimit': '97.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years post implant', 'description': 'Estimated percentage of participants free from structural valve deterioration at 5 years, as using a Kaplan-Meier estimate. Structural valve deterioration is any change in function of the valve resulting in an intrinsic abnormality of the valve that causes stenosis or regurgitation.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes participants implanted with the Trifecta™ valve in the study on 10 March 2017 and continued through 05 February 2018.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Freedom From Surgical Valve Replacement or Transcatheter Valve Implantation Due to Structural Valve Deterioration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'All subjects will receive the Trifecta GT valve.\n\nTrifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000', 'lowerLimit': '95.8', 'upperLimit': '99.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years post implant', 'description': 'Estimated percentage of participants who do not require surgery due to structural valve deterioration, using a Kaplan-Meier estimate.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes participants implanted with the Trifecta™ valve in the study on 10 March 2017 and continued through 05 February 2018.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Valve Hemodynamic Performance for Left Ventricular Ejection Fraction (LVEF) at Six Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'All subjects will receive the Trifecta GT valve.\n\nTrifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.4', 'spread': '7.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Months', 'description': 'LVEF is a measurement of the percentage of blood leaving the heart each time it contracts.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes all study participants with an LVEF assessment at 6 months.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Valve Hemodynamic Performance for Effective Orifice Area (EOA) at Six Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'All subjects will receive the Trifecta GT valve.\n\nTrifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '0.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Months', 'description': 'EOA measures the functional valve opening for blood flow through the valve.', 'unitOfMeasure': 'cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes all study participants with an EOA assessment at 6 months.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Valve Hemodynamic Performance for Indexed Effective Orifice Area (iEOA) at Six Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'All subjects will receive the Trifecta GT valve.\n\nTrifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '0.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Months', 'description': "iEOA adjusts the EOA measurement to the patient's body size.", 'unitOfMeasure': 'cm^2/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes all study participants with an iEOA assessment at 6 months.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Valve Hemodynamic Performance for Mean Gradient at Six Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'All subjects will receive the Trifecta GT valve.\n\nTrifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'spread': '3.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Months', 'description': 'Mean Gradient measures the average pressure difference across the valve during blood flow.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes all study participants with a mean gradient assessment at 6 months.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Valve Hemodynamic Performance for Peak Gradient at Six Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'All subjects will receive the Trifecta GT valve.\n\nTrifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.6', 'spread': '6.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Months', 'description': 'Peak Gradient measures the maximum pressure difference across the valve during blood flow.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes all study participants with a peak gradient assessment at 6 months.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': 'All subjects will receive the Trifecta GT valve.\n\nTrifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '358'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '269'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '54'}]}, {'type': 'Device Explant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'Other Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 358 subjects were enrolled across 27 investigational sites in 12 North American and European countries. The Trifecta GT PMCF study is a single-arm, prospective, multi-center clinical investigation designed to evaluate the five-year safety and performance of the Trifecta GT valve in patients indicated for aortic valve replacement.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment', 'description': 'All subjects will receive the Trifecta GT valve\n\nTrifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '70.8', 'spread': '7.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '140', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '218', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Hypertension', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '291', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-15', 'size': 2005107, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-01-25T07:02', 'hasProtocol': True}, {'date': '2022-06-10', 'size': 730554, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-01-25T07:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 358}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2016-12-21', 'resultsFirstSubmitDate': '2024-03-05', 'studyFirstSubmitQcDate': '2017-01-06', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-01', 'studyFirstPostDateStruct': {'date': '2017-01-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Freedom From All-cause Mortality', 'timeFrame': '5 years post implant', 'description': 'Estimated percentage of participants surviving at 5 years, using a Kaplan-Meier estimate.'}, {'measure': 'Freedom From Valve Related Mortality', 'timeFrame': '5 years post implant', 'description': 'Estimated percentage of participants remaining free from a valve-related death at 5 years, using a Kaplan-Meier estimate. The estimate includes subjects alive at 5 years and subjects who died for reasons unrelated to the valve at 5 years.'}, {'measure': 'Freedom From Structural Valve Deterioration', 'timeFrame': '5 years post implant', 'description': 'Estimated percentage of participants free from structural valve deterioration at 5 years, as using a Kaplan-Meier estimate. Structural valve deterioration is any change in function of the valve resulting in an intrinsic abnormality of the valve that causes stenosis or regurgitation.'}, {'measure': 'Freedom From Surgical Valve Replacement or Transcatheter Valve Implantation Due to Structural Valve Deterioration', 'timeFrame': '5 years post implant', 'description': 'Estimated percentage of participants who do not require surgery due to structural valve deterioration, using a Kaplan-Meier estimate.'}, {'measure': 'Valve Hemodynamic Performance for Left Ventricular Ejection Fraction (LVEF) at Six Months', 'timeFrame': '6 Months', 'description': 'LVEF is a measurement of the percentage of blood leaving the heart each time it contracts.'}, {'measure': 'Valve Hemodynamic Performance for Effective Orifice Area (EOA) at Six Months', 'timeFrame': '6 Months', 'description': 'EOA measures the functional valve opening for blood flow through the valve.'}, {'measure': 'Valve Hemodynamic Performance for Indexed Effective Orifice Area (iEOA) at Six Months', 'timeFrame': '6 Months', 'description': "iEOA adjusts the EOA measurement to the patient's body size."}, {'measure': 'Valve Hemodynamic Performance for Mean Gradient at Six Months', 'timeFrame': '6 Months', 'description': 'Mean Gradient measures the average pressure difference across the valve during blood flow.'}, {'measure': 'Valve Hemodynamic Performance for Peak Gradient at Six Months', 'timeFrame': '6 Months', 'description': 'Peak Gradient measures the maximum pressure difference across the valve during blood flow.'}], 'primaryOutcomes': [{'measure': 'Freedom From Surgical Valve Replacement or Transcatheter Valve-in-Valve Implantation', 'timeFrame': '5 years post implant', 'description': 'Estimated percentage of participants free from undergoing an additional aortic valve replacement within 5 years, using a Kaplan-Meier estimate.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Aortic Valve Disease', 'Aortic Valve Disorder']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the safety and performance of the Trifecta™ GT (Glide Technology) valve through 5 year follow-up in a prospective, multi-center, real-world setting. This study is intended to satisfy post-market clinical follow-up requirements of CE Mark in Europe.', 'detailedDescription': 'The study is a prospective multi-center evaluation of approximately 350 subjects implanted with a St. Jude Medical (SJM) Trifecta™ GT valve. It will be conducted in approximately 35 sites worldwide.\n\nSubjects will be followed for 5 years. The total duration of the study is expected to be 6 years, assuming all subjects are enrolled within 1 year of study initiation. To ensure enrollment balance across sites, no individual site can enroll more than 10% of the sample size (n=35 subjects) without prior approval from the sponsor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is a candidate for surgical aortic valve replacement per current guidelines and is intended to be implanted with a St. Jude Medical Trifecta GT valve.\n2. Subject is of legal age in the country where the subject is enrolled.\n3. Subject must be willing and able to provide written informed consent to participate in this study.\n4. Subject must be willing and able to comply with all follow-up requirements.\n\nExclusion Criteria:\n\n1. Subject undergoes a concomitant procedure of mitral or tricuspid valve replacement at the time of the Trifecta GT valve implantation surgery.\n2. Subject has contraindication for cardiac surgery.\n3. Subject is pregnant. Pregnancy will be assessed by the subject informing the physicians.\n4. Subject has active endocarditis (subjects who have previously experienced endocarditis must have two documented negative blood culture results while off antibiotic therapy prior to the valve implantation surgery).\n5. Subject has had a stroke or transient ischemic attack within 6 months prior to the planned valve implantation surgery.\n6. Subject is undergoing renal dialysis.\n7. Subject has a history of active drug addiction, active alcohol abuse, or psychiatric hospital admission for psychosis within the prior 2 years.\n8. Subject has a documented thrombus in the left atrium or left ventricle at the time of the valve implantation surgery.\n9. Subject has a left ventricular ejection fraction \\< 30%.\n10. Subject previously enrolled in the Trifecta GT PMCF study and withdrawn (a subject cannot be enrolled twice in this study).\n11. Preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm.\n12. Subject has a life expectancy less than 2 years.'}, 'identificationModule': {'nctId': 'NCT03016169', 'briefTitle': 'Trifecta™ GT Post Market Clinical Follow-up', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Trifecta™ GT (Glide Technology) Post Market Clinical Follow-up (PMCF)', 'orgStudyIdInfo': {'id': 'SJM-CIP-10120'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Treatment', 'description': 'All subjects will receive the Trifecta GT valve', 'interventionNames': ['Device: Trifecta GT (Glide Technology) Valve']}], 'interventions': [{'name': 'Trifecta GT (Glide Technology) Valve', 'type': 'DEVICE', 'description': 'Surgical aortic valve replacement with Trifecta GT Valve.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Mission Health & Hospitals', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '19096', 'city': 'Wynnewood', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Main Line Health Center/Lankenau Hospital', 'geoPoint': {'lat': 40.00289, 'lon': -75.27074}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Centennial Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "CHI St. Luke's Health Baylor College of Medicine", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '1200', 'city': 'Brussels', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'E2L4L2', 'city': 'Saint John', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Saint John Regional Hospital - New Brunswick Heart Centre', 'geoPoint': {'lat': 45.27076, 'lon': -66.05616}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut de Cardiologie de Montreal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '50406', 'city': 'Tartu', 'country': 'Estonia', 'facility': 'Tartu University Hospital', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'zip': '35033', 'city': 'Rennes', 'state': 'Brittany Region', 'country': 'France', 'facility': 'CHRU Hopital de Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '61231', 'city': 'Bad Nauheim', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Kerckhoff-Klinik gGmbH', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}, {'zip': '54292', 'city': 'Trier', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'Krankenhaus der Barmherzigen Brüder', 'geoPoint': {'lat': 49.75565, 'lon': 6.63935}}, {'zip': '04289', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Herzzentrum Leipzig GmbH', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '07747', 'city': 'Jena', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'Universitätsklinikum Jena', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '65760', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Deutsches Herzzentrum Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '21075', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Asklepios Klinik Harburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '20162', 'city': 'Milan', 'state': 'Lombardy', 'country': 'Italy', 'facility': "Ospedale Niguarda Ca'Granda", 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '51034', 'city': 'Florence', 'state': 'Tuscany', 'country': 'Italy', 'facility': 'Az. 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