Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-02-27 @ 8:26 AM
Study NCT ID:
NCT01876420
Status:
COMPLETED
Last Update Posted:
2018-08-22
First Post:
2013-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': {'phone': '763-526-0309', 'title': 'Terry Noel', 'organization': 'Medtronic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 30 days.', 'description': 'All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'All Attempted Implanted Subjects', 'description': 'Sixty subjects were implanted with the Evolut R valve from six centers in Australia, the United Kingdom, and New Zealand.', 'otherNumAtRisk': 60, 'otherNumAffected': 60, 'seriousNumAtRisk': 60, 'seriousNumAffected': 40}], 'otherEvents': [{'term': 'Anaemias Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Thrombocytopenias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Cardiac Conduction Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 29}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Cardiac Disorders Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Heart Failure Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Ischemic Coronary Artery Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Rate and Rhythm Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Supraventricular Arrythmias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Gastrointestinal Atonic And Hypomobility', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Nausea and Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Gastrointestinal Atonic And HypomobilitySigns and Symptoms Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Febrile Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Inflammations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Complication Associated with Device Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Infections Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Urinary Tract Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Non-site specific Injuries Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Non-site specific Procedural Complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'General Nutrition Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Headach Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Neurological Signs And Symptoms Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Depressive Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Mental Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Renal Failure and Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Urinary Abnormalities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Vulvovaginal Disorder Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Coughing And Associated Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Pneumothorax And Pleural Effusions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Dermatitis And Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Subcutaneous Tissue Ulcerations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Skin injuries And Mechanical Dermatoses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Vascular Hypotensive Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Aortic Valvular Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Ventricular Arrythmias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Blood disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Cardiac Conduction Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Supraventricular arrythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Ischemic Coronary Artery Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Decreased BP', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Gastrointestianl Ulcers and Perforation, Site Unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'General Signs and Symptoms Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Lower Respiratory Tract And Lung Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Diabetes Mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Renal Failure and Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Upper Respiratory Tract Signs and Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}, {'term': 'Dermatitis Ascribed to Specific Agent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 14.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'All-cause Mortality Rate at 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'Sixty subjects were implanted with the Evolut R valve from six centers in Australia, the United Kingdom, and New Zealand.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'The All-cause mortality rate at 30 days per the VARC II recommendation of clinical endpoints for TAVI. More specifically:\n\nCardiovascular mortality (Any of the following criteria)\n\n* Death due to proximate cardiac cause (e.g. myocardial infarction, cardiac tamponade, worsening heart failure)\n* Death caused by non-coronary vascular conditions such as neurological events, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease\n* All procedure-related deaths, including those related to a complication of the procedure or treatment for a complication of the procedure\n* All valve-related deaths including structural or non-structural valve dysfunction or other valve-related adverse events\n* Sudden or unwitnessed death\n* Death of unknown cause Non-cardiovascular mortality\n* Any death in which the primary cause of death is clearly related to another condition (e.g. trauma, cancer, suicide)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All implanted subjects at 30 days.'}, {'type': 'PRIMARY', 'title': 'Stroke Rate (Disabling and Non-disabling) at 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'Sixty subjects were implanted with the Evolut R valve from six centers in Australia, the United Kingdom, and New Zealand.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': "The Stroke rate (disabling and non-disabling) at 30 days per the VARC II definitions. Stroke is defined as an acute episode of focal or global neurological dysfunction caused by the brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction. Stroke may be classified as ischaemic or haemorrhagic with appropriate subdefinitions. Ischaemic stroke is defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central nervous system tissue. Haemorrhagic stroke is defined as an acute episode of focal or global cerebral or spinal dysfunction caused by intraparenchymal, intraventricular, or subarachnoid haemorrhage. A stroke may be classified as 'undetermined' if there is insufficient information to allow the categorization as ischaemic or haemorrhagic.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All implanted subjects at 30 days.'}, {'type': 'PRIMARY', 'title': 'Device Success Rate at 24 Hours to Seven Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'Sixty subjects were implanted with the Evolut R valve from six centers in Australia, the United Kingdom, and New Zealand.'}], 'classes': [{'title': 'Overall Device Success', 'categories': [{'measurements': [{'value': '78.6', 'groupId': 'OG000'}]}]}, {'title': 'Absence of Procedural Mortality', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Correct Positioning of Single Valve', 'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000'}]}]}, {'title': 'Intended Performance of Prosthetic Heart Valve', 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000'}]}]}, {'title': 'Absence of Patient Prosthesis Mismatch', 'categories': [{'measurements': [{'value': '83.6', 'groupId': 'OG000'}]}]}, {'title': 'Mean Gradient < 20mmHg or Peak Velocity < 3m/sec', 'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000'}]}]}, {'title': 'Absence of Mod. or Severe Prosthetic Regurgitation', 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 hours to seven days', 'description': '1. Device success rate at 24 hours to seven days, defined as:\n\n * Absence of procedural mortality, AND\n * Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND\n * Intended performance of the prosthetic heart valve, defined as the absence of patient-prosthesis-mismatch and mean aortic valve gradient less than 20 mmHg (or peak velocity \\< 3 m/sec), AND absence of moderate or severe prosthetic valve regurgitation.\n2. The percentage of subjects with no more than mild aortic regurgitation at early post procedure echocardiogram (24 hours through seven days).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All implanted subjects at 30 days.'}, {'type': 'SECONDARY', 'title': 'VARC II Combined Safety Endpoint at 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'Sixty subjects were implanted with the Evolut R valve from six centers in Australia, the United Kingdom, and New Zealand.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'The VARC II Combined Safety Endpoint at 30 days includes the following components: All-Cause Mortality, All Stroke, Life Threatening or Disabling Bleeding, Acute Kidney Injury: Stage 2 or 3, Coronary Artery Obstruction, Major Vascular Complication, and Valve-Related Dysfunction Requiring Repeat Procedure.', 'unitOfMeasure': 'percentage probability', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Event Rates of the Individual Components of the VARC II Composite Safety Endpoint at 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'Sixty subjects were implanted with the Evolut R valve from six centers in Australia, the United Kingdom, and New Zealand.'}], 'classes': [{'title': 'Combined Safety Endpoint', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}]}]}, {'title': 'All Cause Mortality', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'All Stroke', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Life Threatening or Disabling Bleeding', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}]}]}, {'title': 'Acute Kidney Injury: Stage 2 or 3', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}]}]}, {'title': 'Coronary Artery Obstruction', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Major Vascular Complication', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}]}]}, {'title': 'Valve-Related Dysfunct. Requiring Repeat Procedure', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'The Individual components of the VARC II composite safety endpoint at 30 days per the Kaplan Meier Event Rate (%).', 'unitOfMeasure': 'percentage of probability', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of subjects analyzed at 30 days.'}, {'type': 'SECONDARY', 'title': 'Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - Mean Gradient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'Sixty subjects were implanted with the Evolut R valve from six centers in Australia, the United Kingdom, and New Zealand.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'spread': '3.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'The hemodynamic performance will be measured by the Mean Prosthetic Valve Gradient for 59 subjects, measured with the Doppler echocardiography.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All implanted subjects who had echos at the 30 day visit, which were 58 subjects, only 57 of the echos were able to measure the Mean Gradient for those subjects.'}, {'type': 'SECONDARY', 'title': 'Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - • Effective Orifice Area (EOA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'Sixty subjects were implanted with the Evolut R valve from six centers in Australia, the United Kingdom, and New Zealand.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '0.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Effective orifice area', 'unitOfMeasure': 'cm²', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All implanted subjects who had echos at the 30 day visit, which were 58 subjects, only 54 of the echos were able to measure the EOA for those subjects.'}, {'type': 'SECONDARY', 'title': 'Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - Total Aortic Regurgitation (Transvalvular & Paravalvular)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'Sixty subjects were implanted with the Evolut R valve from six centers in Australia, the United Kingdom, and New Zealand.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000'}]}]}, {'title': 'Trace', 'categories': [{'measurements': [{'value': '22.4', 'groupId': 'OG000'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '63.8', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Degree of Total prosthetic valve regurgitation (transvalvular \\& paravalvular)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All implanted subjects who had echos at the 30 day visit, which were 58 subjects, and 58 of the echos were able to measure the Total Aortic Regurgitation for those subjects.'}, {'type': 'SECONDARY', 'title': 'Resheath or Recapture Success Rate (When Attempted), Where Successful Recapture is Defined as Evolut R™ TAV (Including the Frame) is Fully Resheathed Into the Capsule of the Delivery Catheter, as Verified by Fluoroscopy.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Research recapture attempts', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Implanted Subjects', 'description': 'Sixty subjects were implanted with the Evolut R valve from six centers in Australia, the United Kingdom, and New Zealand.'}], 'classes': [{'title': 'Success rate for Resheath or Recapture', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Success rate for Resheath', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Success rate for Recapture', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Resheath or Recapture success rate (when attempted), where successful recapture is defined as Evolut R™ TAV (including the frame) is fully resheathed into the capsule of the delivery catheter, as verified by fluoroscopy. Resheathing or recapturing of the TAV was attempted on 15 subjects.', 'unitOfMeasure': 'percentage of successful attempts', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Research recapture attempts', 'denomUnitsSelected': 'Research recapture attempts', 'populationDescription': 'Subjects who had either a resheath or recapture attempt at implant and the success rate for each resheathing, or recapturing attempts of the valve at the implant.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Implanted Subjects', 'description': 'Sixty subjects were implanted with the Evolut R valve from six centers in Australia, the United Kingdom, and New Zealand.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Missed 30 day visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'The CoreValve™ Evolut R TAV™ System', 'description': 'CoreValve™ Evolut R™ System which consists of the Evolut R™ Transcatheter Aortic Valve (26 \\& 29 mm sizes), EnVeo R™ Delivery Catheter System with Enveo InLine™ Sheath, and EnVeo R™ Loading System\n\nThe CoreValve™ Evolut R TAV™ system: CoreValve™ Evolut R™ System which consists of the Evolut R™ Transcatheter Aortic Valve (26 \\& 29 mm sizes), EnVeo R™ Delivery Catheter System with Enveo InLine™ Sheath, and EnVeo R™ Loading System'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '82.8', 'spread': '6.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'New Zealand', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'NYHA Class', 'classes': [{'title': 'NYHA I', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'NYHA II', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'NYHA III', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}, {'title': 'NYHA IV', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Class II Subjects with cardiac disease resulting in slight limitation of physical activity. Class III Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.', 'unitOfMeasure': 'participants'}, {'title': 'STS Score', 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'spread': '3.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Society of Thoracic Surgeons (STS) risk model predicts the risk of operative mortality and morbidity after adult cardiac surgery on the basis of patient demographic and clinical variables. After information has been entered on a given case, the online STS risk calculator provides a risk percentage for each of the outcomes. The risk percentage estimates the chance of a specific outcome for a patient with the indicated risk factors. A higher score indicates a higher risk. A lower score indicates a lower risk.', 'unitOfMeasure': 'percent of risk for cardiac surgery', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Logistic EuroScore', 'classes': [{'categories': [{'measurements': [{'value': '20.5', 'spread': '12.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The European System for Cardiac Operative Risk Evaluation (EuroSCORE) is a method of calculating predicted operative mortality for patients undergoing cardiac surgery. If a risk factor is present, a weight/number is assigned. The weights are added to give an approximate percent of predicted mortality. A higher score indicates a higher risk. A lower score indicates a lower risk.', 'unitOfMeasure': 'percent risk for cardiac surgery', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Surface Area (BSA)', 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '0.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'm²', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All implanted subjects'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-21', 'studyFirstSubmitDate': '2013-06-05', 'resultsFirstSubmitDate': '2016-09-30', 'studyFirstSubmitQcDate': '2013-06-11', 'lastUpdatePostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-21', 'studyFirstPostDateStruct': {'date': '2013-06-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause Mortality Rate at 30 Days', 'timeFrame': '30 days', 'description': 'The All-cause mortality rate at 30 days per the VARC II recommendation of clinical endpoints for TAVI. More specifically:\n\nCardiovascular mortality (Any of the following criteria)\n\n* Death due to proximate cardiac cause (e.g. myocardial infarction, cardiac tamponade, worsening heart failure)\n* Death caused by non-coronary vascular conditions such as neurological events, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease\n* All procedure-related deaths, including those related to a complication of the procedure or treatment for a complication of the procedure\n* All valve-related deaths including structural or non-structural valve dysfunction or other valve-related adverse events\n* Sudden or unwitnessed death\n* Death of unknown cause Non-cardiovascular mortality\n* Any death in which the primary cause of death is clearly related to another condition (e.g. trauma, cancer, suicide)'}, {'measure': 'Stroke Rate (Disabling and Non-disabling) at 30 Days', 'timeFrame': '30 days', 'description': "The Stroke rate (disabling and non-disabling) at 30 days per the VARC II definitions. Stroke is defined as an acute episode of focal or global neurological dysfunction caused by the brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction. Stroke may be classified as ischaemic or haemorrhagic with appropriate subdefinitions. Ischaemic stroke is defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central nervous system tissue. Haemorrhagic stroke is defined as an acute episode of focal or global cerebral or spinal dysfunction caused by intraparenchymal, intraventricular, or subarachnoid haemorrhage. A stroke may be classified as 'undetermined' if there is insufficient information to allow the categorization as ischaemic or haemorrhagic."}, {'measure': 'Device Success Rate at 24 Hours to Seven Days', 'timeFrame': '24 hours to seven days', 'description': '1. Device success rate at 24 hours to seven days, defined as:\n\n * Absence of procedural mortality, AND\n * Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND\n * Intended performance of the prosthetic heart valve, defined as the absence of patient-prosthesis-mismatch and mean aortic valve gradient less than 20 mmHg (or peak velocity \\< 3 m/sec), AND absence of moderate or severe prosthetic valve regurgitation.\n2. The percentage of subjects with no more than mild aortic regurgitation at early post procedure echocardiogram (24 hours through seven days).'}], 'secondaryOutcomes': [{'measure': 'VARC II Combined Safety Endpoint at 30 Days', 'timeFrame': '30 days', 'description': 'The VARC II Combined Safety Endpoint at 30 days includes the following components: All-Cause Mortality, All Stroke, Life Threatening or Disabling Bleeding, Acute Kidney Injury: Stage 2 or 3, Coronary Artery Obstruction, Major Vascular Complication, and Valve-Related Dysfunction Requiring Repeat Procedure.'}, {'measure': 'Event Rates of the Individual Components of the VARC II Composite Safety Endpoint at 30 Days', 'timeFrame': '30 days', 'description': 'The Individual components of the VARC II composite safety endpoint at 30 days per the Kaplan Meier Event Rate (%).'}, {'measure': 'Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - Mean Gradient', 'timeFrame': '30 days', 'description': 'The hemodynamic performance will be measured by the Mean Prosthetic Valve Gradient for 59 subjects, measured with the Doppler echocardiography.'}, {'measure': 'Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - • Effective Orifice Area (EOA)', 'timeFrame': '30 days', 'description': 'Effective orifice area'}, {'measure': 'Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - Total Aortic Regurgitation (Transvalvular & Paravalvular)', 'timeFrame': '30 days', 'description': 'Degree of Total prosthetic valve regurgitation (transvalvular \\& paravalvular)'}, {'measure': 'Resheath or Recapture Success Rate (When Attempted), Where Successful Recapture is Defined as Evolut R™ TAV (Including the Frame) is Fully Resheathed Into the Capsule of the Delivery Catheter, as Verified by Fluoroscopy.', 'timeFrame': 'Day 1', 'description': 'Resheath or Recapture success rate (when attempted), where successful recapture is defined as Evolut R™ TAV (including the frame) is fully resheathed into the capsule of the delivery catheter, as verified by fluoroscopy. Resheathing or recapturing of the TAV was attempted on 15 subjects.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Aortic Stenosis']}, 'referencesModule': {'references': [{'pmid': '26315740', 'type': 'DERIVED', 'citation': 'Manoharan G, Walton AS, Brecker SJ, Pasupati S, Blackman DJ, Qiao H, Meredith IT. Treatment of Symptomatic Severe Aortic Stenosis With a Novel Resheathable Supra-Annular Self-Expanding Transcatheter Aortic Valve System. JACC Cardiovasc Interv. 2015 Aug 24;8(10):1359-1367. doi: 10.1016/j.jcin.2015.05.015.'}]}, 'descriptionModule': {'briefSummary': 'To assess the safety and clinical performance of the CoreValve™ Evolut R™ System.', 'detailedDescription': 'The study objectives are to assess the safety and clinical performance of the CoreValve™ Evolut R™ System in patients with severe symptomatic aortic stenosis who are considered at high through extreme risk for surgical aortic valve replacement. These objectives will be accomplished by a prospective clinical study involving up to 60 implanted subjects among up to six study centers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Severe aortic stenosis, defined as aortic valve area of \\< 1.0 cm2 (or aortic valve area index of \\< 0.6 cm2/m2) by the continuity equation, AND mean gradient \\> 40 mmHg or maximal aortic valve velocity \\> 4.0 m/sec by resting echocardiogram.\n2. Estimated 30 day mortality risk of \\> 15% by study center Heart Team assessment,33 OR at least two cardiovascular surgeons from the study center deny surgery because of prohibitive operative risk, estimated to be a combined \\>50% risk of irreversible mortality or morbidity.\n3. Symptoms of aortic stenosis, and NYHA Functional Class II or greater.\n4. The subject meets the legal minimum age to provide informed consent based on local regulatory requirements, and has provided written informed consent as approved by the EC/IRB of the respective clinical site.\n5. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.\n\n Exclusion Criteria:\n\n Clinical exclusion criteria:\n6. Subject has been offered SAVR but has declined.\n7. Any condition considered a contraindication for placement of a bioprosthetic valve (e.g. subject is indicated for mechanical prosthetic valve).\n8. Known hypersensitivity or contraindication to Nitinol.\n9. Blood dyscrasias as defined: leukopenia (WBC \\<1000 mm3), thrombocytopenia (platelet count \\<50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.\n10. Untreated clinically significant coronary artery disease requiring revascularization.\n11. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \\<20% by echocardiography, contrast ventriculography, or radionuclide ventriculography.\n12. End stage renal disease requiring chronic dialysis of creatinine clearance \\< 20 cc/min.\n13. Ongoing sepsis, including active endocarditis.\n14. Any condition considered a contraindication to extracorporeal assistance.\n15. Any percutaneous coronary or peripheral interventional procedure with a bare metal stent performed within 30 days prior to Heart Team assessment, or within six months prior to Heart Team assessment for procedures with a drug eluting stents.\n16. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within eight weeks of Heart Team Assessment .\n17. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.\n18. Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).\n19. Gastrointestinal (GI) bleeding that would preclude anticoagulation.\n20. Subject refuses a blood transfusion.\n21. Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).\n22. Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions.\n23. Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-ups exams.\n24. Currently participating in an investigational drug or another device study (excluding registries).\n25. Evidence of an acute myocardial infarction ≤30 days before the index procedure.\n26. Need for emergency surgery for any reason.\n27. Liver failure (Child-C).\n28. Subject is pregnant or breast feeding.\n\n Anatomical exclusion criteria:\n29. Pre-existing prosthetic heart valve in any position.\n30. Mixed aortic valve disease (aortic stenosis with moderate or severe aortic regurgitation).\n31. Severe mitral regurgitation.\n32. Severe tricuspid regurgitation.\n33. Moderate or severe mitral stenosis.\n34. Hypertrophic obstructive cardiomyopathy.\n35. Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac mass thrombus or vegetation.\n36. Congenital bicuspid or unicuspid valve verified by echocardiography.'}, 'identificationModule': {'nctId': 'NCT01876420', 'briefTitle': 'The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiovascular'}, 'officialTitle': 'The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study', 'orgStudyIdInfo': {'id': 'MDT10093773DOC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The CoreValve™ Evolut R TAV™ system', 'description': 'CoreValve™ Evolut R™ System which consists of the Evolut R™ Transcatheter Aortic Valve (26 \\& 29 mm sizes), EnVeo R™ Delivery Catheter System with Enveo InLine™ Sheath, and EnVeo R™ Loading System', 'interventionNames': ['Device: The CoreValve™ Evolut R TAV™ system']}], 'interventions': [{'name': 'The CoreValve™ Evolut R TAV™ system', 'type': 'DEVICE', 'otherNames': ['CoreValve™ EvolutR™ Transcatheter Ao Valve', 'EnveoR™ Delivery Catheter System w/ Enveo InLine™ Sheath', 'EnVeoR™ Loding System'], 'description': 'CoreValve™ Evolut R™ System which consists of the Evolut R™ Transcatheter Aortic Valve (26 \\& 29 mm sizes), EnVeo R™ Delivery Catheter System with Enveo InLine™ Sheath, and EnVeo R™ Loading System', 'armGroupLabels': ['The CoreValve™ Evolut R TAV™ system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Epworth Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Monash Medical Center', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Hamilton', 'country': 'New Zealand', 'facility': 'Waikato Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}, {'zip': 'BT12 6BA', 'city': 'Belfast', 'country': 'United Kingdom', 'facility': 'Royal Victoria Hospital', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'LS1 3EX', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Leeds General Infirmary', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "St. George's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Eric Vang, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Director Clinical Research Structural Heart'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiovascular', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}