Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT01043705
Status:
COMPLETED
Last Update Posted:
2015-12-24
First Post:
2010-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lynn.landborg@medtronic.com', 'phone': '763 526 2877', 'title': 'Lynn Landborg, Clinical Research Manager', 'organization': 'Medtronic plc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This was a non-randomized study and did not have an active comparator.'}}, 'adverseEventsModule': {'timeFrame': 'During 12 month follow up period', 'description': 'Note that non-serious adverse events were not collected or assessed as part of this study.\n\nAdverse events coded as "death" do not have further description.', 'eventGroups': [{'id': 'EG000', 'title': 'CIED Replacement With CRT and TYRX', 'description': '(Prospective Arm) Patients who have undergone CIED replacement with a CRT and the TYRX Anti-bacterial envelope, with or without lead revision.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 578, 'seriousNumAffected': 96}, {'id': 'EG001', 'title': 'CIED Replacement With ICD and TYRX', 'description': '(Prospective Arm) Patients who have undergone CIED replacement with an ICD and the TYRX Anti-bacterial envelope, with or without lead revision.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 459, 'seriousNumAffected': 46}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Aortic Valve Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Atrial Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardiac Amyloidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardiac Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardio-respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardiogenic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardiopulmonary Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ischemic Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Low Cardiac Output Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Mitral Valve Incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Restrictive Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Tricuspid Valve Incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gastrointestinal Heamorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Lower Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Rectal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Adverse Drug Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Brain Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Complication of Device Removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Condition Aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 45, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Device Component Issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Device Electrical Finding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Device Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Device Lead Damage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Device Lead Issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Device Malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Device Pacing Issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Device Stimulation Issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Feeling Hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'General Physical Health Deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Impaired Healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Implant Site Discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Implant Site Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Implant Site Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Implant Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Medical Device Site Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Multi-Organ Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Multimorbidity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Treatment Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardiac Valve Vegetation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 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'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Skin Erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Aortic Valve Replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardiac Pacemaker Removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardiac Pacemaker Replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardio Pacemaker Revision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardioversion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Chest Tube Insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Drain Placement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Emergency Care', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Endotracheal Intubation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Haemodialysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hospice Care', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Implantable Defibrillator Insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Incisional Drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Mechanical Ventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Medical Device Change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Medical Device Removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Packed Red Blood Cell Transfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Palliative Care', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Rehabilitation Therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Tracheostomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ventricular Assist Device Insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Withdrawal of Life Support', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Wound Drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Distributive Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Peripheral Arterial Occlusive Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Major CIED Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '670', 'groupId': 'OG000'}, {'value': '578', 'groupId': 'OG001'}, {'value': '578', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CIED Replacement With CRT and TYRX', 'description': '(Prospective Arm) Patients who have undergone CIED replacement with a CRT and the TYRX Anti-bacterial envelope, with or without lead revision.'}, {'id': 'OG001', 'title': 'CIED Replacement With CRT and no TYRX', 'description': '(Retrospective Case-Control Arm) Patients who have undergone CIED replacement with a CRT and no TYRX Anti-bacterial envelope, with or without lead revision/addition.'}, {'id': 'OG002', 'title': 'CIED Replacement With CRT and TYRX vs. Case Match Arm', 'description': 'CIED replacement with CRT and TYRX vs. Case Match Arm; CRT patients who have corresponding non-TYRX implant case-match'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1.4'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2.0'}, {'value': '0.7', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '1.6'}]}]}], 'analyses': [{'pValue': '0.0023', 'groupIds': ['OG000', 'OG001'], 'paramType': "One sided Fisher's exact test.", 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.0044', 'ciUpperLimit': '0.009', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0052', 'groupIds': ['OG000', 'OG001'], 'paramType': "1-sided Fisher's Exact Text", 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.002', 'ciUpperLimit': '0.01', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0176', 'groupIds': ['OG000'], 'paramType': "1-sided Fisher's Exact Test", 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.006', 'ciUpperLimit': '0.014', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3764', 'groupIds': ['OG001', 'OG002'], 'paramType': "Fisher's Exact Test", 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.7', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'CIED Major Infections', 'unitOfMeasure': 'percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable patients that have valid entry criteria'}, {'type': 'PRIMARY', 'title': 'CIED Mechanical Complication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '459', 'groupId': 'OG000'}, {'value': '578', 'groupId': 'OG001'}, {'value': '578', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CIED Replacement With ICD and TYRX', 'description': '(Prospective Arm) Patients who have undergone CIED replacement with an ICD and the TYRX Anti-bacterial envelope, with or without lead revision.'}, {'id': 'OG001', 'title': 'CIED Replacement With CRT and no TYRX', 'description': '(Retrospective Case-Control Arm) Patients who have undergone CIED replacement with a CRT and no TYRX Anti-bacterial envelope, with or without lead revision/addition.'}, {'id': 'OG002', 'title': 'CIED Replacement With CRT and TYRX vs. Case Match Arm', 'description': 'CIED replacement with CRT and TYRX vs. Case Match Arm; CRT patients who have corresponding non-TYRX implant case-match'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '5.1'}, {'value': '5.5', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '7.7'}, {'value': '5.4', 'groupId': 'OG002', 'lowerLimit': '3.7', 'upperLimit': '7.5'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate compared to performance goal', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.4', 'ciLowerLimit': '3.3', 'ciUpperLimit': '5.8', 'statisticalMethod': '1-sided Chi-square', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0444', 'groupIds': ['OG000'], 'paramType': 'Rate compared to a performance goal', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.1', 'ciLowerLimit': '1.7', 'ciUpperLimit': '5.1', 'statisticalMethod': '1-sided Chi-square test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'rate compared to performance goal', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.4', 'ciLowerLimit': '3.8', 'ciUpperLimit': '5.4', 'groupDescription': 'All types of mechanical complications combined.', 'statisticalMethod': '1-sided Chi-squared test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0745', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Descriptive', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.4', 'ciLowerLimit': '3.7', 'ciUpperLimit': '7.5', 'groupDescription': 'All mechanical complications, retrospective, non-TYRX cohort', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'All mechanical Complications related to CIED Implant', 'unitOfMeasure': 'percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'TYRX implants vs. published comparator are "prospective arm" patients. Non-TYRX CIED retrospective arm vs. TYRX CIED replacements are nested, case-control cohort.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ICD With TYRX Implant', 'description': 'All patients receiving a TYRX envelope who were eligible to participate having a replacement ICD implant'}, {'id': 'FG001', 'title': 'CRT and TYRX Cases, Matched to Retrospective Non-TYRX Implants', 'description': 'Patients receiving a TYRX envelope who were eligible to participate having a replacement CRT implant who have a valid non-TYRX implant case-match'}, {'id': 'FG002', 'title': 'CRT With no TYRX Retrospective Case Control', 'description': 'Retrospective site matched and case-matched CRT replacement patients who did not receive a TYRX envelope selected in the era just prior to availability of TYRX Envelope'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '459'}, {'groupId': 'FG001', 'numSubjects': '578'}, {'groupId': 'FG002', 'numSubjects': '578'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '352'}, {'groupId': 'FG001', 'numSubjects': '447'}, {'groupId': 'FG002', 'numSubjects': '498'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '131'}, {'groupId': 'FG002', 'numSubjects': '80'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '26'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Multiple Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Site Closure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Subsequent Procedure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '29'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Screen Fail', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '25'}]}]}], 'recruitmentDetails': 'First Patient Enrolled = 1 January 2010; Last Patient Enrolled = 7 May 2013', 'preAssignmentDetails': 'CRT and ICD Implant patients with TYRX Implant; Full analysis cohort = 1,129 patients. 670 patient CRT + TYRX cohort is subset. 459 patient ICD + TYRX is subset. 578 CRT+ TYRX patient cohort is subset matched to 578 patient CRT/no TYRX retrospective patient arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '459', 'groupId': 'BG000'}, {'value': '578', 'groupId': 'BG001'}, {'value': '578', 'groupId': 'BG002'}, {'value': '1615', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'CIED Replacement With ICD and TYRX', 'description': '(Prospective Arm) Patients who have undergone CIED replacement with an ICD and the TYRX Anti-bacterial envelope, with or without lead revision.'}, {'id': 'BG001', 'title': 'CIED Replacement With CRT and no TYRX', 'description': '(Retrospective Case-Control Arm) Patients who have undergone CIED replacement with a CRT and no TYRX Anti-bacterial envelope, with or without lead revision/addition.'}, {'id': 'BG002', 'title': 'CIED Replacement With CRT and TYRX Vs. Case Match Arm', 'description': 'Prospective CRT patients who received a TYRX envelope and had a valid case match retrospective patient. This is a subset of all CRT/TYRX patients'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70', 'spread': '12.01', 'groupId': 'BG000'}, {'value': '73', 'spread': '10.94', 'groupId': 'BG001'}, {'value': '73', 'spread': '10.70', 'groupId': 'BG002'}, {'value': '72', 'spread': '11.45', 'groupId': 'BG003'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '339', 'groupId': 'BG000'}, {'value': '434', 'groupId': 'BG001'}, {'value': '444', 'groupId': 'BG002'}, {'value': '1217', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}, {'value': '398', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Prospective Population: ICD and CRT replacement implant patients receiving a TYRX Envelope Retrospective Population: CRT Patients receiving a CRT and no TYRX envelope. Patients are site medical charts from just previous to use of TYRX Evelope'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1262}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-20', 'studyFirstSubmitDate': '2010-01-05', 'resultsFirstSubmitDate': '2015-10-13', 'studyFirstSubmitQcDate': '2010-01-06', 'lastUpdatePostDateStruct': {'date': '2015-12-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-20', 'studyFirstPostDateStruct': {'date': '2010-01-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major CIED Infection', 'timeFrame': '12 months', 'description': 'CIED Major Infections'}, {'measure': 'CIED Mechanical Complication', 'timeFrame': '12 months', 'description': 'All mechanical Complications related to CIED Implant'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pacemaker infection', 'Defibrillator infection', 'ICD infection', 'CRT infection', 'Cardiovascular implantable electronic device infection', 'Infection', 'Pacemaker, Artificial', 'Defibrillators'], 'conditions': ['Cardiac Implantable Electronic Device Infection']}, 'referencesModule': {'references': [{'pmid': '23972346', 'type': 'BACKGROUND', 'citation': 'Sohail MR, Henrikson CA, Braid-Forbes MJ, Forbes KF, Lerner DJ. Comparison of mortality in women versus men with infections involving cardiovascular implantable electronic device. Am J Cardiol. 2013 Nov 1;112(9):1403-9. doi: 10.1016/j.amjcard.2013.06.031. Epub 2013 Aug 22.'}, {'pmid': '22529239', 'type': 'BACKGROUND', 'citation': 'Ballo P, Chiodi L, Zuppiroli A. Cardiac implantable electronic devices: prevention starts from ethics. Arch Intern Med. 2012 Apr 23;172(8):670-1; author reply 671-2. doi: 10.1001/archinternmed.2012.346. No abstract available.'}, {'pmid': '29759500', 'type': 'DERIVED', 'citation': 'Henrikson CA, Sohail MR, Acosta H, Johnson EE, Rosenthal L, Pachulski R, Dan D, Paladino W, Khairallah FS, Gleed K, Hanna I, Cheng A, Lexcen DR, Simons GR. Antibacterial Envelope Is Associated With Low Infection Rates After Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Device Replacement: Results of the Citadel and Centurion Studies. JACC Clin Electrophysiol. 2017 Oct;3(10):1158-1167. doi: 10.1016/j.jacep.2017.02.016. Epub 2017 May 31.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the incidence of cardiac implantable electronic device (CIED) infection and CIED mechanical complication after CIED replacement with a high-power cardiac implantable electronic device; either a cardiac resynchronization therapy device (CRT), or an implantable cardioverter defibrilator (ICD) and TYRX Anti-Bacterial Envelope (formerly known as "AIGISRx"), to the incidence, after replacement with an ICD or CRT and no TYRX.', 'detailedDescription': 'Cardiac implantable electronic device (CIED) infection is associated with significant morbidity and expense. The frequency of CIED infection is increasing faster than the frequency of CIED implants, suggesting more effective prophylactic strategies are needed.\n\nThe TYRX Anti-Bacterial Envelope is an FDA-cleared polypropylene mesh that is intended to securely hold a pacemaker pulse generator or defibrillator (ICD) in order to create a stable environment when implanted in the body. It contains the antimicrobial agents, rifampin and minocycline, which have been shown to reduce infection in an in vivo model of bacterial contamination following surgical implant of the generator or defibrillator.\n\nThis is a prospective, observational, multicenter registry of subjects undergoing CIED replacement with an ICD or CRT and TYRX, with or without lead revision/addition. The registry subjects will be compared to a published historical control group undergoing CIED replacement with an ICD or CRT and no TYRX , with or without lead revision/addition. The CRT registry subjects will also be compared to a case-matched retrospective control group undergoing CIED replacement with a CRT and no TYRX , with or without lead revision/addition. The primary study endpoints are major CIED infection and CIED mechanical complication during the 12 months following CIED replacement with an ICD or CRT.\n\nOriginally executed as two separate studies (Citadel - ICDs) and (Centurion - CRTs), a protocol amendment was executed in 2012 due to slow enrollment, combining the databases for analysis of results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have undergone CIED replacement with an ICD or CRT, with or without (CRT retrospective group only) an TYRX Anti-bacterial Envelope, at US medical centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: - Prospective Arms\n\n* Qualifying CIED Implant procedure was replacement with an ICD or CRT and TYRX, with or without lead revision/addition\n* Received a complete TYRX Anti-Bacterial Envelope Model# 3122 or #3133 according to the Instructions for Use (IFU)\n* Clinically stable to tolerate procedure\n* 18 years or older\n* Able to return for follow-up care through the 12-month visit, or able to have referring physician provide follow-up data to study site by telephone\n\nExclusion Criteria: - Prospective Arm\n\n* Unable/unwilling to provide informed consent\n* Contraindication to receiving the TYRX device, in accordance with the package labeling\n* Pregnant or was at risk for becoming pregnant in the 30 day period following the Qualifying TYRX Implant\n* Current CIED infection, or the indication for Qualifying CIED Implant was replacement of CIED that was explanted for infection\n* Clinical diagnosis of an active infection at the time of CIED implant, including pneumonia, urinary tract infection, endovascular, cellulitis, bacteremia, or other major systemic infection. (Note: asymptomatic bacteremia without UTI is not an exclusion criterion)\n* Generator replacement required planned lead extraction\n* Participating in another clinical study evaluating a drug or device designed to reduce CIED infections\n* Life expectancy of less than 6 months\n* Expected to receive a heart transplant within 6 months\n* With the exception of the elderly in good mental health, all vulnerable subjects as defined by the FDA Office of Human Research Protection or local IRB will be excluded\n\nInclusion Criteria: - Case-matched retrospective Control Arm\n\n* Qualifying CIED Implant was replacement with a CRT and TYRX, with or without lead revision/addition\n* First un-enrolled patient meeting case-matching criteria in series of patients implanted with a CIED and no TYRX beginning 24 months prior to the date of first TYRX implant at site. If no matching patients in this period, first un-enrolled matching patient implanted with a CIED and no TYRX beginning 24 months prior to the first TYRX implant at site, searching in reverse chronological order\n* Had at least one of following by date of enrollment into the study:\n\n 1. ≥ 12 months follow-up after Qualifying TYRX Implant\n 2. Subsequent TYRX Procedure that required opening the generator pocket or implant incision ≤ 12 months after Qualifying TYRX Implant (e.g. battery change, upgrade, lead revision, explant)\n 3. Death ≤ 12 months after Qualifying CIED Implant\n* Survived Qualifying CIED Implant to discharge, died of a CIED infection or Mechanical Complication prior to hospital discharge, or died for any reason un-related to Qualifying CIED Implant prior to hospital discharge\n* 18 years or older\n\nExclusion Criteria: - Case-matched retrospective Control Arm\n\n* Contraindication to receiving the TYRX device, in accordance with the package labeling\n* Pregnant or became pregnant in the 30 day period following the Qualifying TYRX Implant.\n* CIED infection, or the indication for Qualifying CIED Implant was replacement of CIED that was explanted for infection\n* Clinical diagnosis of an active infection at the time of Qualifying CIED Implant, including pneumonia, urinary tract infection, endovascular, cellulitis, bacteremia, or other major systemic infection (Note: asymptomatic bacteriuria without UTI is not an exclusion criterion)\n* Lead extraction was performed at the Qualifying CIED Implant\n* Participated in another clinical study evaluating a drug or device intended to reduce CIED infections\n* Received a heart transplant within 6 months of Qualifying CIED Implant\n* With the exception of the elderly in good mental health, all vulnerable subjects as defined by the FDA Office of Human Research Protection or local IRB will be excluded'}, 'identificationModule': {'nctId': 'NCT01043705', 'acronym': 'Centurion', 'briefTitle': 'TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD', 'nctIdAliases': ['NCT01043861'], 'organization': {'class': 'INDUSTRY', 'fullName': 'TYRX, Inc.'}, 'officialTitle': 'Centurion and Citadel Studies of TYRX™ Anti-Bacterial Envelope and Custom Mesh for Prevention of Infection Following CIED Replacement With a CRT or ICD', 'orgStudyIdInfo': {'id': 'CP-2009-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CIED replacement with CRT and TYRX', 'description': '(Prospective Arm) Patients who have undergone CIED replacement with a CRT and the TYRX Anti-bacterial envelope, with or without lead revision.'}, {'label': 'CIED replacement with ICD and TYRX', 'description': '(Prospective Arm) Patients who have undergone CIED replacement with an ICD and the TYRX Anti-bacterial envelope, with or without lead revision.'}, {'label': 'CIED replacement with ICD or CRT and TYRX', 'description': '(Prospective Arm) Patients who have undergone CIED replacement with an ICD or CRT and the TYRX Anti-bacterial envelope, with or without lead revision.'}, {'label': 'CIED replacement w/ CRT & no TYRX', 'description': '(Retrospective Case-Control Arm) Patients who have undergone CIED replacement with a CRT and no TYRX Anti-bacterial envelope, with or without lead revision/addition.'}, {'label': 'CIED replacement w/ CRT & TYRX vs. Case Match Arm', 'description': 'Patients who have undergone CIED replacement with a CRT and TYRX Anti-bacterial envelope, with or without lead revision/addition. Cohort is TYRX Case, Matched to Retrospective Case-Control Arm)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35211', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Princeton Medical Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35601', 'city': 'Decatur', 'state': 'Alabama', 'country': 'United States', 'facility': 'Decatur General Hospital', 'geoPoint': {'lat': 34.60593, 'lon': -86.98334}}, {'zip': '35630', 'city': 'Florence', 'state': 'Alabama', 'country': 'United States', 'facility': 'Eliza Coffee Memorial Hospital', 'geoPoint': {'lat': 34.79981, 'lon': -87.67725}}, {'zip': '35901', 'city': 'Gadsden', 'state': 'Alabama', 'country': 'United States', 'facility': 'Riverview Regional Hospital', 'geoPoint': {'lat': 34.01434, 'lon': -86.00639}}, {'zip': '85251', 'city': 'Scottsdate', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Heart Hospital'}, {'zip': '93003', 'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'Community Memorial Hospital', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}, {'zip': '95076', 'city': 'Watsonville', 'state': 'California', 'country': 'United States', 'facility': 'Watsonville Community Hospital', 'geoPoint': {'lat': 36.91023, 'lon': -121.75689}}, {'zip': '34452', 'city': 'Inverness', 'state': 'Florida', 'country': 'United States', 'facility': 'Citrus Memorial Hospital', 'geoPoint': {'lat': 28.83582, 'lon': -82.33037}}, {'zip': '34741', 'city': 'Kissimmee', 'state': 'Florida', 'country': 'United States', 'facility': 'Osceola Regional Medical Center', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Regional Hospital', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Tallahassee Memorial Hospital', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Medical Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30345', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Veteran's Administration Medical Center", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Wellstar Kennestone Hospital', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '61201', 'city': 'Rock Island', 'state': 'Illinois', 'country': 'United States', 'facility': 'Trinity Medical Center', 'geoPoint': {'lat': 41.50948, 'lon': -90.57875}}, {'zip': '62769', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': "St. John's Hospital", 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '46342', 'city': 'Hobart', 'state': 'Indiana', 'country': 'United States', 'facility': "St. Mary's Medical", 'geoPoint': {'lat': 41.53226, 'lon': -87.25504}}, {'zip': '46321', 'city': 'Munster', 'state': 'Indiana', 'country': 'United States', 'facility': 'Community Hospital, Munster', 'geoPoint': {'lat': 41.56448, 'lon': -87.51254}}, {'zip': '46321', 'city': 'Munster', 'state': 'Indiana', 'country': 'United States', 'facility': 'St. Margaret Mercy', 'geoPoint': {'lat': 41.56448, 'lon': -87.51254}}, {'zip': '71201', 'city': 'Monroe', 'state': 'Louisiana', 'country': 'United States', 'facility': 'P and S Surgical Hospital', 'geoPoint': {'lat': 32.50931, 'lon': -92.1193}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21804', 'city': 'Salisbury', 'state': 'Maryland', 'country': 'United States', 'facility': 'Penninsula Regional Medical Center', 'geoPoint': {'lat': 38.36067, 'lon': -75.59937}}, {'zip': '02144', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Medical School', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48910', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Sparrow Hospital', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '39532', 'city': 'Biloxi', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Gulfport Memorial Hospital', 'geoPoint': {'lat': 30.39603, 'lon': -88.88531}}, {'zip': '39534', 'city': 'Biloxi', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Keesler Air Force Base Hospital', 'geoPoint': {'lat': 30.39603, 'lon': -88.88531}}, {'zip': '39401', 'city': 'Hattiesburg', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Southern Heart Center', 'geoPoint': {'lat': 31.32712, 'lon': -89.29034}}, {'zip': '68124', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Alegent Health', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '07631', 'city': 'Englewood', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Englewood Hospital and Medical Center', 'geoPoint': {'lat': 40.89288, 'lon': -73.97264}}, {'zip': '08690', 'city': 'Hamilton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'St. Francis Hospital', 'geoPoint': {'lat': 40.20706, 'lon': -74.08125}}, {'zip': '07112', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Newark Beth Israel Hospital', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '07450', 'city': 'Ridgewood', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Valley Hospital', 'geoPoint': {'lat': 40.97926, 'lon': -74.11653}}, {'zip': '08080', 'city': 'Sewell', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Our Lady of Lourdes Hospital', 'geoPoint': {'lat': 39.7665, 'lon': -75.14434}}, {'zip': '10025', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "St. Luke's - Roosevelt Hospital", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28601', 'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Frye Regional Medical Center', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '44510', 'city': 'Youngstown', 'state': 'Ohio', 'country': 'United States', 'facility': 'Catholic Health Partners', 'geoPoint': {'lat': 41.09978, 'lon': -80.64952}}, {'zip': '18901', 'city': 'Doylestown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Doylestown Hospital', 'geoPoint': {'lat': 40.31011, 'lon': -75.12989}}, {'zip': '17110', 'city': 'Harrisburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pinnacle Health Harrisburg Hospital', 'geoPoint': {'lat': 40.2737, 'lon': -76.88442}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '17403', 'city': 'York', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'York Hospital', 'geoPoint': {'lat': 39.9626, 'lon': -76.72774}}, {'zip': '02895', 'city': 'Woonsocket', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Landmark Medical Center', 'geoPoint': {'lat': 42.00288, 'lon': -71.51478}}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Stern Cardiovascular Foundation', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tenn. Medical Center - Knoxville', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Heart Institute - St. Luke's Episcopal Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'NE Methodist', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Aurora Health Care', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TYRX, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}