Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT01383720
Status:
COMPLETED
Last Update Posted:
2017-06-20
First Post:
2011-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve SystEm
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'C562942', 'term': 'Aortic Valve, Calcification of'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}], 'ancestors': [{'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': {'phone': '408-370-1550', 'title': 'Director of Clinical Trials, Valves', 'organization': 'Boston Scientific Corporation'}, 'certainAgreement': {'otherDetails': 'The Principal Investigator (PI) shall have the right to publish the results, provided that before publishing, the PI shall submit copies of any proposed publication or presentation to the Sponsor for review at least 45 days in advance of submission for publication or presentation to a publisher or other third party. Sponsor reserves the right to delete any confidential information or other proprietary information of Sponsor from the proposed publication or presentation.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'After 1 year index procedure', 'eventGroups': [{'id': 'EG000', 'title': 'Lotus Valve System', 'description': 'Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis', 'otherNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Secretion discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Arterial injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Petechiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Peripheral artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'seriousEvents': [{'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotus Valve System', 'description': 'Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Discharge or 7 days post-procedure, whichever comes first', 'description': 'Clinical procedural success defined as successful implantation of a Lotus Valve System (Device Success) without in-hospital Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) through discharge or 7 days post-procedure, whichever comes first.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis'}, {'type': 'SECONDARY', 'title': 'Device Performance Endpoint-Repositioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotus Valve System', 'description': 'Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'procedure', 'description': 'Successful repositioning of the Lotus Valve System if repositioning is attempted', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in whom repositioning of the Lotus Valve was attempted'}, {'type': 'SECONDARY', 'title': 'Device Performance Endpoint-Valve Retrieval, if Attempted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotus Valve System', 'description': 'Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'There were no attempts made to retrieve the valve.', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'procedure', 'description': 'Successful retrieval of the Lotus Valve System if retrieval is attempted', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Central Aortic Regurgitation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotus Valve System', 'description': 'Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Trivial', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Moderate or Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Discharge or 7 days post-procedure, whichever comes first', 'description': 'As determined by echocardiography', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Paravalvular Aortic Regurgitation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotus Valve System', 'description': 'Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Trivial', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Moderate or Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Discharge or 7 days post-procedure, whichever comes first', 'description': 'As determined by echocardiography', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Successful Access, Device Delivery, Deployment and Positioning and Retrieval of Delivery System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotus Valve System', 'description': 'Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Procedure', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Intended Performance of the Lotus Valve', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotus Valve System', 'description': 'Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At time of discharge or 7 days post procedure', 'description': 'Aortic valve area \\>1.0 cm2 plus either a mean aortic valve gradient \\<20 mmHg or peak velocity \\<3m/sec, without moderate or severe prosthetic valve aortic regurgitation', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Single Valve Implanted in the Proper Anatomical Location', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotus Valve System', 'description': 'Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'procedure', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'No Major Adverse Cardiovascular and Cerebrovascular Events Through Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotus Valve System', 'description': 'Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Discharge or 7 days post-procedure, whichever comes first', 'description': 'Major adverse cardiovascular or cerebrovascular events include all-cause mortality, periprocedural myocardial infarction ≤72 hours, major stroke, urgent/emergent conversion to surgery or repeat procedure for valve-related dysfunction', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Aortic Valve Gradient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotus Valve System', 'description': 'Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis'}], 'classes': [{'categories': [{'measurements': [{'value': '13.7', 'spread': '3.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Discharge or 7 days post-procedure, whichever comes first', 'description': 'As determined by echocardiography', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Aortic Valve Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotus Valve System', 'description': 'Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis'}], 'classes': [{'categories': [{'measurements': [{'value': '1.53', 'spread': '0.18', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Discharge or 7 days post-procedure, whichever comes first', 'description': 'As determined by echocardiography', 'unitOfMeasure': 'cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotus Valve System', 'description': 'Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Discharge or 7 days post-procedure, whichever comes first', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Peri-procedural Myocardial Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotus Valve System', 'description': 'Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '72 hours', 'description': 'Peri-Procedural Myocardial Infarction (≤72 hours after the index procedure)\n\n* New ischemic symptoms (e.g., chest pain or shortness of breath), or new ischemic signs (e.g. ventricular arrhythmias, new or worsening heart failure, new ST-segment changes, hemodynamic instability, or imaging evidence of new loss of viable myocardium or new wall motion abnormality), AND\n* Elevated cardiac biomarkers (preferably creatine kinase-myoglobin band) within 72 h after the index procedure, consisting of two or more post-procedure samples that are \\> 0.6 to 8 h apart with a 20% increase in the second sample and a peak value exceeding 10X the 99th percentile upper reference limit (URL), or a peak value exceeding 5X the 99th percentile URL with new pathological Q waves in at least 2 contiguous leads', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Major Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotus Valve System', 'description': 'Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Discharge or 7 days post-procedure, whichever comes first', 'description': 'Confirmed with a Modified Rankin score \\>/= 2 at 30 and 90 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Urgent/Emergent Conversion to Surgery or Repeat Procedure for Valve-related Dysfunction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotus Valve System', 'description': 'Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Discharge or 7 days post-procedure, whichever comes first', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Major Vascular Complication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotus Valve System', 'description': 'Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Discharge or 7 days post-procedure, whichever comes first', 'description': '* Any thoracic aortic dissection\n* Access site or access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, hematoma, irreversible nerve injury, or compartment syndrome) leading to either death, need for significant blood transfusions (≥4 units), unplanned percutaneous or surgical intervention, or irreversible end-organ damage (e.g. hypogastric artery occlusion causing visceral ischemia or spinal artery injury causing neurologic impairment)\n* Distal embolization (non-cerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'New Conduction Disturbances or Arrhythmias Requiring Permanent Pacemaker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotus Valve System', 'description': 'Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Discharge or 7 days post-procedure, whichever comes first', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotus Valve System', 'description': 'Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis'}], 'classes': [{'title': 'Life-threatening or disabling', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Major', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Discharge or 7 days post-procedure, whichever comes first', 'description': 'Life-threatening or Disabling Bleeding\n\n* Fatal bleeding OR\n* Bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome OR\n* Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery OR\n* Overt source of bleeding with drop in hemoglobin of ≥5 g/dL or whole blood or packed red blood cells (RBC) transfusion ≥4 units\n\nMajor Bleeding\n\n* Overt bleeding either associated with a drop in the hemoglobin level of at least 3.0g/dL or requiring transfusion of 2 or 3 units of whole blood/RBC AND\n* Does not meet criteria of life-threatening or disabling bleeding', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Acute Kidney Injury - Stage 2 or 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotus Valve System', 'description': 'Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Discharge or 7 days post-procedure, whichever comes first', 'description': 'Stage 2: Increase in serum creatinine to 200-300% (2.0-3.0 times increase compared with baseline).\n\nStage 3: Increase in serum creatinine to ≥ 300% (\\> 3 times increase compared with baseline) or serum creatinine of ≥ 4.0 mg/d (≥ 354 μmol/L) with an acute increase of at least 0.5 mg/dl (44 μmol/L). Subjects receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lotus Valve System', 'description': 'Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Primary Endpoint (Discharge/7 Days)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Study is continuing to 5 years. All patients are still in the study.', 'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were identified by their physicians as meeting the study inclusion/exclusion criteria.', 'preAssignmentDetails': 'Screening materials from patients identified by the investigators as having met the inclusion and exclusion criteria were reviewed by a Case Review Committee to assess and confirm eligibility.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lotus Valve System', 'description': 'Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '83.0', 'spread': '3.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'General Medical History', 'classes': [{'title': 'Diabetes mellitus (current)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Hyperlipidemia (medically treated)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Hypertension (medically treated)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'History of peripheral vascular disease', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Dialysis dependent renal failure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Chronic obstructive pulmonary disease', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'The same participant may be included in more than one category therefore the number of participants for this baseline measure does not equal the total number of participants in the group.', 'unitOfMeasure': 'participants'}, {'title': 'Cardiac History', 'classes': [{'title': 'Coronary artery disease', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Previous percutaneous coronary intervention', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Previous coronary artery bypass graft surgery', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'History of atrial fibrillation', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'The same participant may be included in more than one category therefore the number of participants for this baseline measure does not equal the total number of participants in the group.', 'unitOfMeasure': 'participants'}, {'title': 'New York Heart Association Class', 'classes': [{'title': 'Class I', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Class II', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Class III', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Class IV', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': "New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.\n\nClass I (Mild): No limitation of physical activity. Class II (Mild): Slight limitation of physical activity. Class III (Moderate): Marked limitation of physical activity. Class IV (Severe): Unable to carry out any physical activity without discomfort.\n\nSymptomatic aortic valve stenosis is related to NYHA Functional Class ≥ II.", 'unitOfMeasure': 'participants'}, {'title': 'Modified Rankin Scale', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': '3 or higher', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Higher score equals a worse condition with zero meaning no symptoms, 2 meaning slight disability and 6 meaning death.', 'unitOfMeasure': 'participants'}, {'title': 'Neurological History', 'classes': [{'title': 'Transient Ischemic Attack', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Cerebrovascular Accident', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'A patient may or may not belong to a category or may belong to more than one category. Therefore the sum may not equal the overall number of patients in the study.', 'unitOfMeasure': 'participants'}, {'title': 'Aortic valve area (effective orifice area)', 'classes': [{'categories': [{'measurements': [{'value': '0.68', 'spread': '0.19', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mean Aortic Valve Gradient', 'classes': [{'categories': [{'measurements': [{'value': '53.9', 'spread': '20.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Left Ventricular Ejection Fraction', 'classes': [{'categories': [{'measurements': [{'value': '62.3', 'spread': '7.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'This measure represents the percent of Left Ventricular Ejection Fraction.', 'unitOfMeasure': 'percent of LVEF', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Aortic regurgitation (moderate or severe)', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'A patient may or may not belong to a category or may belong to more than one category. Therefore the sum may not equal the overall number of patients in the study.', 'unitOfMeasure': 'participants'}, {'title': 'Mitral Regurgitation (moderate or severe)', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'A patient may or may not belong to a category or may belong to more than one category. Therefore the sum may not equal the overall number of patients in the study.', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '27.6', 'spread': '6.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Serum Albumin', 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '0.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '5-Meter Gait Speed', 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'spread': '4.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'seconds', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Maximum Grip Strength Average', 'classes': [{'categories': [{'measurements': [{'value': '15.3', 'spread': '5.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Katz Index', 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'spread': '0.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "Katz Index of Independence in Activities of Daily Living (ADL) is an instrument to assess functional status as a measurement of the client's ability to perform activities of daily living independently.\n\nThe Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mini-Cognitive Assessment for Dementia', 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '1.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Mini-Cognitive Assessment for Dementia scores range from 5 (normal cognition) to 0 (impaired cognition).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Charlson Comorbidity Index Score', 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '1.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "Charlson Comorbidity Index contains 19 categories of comorbidity and assigns a weighted value to each subject's comorbidity based on the risk of 1-year mortality.\n\nA score of 0 reflects no comorbidities and 19 reveals severe comorbidities.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Society of Thoracic Surgeons (STS) Score', 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'spread': '2.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "The Society of Thoracic Surgeons' risk models predict the risk of operative mortality and morbidity after adult cardiac surgery on the basis of patient demographic and clinical variables. The patient is considered at high risk for surgical aortic valve replacement with an STS score ≥8% or a EuroSCORE ≥20%, or documented multidisciplinary heart team agreement that the patient is at high risk for surgery due to frailty and/or coexisting comorbidities. For example, an STS score of 10% means predicted operative mortality or serious, irreversible morbidity risk of 10% at 30 days.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'EuroScore', 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'spread': '4.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'European System for Cardiac Operative Risk Evaluation. EuroSCORE is a method of calculating predicted operative mortality for patients undergoing cardiac surgery.\n\nThe patient is considered at high risk for surgical aortic valve replacement with an STS score ≥8% or a EuroSCORE ≥20%, or documented multidisciplinary heart team agreement that the patient is at high risk for surgery due to frailty and/or coexisting comorbidities. EuroScore II is a risk model that calculates the risk of death after a heart operation through 30 days.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-23', 'studyFirstSubmitDate': '2011-06-27', 'resultsFirstSubmitDate': '2013-04-16', 'studyFirstSubmitQcDate': '2011-06-27', 'lastUpdatePostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-05-01', 'studyFirstPostDateStruct': {'date': '2011-06-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Successful Access, Device Delivery, Deployment and Positioning and Retrieval of Delivery System', 'timeFrame': 'Procedure'}, {'measure': 'Intended Performance of the Lotus Valve', 'timeFrame': 'At time of discharge or 7 days post procedure', 'description': 'Aortic valve area \\>1.0 cm2 plus either a mean aortic valve gradient \\<20 mmHg or peak velocity \\<3m/sec, without moderate or severe prosthetic valve aortic regurgitation'}, {'measure': 'Single Valve Implanted in the Proper Anatomical Location', 'timeFrame': 'procedure'}, {'measure': 'No Major Adverse Cardiovascular and Cerebrovascular Events Through Discharge', 'timeFrame': 'Discharge or 7 days post-procedure, whichever comes first', 'description': 'Major adverse cardiovascular or cerebrovascular events include all-cause mortality, periprocedural myocardial infarction ≤72 hours, major stroke, urgent/emergent conversion to surgery or repeat procedure for valve-related dysfunction'}, {'measure': 'Mean Aortic Valve Gradient', 'timeFrame': 'Discharge or 7 days post-procedure, whichever comes first', 'description': 'As determined by echocardiography'}, {'measure': 'Aortic Valve Area', 'timeFrame': 'Discharge or 7 days post-procedure, whichever comes first', 'description': 'As determined by echocardiography'}, {'measure': 'Death', 'timeFrame': 'Discharge or 7 days post-procedure, whichever comes first'}, {'measure': 'Peri-procedural Myocardial Infarction', 'timeFrame': '72 hours', 'description': 'Peri-Procedural Myocardial Infarction (≤72 hours after the index procedure)\n\n* New ischemic symptoms (e.g., chest pain or shortness of breath), or new ischemic signs (e.g. ventricular arrhythmias, new or worsening heart failure, new ST-segment changes, hemodynamic instability, or imaging evidence of new loss of viable myocardium or new wall motion abnormality), AND\n* Elevated cardiac biomarkers (preferably creatine kinase-myoglobin band) within 72 h after the index procedure, consisting of two or more post-procedure samples that are \\> 0.6 to 8 h apart with a 20% increase in the second sample and a peak value exceeding 10X the 99th percentile upper reference limit (URL), or a peak value exceeding 5X the 99th percentile URL with new pathological Q waves in at least 2 contiguous leads'}, {'measure': 'Major Stroke', 'timeFrame': 'Discharge or 7 days post-procedure, whichever comes first', 'description': 'Confirmed with a Modified Rankin score \\>/= 2 at 30 and 90 days'}, {'measure': 'Urgent/Emergent Conversion to Surgery or Repeat Procedure for Valve-related Dysfunction', 'timeFrame': 'Discharge or 7 days post-procedure, whichever comes first'}, {'measure': 'Major Vascular Complication', 'timeFrame': 'Discharge or 7 days post-procedure, whichever comes first', 'description': '* Any thoracic aortic dissection\n* Access site or access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, hematoma, irreversible nerve injury, or compartment syndrome) leading to either death, need for significant blood transfusions (≥4 units), unplanned percutaneous or surgical intervention, or irreversible end-organ damage (e.g. hypogastric artery occlusion causing visceral ischemia or spinal artery injury causing neurologic impairment)\n* Distal embolization (non-cerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage'}, {'measure': 'New Conduction Disturbances or Arrhythmias Requiring Permanent Pacemaker', 'timeFrame': 'Discharge or 7 days post-procedure, whichever comes first'}, {'measure': 'Bleeding', 'timeFrame': 'Discharge or 7 days post-procedure, whichever comes first', 'description': 'Life-threatening or Disabling Bleeding\n\n* Fatal bleeding OR\n* Bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome OR\n* Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery OR\n* Overt source of bleeding with drop in hemoglobin of ≥5 g/dL or whole blood or packed red blood cells (RBC) transfusion ≥4 units\n\nMajor Bleeding\n\n* Overt bleeding either associated with a drop in the hemoglobin level of at least 3.0g/dL or requiring transfusion of 2 or 3 units of whole blood/RBC AND\n* Does not meet criteria of life-threatening or disabling bleeding'}, {'measure': 'Acute Kidney Injury - Stage 2 or 3', 'timeFrame': 'Discharge or 7 days post-procedure, whichever comes first', 'description': 'Stage 2: Increase in serum creatinine to 200-300% (2.0-3.0 times increase compared with baseline).\n\nStage 3: Increase in serum creatinine to ≥ 300% (\\> 3 times increase compared with baseline) or serum creatinine of ≥ 4.0 mg/d (≥ 354 μmol/L) with an acute increase of at least 0.5 mg/dl (44 μmol/L). Subjects receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria.'}], 'primaryOutcomes': [{'measure': 'Clinical Procedural Success', 'timeFrame': 'Discharge or 7 days post-procedure, whichever comes first', 'description': 'Clinical procedural success defined as successful implantation of a Lotus Valve System (Device Success) without in-hospital Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) through discharge or 7 days post-procedure, whichever comes first.'}], 'secondaryOutcomes': [{'measure': 'Device Performance Endpoint-Repositioning', 'timeFrame': 'procedure', 'description': 'Successful repositioning of the Lotus Valve System if repositioning is attempted'}, {'measure': 'Device Performance Endpoint-Valve Retrieval, if Attempted', 'timeFrame': 'procedure', 'description': 'Successful retrieval of the Lotus Valve System if retrieval is attempted'}, {'measure': 'Central Aortic Regurgitation', 'timeFrame': 'Discharge or 7 days post-procedure, whichever comes first', 'description': 'As determined by echocardiography'}, {'measure': 'Paravalvular Aortic Regurgitation', 'timeFrame': 'Discharge or 7 days post-procedure, whichever comes first', 'description': 'As determined by echocardiography'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Aortic Valve Stenosis', 'Transcatheter Aortic Valve Replacement'], 'conditions': ['Aortic Valve Stenosis', 'Aortic Valve Calcification', 'Aortic Valve Disease']}, 'descriptionModule': {'briefSummary': 'This is a prospective, single-arm feasibility study designed to assess the acute safety and performance of the Lotus Valve System for transcatheter aortic valve replacement in symptomatic patients with calcified aortic valve stenosis and who are at high risk for surgical intervention.', 'detailedDescription': 'The incidence of aortic stenosis is increasing due to the aging of the world-wide population and the lack of drug therapies to prevent, halt, or effectively slow the stenotic process. Transcatheter aortic valve replacement has become a viable alternative for treatment of severe symptomatic aortic stenosis in selected patients who are unsuitable candidates for surgical valve replacement. The Lotus Valve System is designed to enable precise placement and minimize or eliminate the paravalvular regurgitation and associated adverse events seen with earlier generation devices. The REPRISE I study assesses acute safety and performance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient must be at least 70 years of age or older, and meets all of the criteria below.\n2. Patient has documented calcified native aortic valve stenosis, defined with an initial aortic valve area (AVA) of \\<1.0 cm2 (or AVA index of \\<0.6 cm2/m2), and a mean pressure gradient \\>40 mmHg or a jet velocity \\>4 m/s, as measured by echocardiography.\n3. The patient is considered at high risk for surgical aortic valve replacement with an STS (Society of Thoracic Surgeons) score ≥8% or a EuroSCORE ≥20%, or documented multidisciplinary heart team agreement that the patient is at high risk for surgery due to frailty and/or coexisting comorbidities.\n4. Symptomatic aortic valve stenosis with New York Heart Association (NYHA) Functional Class ≥ II.\n5. Patient has a documented aortic annulus size between 19 and 22 mm (able to accommodate the 23 mm Lotus™ Valve). Pre-procedure measurement by transthoracic echocardiography (TTE) is required. Other imaging modalities (e.g., transesophageal echocardiography (TEE), CT scan) can be used in an adjunctive manner.\n6. Patient (or legal representative) understands the trial requirements and the treatment procedures, and provides written informed consent.\n7. Patient agrees and is capable of returning to the study hospital for all required scheduled follow up visits.\n\nExclusion Criteria:\n\n1. Patient has a congenital unicuspid or bicuspid aortic valve.\n2. Patient with an acute myocardial infarction (MI) within 30 days of the index procedure (defined as Q wave MI, or non-Q wave MI with total creatine kinase (CK) elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin level elevation (WHO definition)).\n3. Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months, or has any permanent neurologic defect prior to study enrollment.\n4. Patient is on dialysis or has serum creatinine level \\>3.0 mg/dL.\n5. Patient has a pre-existing prosthetic heart valve (aortic or mitral) or a prosthetic ring in any position.\n6. Patient has \\>2+ mitral regurgitation or \\>2+ aortic regurgitation (ie., patient cannot have more than moderate mitral or aortic regurgitation).\n7. Moderate to severe pulmonary hypertension (PA systolic pressure \\>60 mm Hg) as assessed by transthoracic echocardiography.\n8. Patient has a need for emergency surgery for any reason.\n9. Patient has a history of endocarditis within 12 months of index procedure or evidence of an active systemic infection or sepsis.\n10. Patient has echocardiographic evidence of intra-cardiac mass, thrombus or vegetation.\n11. Patient has Hgb \\<9 g/dL, platelet count \\<100,000 cells/mm3 or \\>700,000 cells/mm3, and white blood cell (WBC) count \\<3,000 cells/mm3.\n12. Patient is receiving chronic (≥72 hours) anticoagulation therapy (e.g., heparin, warfarin) and who cannot tolerate concomitant therapy with aspirin and clopidogrel (patients who require chronic anticoagulation must be treated with either aspirin or clopidogrel).\n13. Patient has active peptic ulcer disease, gastrointestinal (GI) bleed within the past 3 months, other bleeding diathesis or coagulopathy or will refuse transfusions.\n14. Patient is contraindicated for transesophageal echocardiography (TEE).\n15. Patient has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to aspirin, all thienopyridines, heparin, nickel, titanium, or polyurethanes.\n16. Patient has a life expectancy of less than 12 months due to non-cardiac, co-morbid conditions based on the assessment of the investigator at the time of enrollment.\n17. Patient has other cardiac devices or hardware with which the study device will interfere with device placement (per physician judgment).\n18. Patient has hypertrophic obstructive cardiomyopathy.\n19. Patient has any therapeutic invasive cardiac procedure within 30 days prior to the index procedure.\n20. Untreated clinically significant coronary artery disease requiring revascularization.\n21. Patient has documented left ventricular ejection fraction (LVEF) \\<30%.\n22. Patient is in cardiogenic shock or has hemodynamic instability requiring inotropic support or mechanical support devices.\n23. Patient has severe peripheral vascular disease (including aneurysm defined as maximal luminal diameter \\>5cm or with documented presence of thrombus, marked tortuosity, narrowing of the abdominal aorta, severe unfolding of the thoracic aorta or thick (\\>5mm), protruding or ulcerated atheroma in the aortic arch) or symptomatic carotid or vertebral disease.\n24. Patient has a femoral artery lumen of \\<6.0 mm or severe iliofemoral tortuosity or calcification that would prevent safe placement of the introducer sheath.\n25. Current problems with substance abuse (e.g. alcohol, cocaine, heroin, etc).\n26. Patient is participating in another investigational drug or device study that has not reached its primary endpoint.\n27. Patient has preexisting untreated conduction system disorders: Type II second-degree atrioventricular (AV) block, bifascicular or trifascicular block.'}, 'identificationModule': {'nctId': 'NCT01383720', 'acronym': 'REPRISE I', 'briefTitle': 'REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve SystEm', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve SystEm', 'orgStudyIdInfo': {'id': 'TP3659'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lotus Valve System', 'description': 'Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis', 'interventionNames': ['Device: Lotus Valve System']}], 'interventions': [{'name': 'Lotus Valve System', 'type': 'DEVICE', 'description': 'The Lotus Valve System includes the Lotus Valve, a bovine tissue tri-leaflet bioprosthetic aortic valve, and the Lotus Delivery Catheter for guidance and placement.', 'armGroupLabels': ['Lotus Valve System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3040', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': "St. Vincent's Hospital", 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3168', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Southern Health Monash Medical Centre', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Ian Meredith, MBBS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southern Health, Monash Medical Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make individual participant data (IPD) available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}