Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-30 @ 3:28 AM
Study NCT ID:
NCT01238835
Status:
COMPLETED
Last Update Posted:
2020-11-02
First Post:
2010-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'THV_CT.gov@edwards.com', 'phone': '949-250-2500', 'title': 'Edwards THV Clinical Affairs', 'organization': 'Edwards Lifesciences'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '5 Years', 'description': 'All adverse events are site reported', 'eventGroups': [{'id': 'EG000', 'title': 'TAVR-TA', 'description': 'Transcatheter valve replacement with transapical access\n\nSAPIEN XT™ Transapical aortic valve replacement: Transcatheter aortic valve implantation via the transapical approach', 'otherNumAtRisk': 218, 'deathsNumAtRisk': 218, 'otherNumAffected': 212, 'seriousNumAtRisk': 218, 'deathsNumAffected': 124, 'seriousNumAffected': 201}], 'otherEvents': [{'term': 'Arrhythmia Supraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 75, 'numAffected': 64}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Bleeding - Procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Coagulopathy / Hematological Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 38, 'numAffected': 34}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Conduction Defects w/o Permanent Pacemaker', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Gastro-Intestinal Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 49, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 27, 'numAffected': 23}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Infection / Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 142, 'numAffected': 94}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Metabolic Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 31, 'numAffected': 27}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Neurological Event Minor - Not Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 29, 'numAffected': 26}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Orthopedic Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 253, 'numAffected': 122}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Peripheral Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 34, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 143, 'numAffected': 130}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Renal Insufficency not requiring Dialysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 39, 'numAffected': 36}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Respiratory Comp / Failure not requ. Resp Assistance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 32, 'numAffected': 25}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Transitory Psychotic Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 39, 'numAffected': 39}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'seriousEvents': [{'term': 'Access Related Complication - Thoracic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Access Related Complication - Ventricle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Annular Dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Arrhythmia Supraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 19, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Arrhythmia Ventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Bleeding - Not Trauma Not Procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Bleeding - Procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 17, 'numAffected': 13}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Bleeding - Trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 24, 'numAffected': 16}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Coagulopathy / Hematological Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 68, 'numAffected': 53}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Conduction Defects w/o Permanent Pacemaker', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Conduction Defects with Permanent Pacemaker', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 35, 'numAffected': 32}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Decubitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Delivery System Malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Drug Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Gastro-Intestinal Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 39, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 90, 'numAffected': 58}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hemodynamic Collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Infection / Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 90, 'numAffected': 62}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Metabolic Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Mitral Regurg. ( 3+ or 4+)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Mitral Valve Compromise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Multiple Organ Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Neurological Event Minor - Not Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Neurological Event Severe - Not Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Non-Struct Valve Dysf. (Not PVL)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Orthopedic Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 23, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 114, 'numAffected': 67}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Perivalvular Leak (1+ or 2+)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Perivalvular Leak (3+ or 4+)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 31, 'numAffected': 28}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Renal Failure requiring Permanent Dialysis (>30d)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Renal Insufficency not requiring Dialysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Renal Insufficiency / Failure requiring Temporary Dialysis (< or = 30d)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 21, 'numAffected': 19}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Respiratory Comp / Failure not requ. Resp Assistance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Respiratory Comp / Failure requ. Resp Assistance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 31, 'numAffected': 25}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Stroke - Embolic / Ischemic Origin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Stroke - Unknown Origin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Struct Valve Deterioration (SVD)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Sudden Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Thoracic Wound Comp.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Transitory Psychotic Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Valve Embolization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Vascular Event (Not Access-Related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 27, 'numAffected': 17}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Ventricular / Myocardial Injury / Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Vision Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR-TA', 'description': 'Transcatheter valve replacement with transapical access\n\nSAPIEN XT™ Transapical aortic valve replacement: Transcatheter aortic valve implantation via the transapical approach'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Number of death at 30-days from the index procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR-TA', 'description': 'Transcatheter valve replacement with transapical access\n\nSAPIEN XT™ Transapical aortic valve replacement: Transcatheter aortic valve implantation via the transapical approach'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30-days', 'description': 'Total Number of Participants with a Stroke.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TAVR-TA', 'description': 'Transcatheter valve replacement with transapical access\n\nSAPIEN XT™ Transapical aortic valve replacement: Transcatheter aortic valve implantation via the transapical approach'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '218'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '136'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '124'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Site early discontinuation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'One patient withdrew from the study prior to procedure and one patient did not continue to procedure due to poor health.', 'preAssignmentDetails': 'Two enrolled subjects did not enter the procedure room.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'TAVR-TA', 'description': 'Transcatheter valve replacement with transapical access\n\nSAPIEN XT™ Transapical aortic valve replacement: Transcatheter aortic valve implantation via the transapical approach'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '81.2', 'spread': '5.46', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '153', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Logistic EuroSCORE', 'classes': [{'categories': [{'measurements': [{'value': '24.0', 'spread': '7.27', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The logistic European System for Cardiac Operative Risk Evaluation (logistic EuroSCORE) measures patient risk of mortality or morbidity at the time of cardiovascular surgery on a scale that ranges from 0% to 100%, with higher numbers indicating greater risk of operative mortality.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'NYHA Class', 'classes': [{'title': 'Class I/II', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}, {'title': 'Class III/IV', 'categories': [{'measurements': [{'value': '182', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'New York Heart Association (NYHA), functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I-IV. I = no limitations of physical activity; II = slight limitations of physical activity, ordinary physical activity results in fatigue, palpitation, shortness of breath; III = marked limitations of physical activity, less than ordinary activity causes fatigue, palpitation, or shortness of breath.; IV = unable to carry on any physical activity without discomfort, symptoms of heart failure at rest.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'As treated population'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-27', 'studyFirstSubmitDate': '2010-01-26', 'resultsFirstSubmitDate': '2020-09-27', 'studyFirstSubmitQcDate': '2010-11-09', 'lastUpdatePostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-27', 'studyFirstPostDateStruct': {'date': '2010-11-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Deaths', 'timeFrame': '30 days', 'description': 'Number of death at 30-days from the index procedure.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With a Stroke', 'timeFrame': '30-days', 'description': 'Total Number of Participants with a Stroke.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sapien XT Valve', 'Valvular Heart Disease', 'Aortic Stenosis', 'Heart Valve Therapy', 'Transapical', 'Transcatheter'], 'conditions': ['Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': 'A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), the next generation Ascendra™ transapical delivery system, and crimper accessories.', 'detailedDescription': 'Purpose: The purpose of this trial is to evaluate the acute safety and effectiveness of the SAPIEN XT™ study valve and next generation Ascendra™ delivery components.\n\nFollow-up Intervals: Subject data collection will include clinical information at baseline and during the index procedure. Subjects will undergo clinical follow-up at discharge, 30 days, 6 month annually for 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n1. EuroSCORE of ≥ 15 %\n2. Severe senile degenerative aortic valve stenosis\n3. Symptomatic aortic valve stenosis\n4. Informed consent\n5. Compliance\n\nExclusion:\n\n1. Logistic Euroscore \\> 40 %\n2. Evidence of an acute myocardial infarction\n3. Congenital unicuspid or congenital bicuspid valve/ non-calcified\n4. Mixed aortic valve disease'}, 'identificationModule': {'nctId': 'NCT01238835', 'briefTitle': 'PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Edwards Lifesciences'}, 'officialTitle': 'Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (TransApical)', 'orgStudyIdInfo': {'id': '2009-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAVR-TA', 'description': 'Transcatheter valve replacement with transapical access', 'interventionNames': ['Device: SAPIEN XT™ Transapical aortic valve replacement']}], 'interventions': [{'name': 'SAPIEN XT™ Transapical aortic valve replacement', 'type': 'DEVICE', 'otherNames': ['Sapien XT', 'Next generation Ascendra delivery system inclusive accessory'], 'description': 'Transcatheter aortic valve implantation via the transapical approach', 'armGroupLabels': ['TAVR-TA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1019', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medizinische Universitat Wien Univ.Klinik f.Chirurgie', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '75018', 'city': 'Paris', 'country': 'France', 'facility': 'Hôspital Bichat', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '29549', 'city': 'Bad Bevensen', 'country': 'Germany', 'facility': 'Herz-Und Gefasszentrum Bad Bevensen', 'geoPoint': {'lat': 53.07923, 'lon': 10.58129}}, {'zip': '61231', 'city': 'Bad Nauheim', 'country': 'Germany', 'facility': 'Kerckhoff-Klinik', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}, {'zip': '97616', 'city': 'Bad Neustadt an der Saale', 'country': 'Germany', 'facility': 'Herz-und-Gefass Klinik', 'geoPoint': {'lat': 50.32174, 'lon': 10.20673}}, {'zip': '32545', 'city': 'Bad Oeynhausen', 'country': 'Germany', 'facility': 'Herz-und Diabeteszentrum NRW', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'zip': '49214', 'city': 'Bad Rothenfelde', 'country': 'Germany', 'facility': 'Schüchtermann-Klinik', 'geoPoint': {'lat': 52.11667, 'lon': 8.16667}}, {'zip': '50924', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Heart Center University Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Herzzentrum Dresden GmbH', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'University Clinic Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '45122', 'city': 'Essen', 'country': 'Germany', 'facility': 'University Hospital Essen, West German Heart Center', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '76185', 'city': 'Karlsruhe', 'country': 'Germany', 'facility': 'Cardiac Surgery Karlsruhe', 'geoPoint': {'lat': 49.00937, 'lon': 8.40444}}, {'zip': '04829', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Heart Center Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '80636', 'city': 'Munich', 'country': 'Germany', 'facility': 'German Heart Center Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '81377', 'city': 'Munich', 'country': 'Germany', 'facility': 'University Hospital Munich-Grosshadern', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '81925', 'city': 'Munich', 'country': 'Germany', 'facility': 'Hospital Munich-Bogenhausen', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '70376', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Robert-Bosch-Krankenhaus', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': 'SE1 7EH', 'city': 'London', 'country': 'United Kingdom', 'facility': "St. Thomas' Hospital - NHS Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Prof. Dr. Thomas Walther', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kerckhoff Klinik'}, {'name': 'Dr. Olaf Wendler', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's College London"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edwards Lifesciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}