Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 12:03 AM
Study NCT ID:
NCT03432494
Status:
TERMINATED
Last Update Posted:
2023-03-14
First Post:
2018-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ledermar@nhlbi.nih.gov', 'phone': '301.402.6769', 'title': 'Dr. Robert Lederman, Principal Investigator', 'organization': 'National Heart, Lung, and Blood Institute (NHLBI)'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The clinical trial was put suspended due to device needing to be redesign however funding never materialized to support the redesign, therefore, clinical trials was terminated early.'}}, 'adverseEventsModule': {'timeFrame': '12 months', 'description': 'Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).', 'eventGroups': [{'id': 'EG000', 'title': 'Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article', 'description': 'All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 1, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Hemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Aortic valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Mild AVR paravalvular leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Moderate PV aortic regurgitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Cardiac Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Conduction disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Right ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Edema limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Left femoral hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Right groin oozing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Small right groin hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Head laceration with fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Cardiac troponin I increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Haptoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Elevated BNP', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Elevated BUN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Elevated Haptoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Hypernatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Generalized muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'In-situ squamous cell carcinoma lesion on right dorsal forearm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Arterial thromboembolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Superficial thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Cardiac Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Mobitz (type) II atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Bronchial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'C. Difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Cardiac troponin I increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Chest wall pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Transient ischemic attacks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Shortness of Breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Arterial thromboembolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Labile blood pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Technical Success of Delivery of the Transcaval Closure Device (TCD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article', 'description': 'All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 minute following procedure discharge (Exit from the catheterization laboratory)', 'description': 'Number of participants with technical success of delivery of the transcaval closure device (TCD)\n\nAll of the following must be present for technical success:\n\n1. Alive\n2. Successful delivery of the TCD, and retrieval of the TCD delivery system\n3. Deployment and correct positioning of a single intended TCD. Repositioning and recapture of the device, if needed, is not classified as failure.\n4. No additional unplanned or emergency surgery or re-intervention related to the TCD or delivery system\n5. Adjunctive balloon aortic tamponade is permissible and consistent with technical success', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Closure Success of the Transcaval Closure Device (TCD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article', 'description': 'All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 minute following procedure discharge (Exit from the catheterization laboratory)', 'description': 'Number of Participants With Technical Closure Success of Delivery of the Transcaval Closure Device (TCD). This secondary endpoint is a composite of the primary endpoint and hemostasis of the transcaval aortic access site.\n\nAll of the following must be present for Closure Success:\n\n1. Alive\n2. Successful delivery of the TCD, and retrieval of the TCD delivery system\n3. Deployment and correct positioning of a single intended TCD. Repositioning and recapture of the device, if needed, is not classified as failure.\n4. No additional unplanned or emergency surgery or re-intervention related to the TCD or delivery system. Adjunctive balloon aortic tamponade is permissible and consistent with technical success\n5. Complete occlusion of the aortocaval fistula on the completion aortogram.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Device Success of the Transcaval Closure Device (TCD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article', 'description': 'All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).'}], 'classes': [{'title': '30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': '12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days and 12 Months', 'description': 'A key performance endpoint is the number of participants who experienced device success of the transcaval closure device (TCD).\n\nAll of the following must be present for device success:\n\n1. Alive or Death unrelated to transcaval access or TAVR\n2. Original intended TCD in place\n3. No additional surgical or interventional procedures related to access or the device after exit from the cath lab\n\nIntended performance of the TCD, including all of:\n\n1. Structural Performance: No migration, embolization, detachment, fracture, hemolysis, or endarteritis related to the TCD\n2. Hemodynamic performance: No abdominal aortic obstruction caused by the TCD implant\n3. Absence of para-device complications (large retroperitoneal hematoma, pseudoaneurysm, distal thromboembolism, or pulmonary thromboembolism)', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data will be analyzed using principles both of (1) intention-to-treat, defined as attempting or initiating transcaval crossing procedures, and (2) as-treated, defined as completing transcaval closure attempts.'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Experienced Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article', 'description': 'All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 Days', 'description': 'Number of participants that experienced safety endpoint of procedural success following transcaval closure device (TCD) at day 30.\n\nAll of the following must be present for procedural success:\n\n1. Device success\n2. No device-related Serious Adverse Events, defined as VARC-2 life-threatening bleeding, major vascular or cardiac complications related to the TCD requiring unplanned reintervention or surgery (such as covered stent implantation at the transcaval access site)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) analysis'}, {'type': 'SECONDARY', 'title': 'Number of Participants Requiring Covered Stent Implantation as a Normal Provisional Part of the Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article', 'description': 'All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During procedure, procedure may last from 2 to 4 hours', 'description': 'Number of participants requiring covered stent implantation as a normal provisional part of the procedure assessed during the procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Covered Stent Implantation at the Transcaval Closure Device Implantation Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article', 'description': 'All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During procedure, procedure may last from 2 to 4 hours', 'description': 'Number of participants with covered stent implantation at the transcaval closure device (TCD) implantation site', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Final Acute Aorto-caval Fistula Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article', 'description': 'All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).'}], 'classes': [{'categories': [{'title': 'Type 0', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Type 1', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Type 2', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Type 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 Days', 'description': 'Number of Participants final acute aorto-caval fistula score at procedure completion.\n\nScoring is defined as: Type 0=occlusion, Type 1=patent fistula, Type 2=cruci-form fistula pattern, Type 3=extravasation.\n\nA score of 0 is associated with complete occlusion at the transcaval closure device (TCD) site while a higher score is associated with incomplete occlusion at the TCD site.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention-to-treat (ITT) analysis'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Modified Valve Academic Research Consortium-2 Vascular Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article', 'description': 'All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).'}], 'classes': [{'title': 'Major : Unrelated to Transcaval Closure Device', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Major : At Least Possibly Related to Transcaval Closure Device', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Minor Unrelated to Transcaval Closure Device : Unrelated to Transcaval Closure Device', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Minor Unrelated to Transcaval Closure Device: At Least Possibly Related to Transcaval Closure Device', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Participants who experienced Minor or Major modified Valve Academic Research Consortium-2 (VARC-2) vascular complications.\n\nMajor is defined as: Aortic dissection or aortic rupture; Access site-related arterial or venous injury THAT RESULTS IN death, hemodynamic compromise, life-threatening, extensive; or major bleeding, visceral ischemia, neurological impairment; Distal embolization requiring surgery or resulting in amputation or irreversible end-organ damage; severe access site vascular complication Minor is defined as: Access site-related arterial or venous injury THAT DOES NOT RESULT IN death, hemodynamic compromise, life-threatening, extensive; or major bleeding, visceral ischemia, neurological impairment; Distal embolization treated with embolectomy and/or thrombectomy not resulting in amputation or irreversible end-organ damage; Any unplanned endovascular stenting or unplanned surgical intervention not meeting the criteria for a major vascular complication; Vascular repair', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention-to-treat (ITT) analysis'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Modified Valve Academic Research Consortium-2 Bleeding Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article', 'description': 'All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).'}], 'classes': [{'title': 'Life-threatening : Unrelated to Transcaval Closure Device', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Life-threatening : At least Possibly Related to Transcaval Closure Device', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Major : Unrelated to Transcaval Closure Device', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Major : At least Possibly Related to Transcaval Closure Device', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 Days', 'description': 'Number of Participants Who Experienced Major or Life-threatening Modified Valve Academic Research Consortium-2 (VARC-2) bleeding complications at 30 days\n\nMajor defined as: Corrected drop in the hemoglobin of \\>=3.0 g/dl AND does not meet criteria of life-threatening or extensive bleeding; Requiring transfusion of \\>=3 U of whole blood or packed RBCs AND does not meet criteria of life-threatening or extensive bleeding.\n\nLife-threatening defined as: Intracranial requiring surgery or intervention; Intraspinal requiring surgery or intervention; Intraocular requiring surgery or intervention; Pericardial requiring surgery or intervention; Intramuscular with compartment syndrome; Bleeding causing hypovolemic shock or hypotension or requiring significant doses of vasopressors or surgery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention-to-treat (ITT) analysis'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Major Adverse Cardiovascular Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article', 'description': 'All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).'}], 'classes': [{'title': 'Stroke : Unrelated to Transcaval Closure Device', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Stroke : At least possibly related to Transcaval Closure Device', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Myocardial Infraction : Unrelated to Transcaval Closure Device', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Myocardial Infraction : At least possibly related to Transcaval Closure Device', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Acute Kidney Injury (Stage II or III) : Unrelated to Transcaval Closure Device', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Acute Kidney Injury (Stage II or III) : At least possibly related to Transcaval Closure Device', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 30', 'description': 'Number of Participants Who Experienced Major Adverse Cardiovascular Events (MACE)\n\nMajor adverse cardiovascular events (MACE), defined as VARC-2 Early Safety composite: No mortality, stroke, life-threatening bleeding, acute kidney injury (AKI) stage 2+, major vascular complication, and valve-related complication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention-to-treat (ITT) analysis'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Closure Success of Delivery of the Transcaval Closure Device (TCD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article', 'description': 'All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).'}], 'classes': [{'title': '30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': '12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 Days and 12 Months', 'description': 'Number of Participants With Closure Success of Delivery of the Transcaval Closure Device (TCD).\n\nAll of the following must be present for Closure Success:\n\n1. Alive or Death unrelated to transcaval access or TAVR\n2. Successful delivery of the TCD, and retrieval of the TCD delivery system\n3. Deployment and correct positioning of a single intended TCD. Repositioning and recapture of the device, if needed, is not classified as failure.\n4. No additional unplanned or emergency surgery or re-intervention related to the TCD or delivery system. Adjunctive balloon aortic tamponade is permissible and consistent with technical success\n5. Complete occlusion of the aortocaval fistula on the completion aortogram.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data will be analyzed using principles both of (1) intention-to-treat, defined as attempting or initiating transcaval crossing procedures, and (2) as-treated, defined as completing transcaval closure attempts. For 12 months analysis, one participant died and one participant taken off study due to noncompliance.'}, {'type': 'SECONDARY', 'title': 'All-Cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article', 'description': 'All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).'}], 'classes': [{'title': 'Cardiovascular Deaths : Unrelated to Transcaval Closure Device', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Cardiovascular Deaths : At least possibly related to Transcaval Closure Device', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Non-Cardiovascular Deaths : Unrelated to Transcaval Closure Device', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Non-Cardiovascular Deaths : At least possibly related to Transcaval Closure Device', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 Days', 'description': 'All-cause mortality, as categorized by cardiovascular vs non-cardiovascular, peri- vs non-periprocedural, regardless of attribution to Transcaval Closure Device (TCD)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Aorto-caval Fistula Patency Assessed by Angiography and Arterial-phase Follow-up Computed Tomography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article', 'description': 'All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).'}], 'classes': [{'title': 'Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': '12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 30, 12 months', 'description': 'Number of participants with aorto-caval fistula patency at each timepoint, assessed combining completion angiography and arterial-phase follow-up Computed tomography (CT).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data will be analyzed using principles both of (1) intention-to-treat, defined as attempting or initiating transcaval crossing procedures, and (2) as-treated, defined as completing transcaval closure attempts. For month 12, one participant died and one participant taken off study due to noncompliance.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Acute Kidney Injury Stage 2 or 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article', 'description': 'All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).'}], 'classes': [{'title': 'Acute Kidney Injury, Stage II', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Acute Kidney Injury, Stage III', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 Days', 'description': 'Number of participants who experienced acute kidney injury (AKI) stage 2 or 3 using the Valve Academic Research Consortium (VARC).\n\nAKI using the VARC definition:\n\nStage 2: increase in serum creatinine to 200-300% (2.0-3.0 times increase compared to baseline) or increase of \\>0.3 mg/dl (\\>26.4 mmol/L) but \\<4.0 mg/dl (\\<354 mmol/L)\n\nStage 3: increase in serum creatinine to ≥300% (\\>3 times increase compared to baseline) or serum creatinine of ≥4.0 mg/dl (≥354 mmol/L), with acute increase of ≥0.5 mg/dl (44 mmol/L)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention-to-treat (ITT) analysis'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Are Free From Infection Related to the Transcaval Closure Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article', 'description': 'All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).'}], 'classes': [{'title': 'Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 30, 12 Months', 'description': 'Number of participants that experience freedom from infection related to the Transcaval Closure Device (TCD) at each time point', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) analysis. One participant died on post-procedure day 15 from respiratory failure attributed to exacerbation of previously unrecognized fibrotic pulmonary disease, adjudicated as noncardiovascular mortality and unrelated to transcaval access or TAVR. One participant at month 12 was taken off study due to non-compliance.'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Experience Thrombocytopenia and is Attributable to Residual Aorto-caval Fistula or the Transcaval Closure Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article', 'description': 'All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 Days', 'description': 'Number of participants that experience Thrombocytopenia as defined as \\< 50,000 and is attributable to residual aorto-caval fistula or the Transcaval Closure Device (TCD)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention-to-treat (ITT) analysis'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experience Hemolysis and is Attributable to Residual Aorto-caval Fistula or the Transcaval Closure Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article', 'description': 'All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 Days', 'description': 'Number of participants who experience hemolysis and is attributable to residual aorto-caval fistula or the Transcaval Closure Device (TCD)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention-to-treat (ITT) analysis'}, {'type': 'SECONDARY', 'title': 'Participant Cumulative Computed Tomography Analysis of Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article', 'description': 'All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).'}], 'classes': [{'title': 'Migration', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Erosion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Retroperitoneal hematoma', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Aortic pseudoaneurysm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Aortocaval tract pseudo-aneurysm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Intracaval mass or thrombus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Aortic dissection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 30', 'description': 'Participant cumulative Computed tomography (CT) analysis of device. As defined by: Device position; Device integrity; Aortocaval tract pseudo-aneurysm; Aortic pseudoaneurysm; Retroperitoneal hematoma grade (stranding {=absent and not evidence of overt bleeding;} small; moderate; larger); Intracaval mass or thrombus; Aortic dissection and inferred relatedness to TCD (adjacent to access port) or procedure (remote to access port)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention-to-treat (ITT) analysis'}, {'type': 'SECONDARY', 'title': 'Number of Participants Enrolled Greater Than 65 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article', 'description': 'All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Enrollment', 'description': 'Outcomes of subjects greater than 65 years (i.e. eligible for Medicare based on age), to determine generalizability to the Medicare population', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant is under 65 years of age and not included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article', 'description': 'All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article', 'description': 'All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ineligible for transfemoral access', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-12', 'size': 807981, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-11-07T09:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'The trial was kept open (via administrative hold) in anticipation of a device redesign and enrollment suspended, but funding never materialized to support the redesign.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'dispFirstSubmitDate': '2022-10-03', 'completionDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-15', 'studyFirstSubmitDate': '2018-02-13', 'resultsFirstSubmitDate': '2022-11-23', 'studyFirstSubmitQcDate': '2018-02-13', 'dispFirstPostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-15', 'studyFirstPostDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Technical Success of Delivery of the Transcaval Closure Device (TCD)', 'timeFrame': '1 minute following procedure discharge (Exit from the catheterization laboratory)', 'description': 'Number of participants with technical success of delivery of the transcaval closure device (TCD)\n\nAll of the following must be present for technical success:\n\n1. Alive\n2. Successful delivery of the TCD, and retrieval of the TCD delivery system\n3. Deployment and correct positioning of a single intended TCD. Repositioning and recapture of the device, if needed, is not classified as failure.\n4. No additional unplanned or emergency surgery or re-intervention related to the TCD or delivery system\n5. Adjunctive balloon aortic tamponade is permissible and consistent with technical success'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Closure Success of the Transcaval Closure Device (TCD)', 'timeFrame': '1 minute following procedure discharge (Exit from the catheterization laboratory)', 'description': 'Number of Participants With Technical Closure Success of Delivery of the Transcaval Closure Device (TCD). This secondary endpoint is a composite of the primary endpoint and hemostasis of the transcaval aortic access site.\n\nAll of the following must be present for Closure Success:\n\n1. Alive\n2. Successful delivery of the TCD, and retrieval of the TCD delivery system\n3. Deployment and correct positioning of a single intended TCD. Repositioning and recapture of the device, if needed, is not classified as failure.\n4. No additional unplanned or emergency surgery or re-intervention related to the TCD or delivery system. Adjunctive balloon aortic tamponade is permissible and consistent with technical success\n5. Complete occlusion of the aortocaval fistula on the completion aortogram.'}, {'measure': 'Number of Participants Who Experienced Device Success of the Transcaval Closure Device (TCD)', 'timeFrame': '30 days and 12 Months', 'description': 'A key performance endpoint is the number of participants who experienced device success of the transcaval closure device (TCD).\n\nAll of the following must be present for device success:\n\n1. Alive or Death unrelated to transcaval access or TAVR\n2. Original intended TCD in place\n3. No additional surgical or interventional procedures related to access or the device after exit from the cath lab\n\nIntended performance of the TCD, including all of:\n\n1. Structural Performance: No migration, embolization, detachment, fracture, hemolysis, or endarteritis related to the TCD\n2. Hemodynamic performance: No abdominal aortic obstruction caused by the TCD implant\n3. Absence of para-device complications (large retroperitoneal hematoma, pseudoaneurysm, distal thromboembolism, or pulmonary thromboembolism)'}, {'measure': 'Number of Participants That Experienced Procedural Success', 'timeFrame': '30 Days', 'description': 'Number of participants that experienced safety endpoint of procedural success following transcaval closure device (TCD) at day 30.\n\nAll of the following must be present for procedural success:\n\n1. Device success\n2. No device-related Serious Adverse Events, defined as VARC-2 life-threatening bleeding, major vascular or cardiac complications related to the TCD requiring unplanned reintervention or surgery (such as covered stent implantation at the transcaval access site)'}, {'measure': 'Number of Participants Requiring Covered Stent Implantation as a Normal Provisional Part of the Procedure', 'timeFrame': 'During procedure, procedure may last from 2 to 4 hours', 'description': 'Number of participants requiring covered stent implantation as a normal provisional part of the procedure assessed during the procedure.'}, {'measure': 'Number of Participants With Covered Stent Implantation at the Transcaval Closure Device Implantation Site', 'timeFrame': 'During procedure, procedure may last from 2 to 4 hours', 'description': 'Number of participants with covered stent implantation at the transcaval closure device (TCD) implantation site'}, {'measure': 'Number of Participants Final Acute Aorto-caval Fistula Score', 'timeFrame': '30 Days', 'description': 'Number of Participants final acute aorto-caval fistula score at procedure completion.\n\nScoring is defined as: Type 0=occlusion, Type 1=patent fistula, Type 2=cruci-form fistula pattern, Type 3=extravasation.\n\nA score of 0 is associated with complete occlusion at the transcaval closure device (TCD) site while a higher score is associated with incomplete occlusion at the TCD site.'}, {'measure': 'Number of Participants Who Experienced Modified Valve Academic Research Consortium-2 Vascular Complications', 'timeFrame': '30 days', 'description': 'Participants who experienced Minor or Major modified Valve Academic Research Consortium-2 (VARC-2) vascular complications.\n\nMajor is defined as: Aortic dissection or aortic rupture; Access site-related arterial or venous injury THAT RESULTS IN death, hemodynamic compromise, life-threatening, extensive; or major bleeding, visceral ischemia, neurological impairment; Distal embolization requiring surgery or resulting in amputation or irreversible end-organ damage; severe access site vascular complication Minor is defined as: Access site-related arterial or venous injury THAT DOES NOT RESULT IN death, hemodynamic compromise, life-threatening, extensive; or major bleeding, visceral ischemia, neurological impairment; Distal embolization treated with embolectomy and/or thrombectomy not resulting in amputation or irreversible end-organ damage; Any unplanned endovascular stenting or unplanned surgical intervention not meeting the criteria for a major vascular complication; Vascular repair'}, {'measure': 'Number of Participants Who Experienced Modified Valve Academic Research Consortium-2 Bleeding Complications', 'timeFrame': '30 Days', 'description': 'Number of Participants Who Experienced Major or Life-threatening Modified Valve Academic Research Consortium-2 (VARC-2) bleeding complications at 30 days\n\nMajor defined as: Corrected drop in the hemoglobin of \\>=3.0 g/dl AND does not meet criteria of life-threatening or extensive bleeding; Requiring transfusion of \\>=3 U of whole blood or packed RBCs AND does not meet criteria of life-threatening or extensive bleeding.\n\nLife-threatening defined as: Intracranial requiring surgery or intervention; Intraspinal requiring surgery or intervention; Intraocular requiring surgery or intervention; Pericardial requiring surgery or intervention; Intramuscular with compartment syndrome; Bleeding causing hypovolemic shock or hypotension or requiring significant doses of vasopressors or surgery'}, {'measure': 'Number of Participants Who Experienced Major Adverse Cardiovascular Events', 'timeFrame': 'Day 30', 'description': 'Number of Participants Who Experienced Major Adverse Cardiovascular Events (MACE)\n\nMajor adverse cardiovascular events (MACE), defined as VARC-2 Early Safety composite: No mortality, stroke, life-threatening bleeding, acute kidney injury (AKI) stage 2+, major vascular complication, and valve-related complication.'}, {'measure': 'Number of Participants With Closure Success of Delivery of the Transcaval Closure Device (TCD)', 'timeFrame': '30 Days and 12 Months', 'description': 'Number of Participants With Closure Success of Delivery of the Transcaval Closure Device (TCD).\n\nAll of the following must be present for Closure Success:\n\n1. Alive or Death unrelated to transcaval access or TAVR\n2. Successful delivery of the TCD, and retrieval of the TCD delivery system\n3. Deployment and correct positioning of a single intended TCD. Repositioning and recapture of the device, if needed, is not classified as failure.\n4. No additional unplanned or emergency surgery or re-intervention related to the TCD or delivery system. Adjunctive balloon aortic tamponade is permissible and consistent with technical success\n5. Complete occlusion of the aortocaval fistula on the completion aortogram.'}, {'measure': 'All-Cause Mortality', 'timeFrame': '30 Days', 'description': 'All-cause mortality, as categorized by cardiovascular vs non-cardiovascular, peri- vs non-periprocedural, regardless of attribution to Transcaval Closure Device (TCD)'}, {'measure': 'Number of Participants With Aorto-caval Fistula Patency Assessed by Angiography and Arterial-phase Follow-up Computed Tomography', 'timeFrame': 'Day 30, 12 months', 'description': 'Number of participants with aorto-caval fistula patency at each timepoint, assessed combining completion angiography and arterial-phase follow-up Computed tomography (CT).'}, {'measure': 'Number of Participants Who Experienced Acute Kidney Injury Stage 2 or 3', 'timeFrame': '30 Days', 'description': 'Number of participants who experienced acute kidney injury (AKI) stage 2 or 3 using the Valve Academic Research Consortium (VARC).\n\nAKI using the VARC definition:\n\nStage 2: increase in serum creatinine to 200-300% (2.0-3.0 times increase compared to baseline) or increase of \\>0.3 mg/dl (\\>26.4 mmol/L) but \\<4.0 mg/dl (\\<354 mmol/L)\n\nStage 3: increase in serum creatinine to ≥300% (\\>3 times increase compared to baseline) or serum creatinine of ≥4.0 mg/dl (≥354 mmol/L), with acute increase of ≥0.5 mg/dl (44 mmol/L)'}, {'measure': 'Number of Participants That Are Free From Infection Related to the Transcaval Closure Device', 'timeFrame': 'Day 30, 12 Months', 'description': 'Number of participants that experience freedom from infection related to the Transcaval Closure Device (TCD) at each time point'}, {'measure': 'Number of Participants That Experience Thrombocytopenia and is Attributable to Residual Aorto-caval Fistula or the Transcaval Closure Device', 'timeFrame': '30 Days', 'description': 'Number of participants that experience Thrombocytopenia as defined as \\< 50,000 and is attributable to residual aorto-caval fistula or the Transcaval Closure Device (TCD)'}, {'measure': 'Number of Participants Who Experience Hemolysis and is Attributable to Residual Aorto-caval Fistula or the Transcaval Closure Device', 'timeFrame': '30 Days', 'description': 'Number of participants who experience hemolysis and is attributable to residual aorto-caval fistula or the Transcaval Closure Device (TCD)'}, {'measure': 'Participant Cumulative Computed Tomography Analysis of Device', 'timeFrame': 'Day 30', 'description': 'Participant cumulative Computed tomography (CT) analysis of device. As defined by: Device position; Device integrity; Aortocaval tract pseudo-aneurysm; Aortic pseudoaneurysm; Retroperitoneal hematoma grade (stranding {=absent and not evidence of overt bleeding;} small; moderate; larger); Intracaval mass or thrombus; Aortic dissection and inferred relatedness to TCD (adjacent to access port) or procedure (remote to access port)'}, {'measure': 'Number of Participants Enrolled Greater Than 65 Years', 'timeFrame': 'Enrollment', 'description': 'Outcomes of subjects greater than 65 years (i.e. eligible for Medicare based on age), to determine generalizability to the Medicare population'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Transcatheter', 'Transcaval', 'Bioprosthesis', 'Closure Device', 'Aortic Stenosis'], 'conditions': ['Aortic Stenosis']}, 'referencesModule': {'references': [{'pmid': '31629746', 'type': 'DERIVED', 'citation': 'Rogers T, Greenbaum AB, Babaliaros VC, Stine AM, Khan JM, Schenke WH, Eng MH, Paone G, Leshnower BG, Satler LF, Waksman R, Chen MY, Lederman RJ. Dedicated Closure Device for Transcaval Access Closure: From Concept to First-in-Human Testing. JACC Cardiovasc Interv. 2019 Nov 11;12(21):2198-2206. doi: 10.1016/j.jcin.2019.05.053. Epub 2019 Oct 16.'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nTranscatheter aortic valve replacement (TAVR) is a non-surgical alternative to standard surgical aortic valve replacement. Not all patients are eligible for TAVR using standard access through the artery in the groin, because the artery is too small or too diseased. In this study, TAVR is performed using a new technique called transcaval access. The catheter is placed in the artery deep in the body by crossing through the wall of a deep vein. The connection between that vein and the aorta is closed with a new metallic device they are testing. This is called a transcaval closure device (TCD).\n\nObjective:\n\nTo test the safety and early feasibility of closure of transcaval aortic access sites using the TCD after TAVR.\n\nEligibility:\n\nAdults ages 21 and older undergoing TAVR for whom the procedure cannot be performed safely by the standard artery approach\n\nDesign:\n\nParticipants will be assessed by heart experts including cardiologists and surgeons.\n\nParticipants will have TAVR by the transcaval approach. A small catheter will be passed between the largest vein in the body and the nearby largest artery (aorta), inside the abdomen. Through this catheter, the TAVR will be implanted in the usual way.\n\nAfter, doctors will implant the TCD by catheter to close the hole made in the aorta.\n\nParticipants will be X-rayed. A dye will be injected to view the TCD device.\n\nParticipants will get standard TAVR care afterwards. They will have physical exams, blood tests, and scans.\n\nParticipants will have a follow-up scan within 1 month and after 12 months.\n\nParticipants will have follow-up visits and phone calls 6 and 12 months after the procedure.', 'detailedDescription': 'Transcaval access to the abdominal aorta from the neighboring inferior vena cava (IVC) enables transcatheter aortic valve replacement (TAVR) in patients not eligible for femoral artery access. Currently the procedure is performed using devices, off-label, designed and marketed to close holes inside the heart and great vessels, manufactured by Abbott St Jude (Amplatzer Duct Occluder and Amplatzer Muscular VSD Occluder). Because these Amplatzer occluders are not designed to close transcaval access sites, they may not completely prevent bleeding.\n\nThis is an early feasibility study (EFS) evaluation of a purpose-built closure device for transcaval access. The device, the Transcaval closure device (TCD) will be evaluated for safety and performance to close transcaval access sites in patients ineligible for femoral artery access for TAVR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n* Consents to participate in this study and all related clinical follow-up procedures\n* Adults age greater than or equal to 21 years\n* Undergoing transcatheter aortic valve replacement (TAVR) based on the clinical assessment of the multidisciplinary heart team\n* Ineligible for femoral artery access for the selected transcatheter heart valve (THV) according to the THV manufacturer instructions for use. (Note Corevalve Evolut R: greater than or equal to 5mm; Evolut PRO 23, 26, 29 mm valves and Evolut R 34 mm: greater than or equal to 5.5 mm; Edwards Sapien 3, 23-26mm: 5.5 mm; Edwards Sapien 3, 29mm: 6.0mm; Anatomic ineligibility also considers patient-specific pattern of iliofemoral calcium and tortuosity.)\n* Eligible for transcaval access based on Core lab analysis of the baseline abdomen/pelvis CT indicating a calcium-free target window on the abdominal aorta; a target greater than or equal to 15mm from the lowest main renal artery or aorto-iliac bifurcation; no important interposed structures; a projected intravascular centerline distance from the lower femoral head to the target at least 5cm less than the intended THV introducer sheath; patient celiac or superior mesenteric artery\n* Aorta diameter greater than or equal to 11mm at the target crossing site\n* Concordance of the study eligibility committee\n\nEXCLUSION CRITERIA:\n\n* High risk features on baseline CT including porcelain aorta (confluent calcification); pedunculated aortic atheroma; or leftward aortic angel greater than or equal to 20 degrees with regard to vertical.\n* Renal dysfunction limiting follow-up contrast-enhanced CR (estimated glomerular filtration rate, eGFR less than 30mL/min/1.73m\\^2 if not already on renal replacement therapy)\n* Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures'}, 'identificationModule': {'nctId': 'NCT03432494', 'briefTitle': 'Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Early Feasibility Evaluation of Transmural Systems Transcaval Closure Device (TCD) for Transcaval Access Ports During Transcatheter Aortic Valve Replacement (TAVR)', 'orgStudyIdInfo': {'id': '999918045'}, 'secondaryIdInfos': [{'id': '18-H-N045'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcaval access and closure with the transcaval closure device (TCD) test article.', 'description': 'All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).', 'interventionNames': ['Device: Transcaval closure device (TCD)']}], 'interventions': [{'name': 'Transcaval closure device (TCD)', 'type': 'DEVICE', 'description': 'Transcaval access and closure using the Transmural Transcaval Closure Device (TCD) at the time of medically-necessary transcatheter aortic valve replacement (TAVR).', 'armGroupLabels': ['Transcaval access and closure with the transcaval closure device (TCD) test article.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'overallOfficials': [{'name': 'Robert J Lederman, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Heart, Lung, and Blood Institute (NHLBI)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The authors are willing to share de-identified subject data upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}