Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-30 @ 7:23 PM
Study NCT ID:
NCT01085435
Status:
COMPLETED
Last Update Posted:
2025-05-20
First Post:
2010-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Boston Scientific Post Market Subcutaneous-Implantable Cardioverter Defibrillator (S-ICD) Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017180', 'term': 'Tachycardia, Ventricular'}], 'ancestors': [{'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jens.goetzke@bsci.com', 'phone': '1-800-227-3422', 'title': 'Jens Goetzke', 'organization': 'Boston Scientific'}, 'certainAgreement': {'otherDetails': 'Consultant (PI) acknowledges and agrees that (i) Consultant shall not publish any data, report, white papers or other materials arising out of the Services performed pursuant to this Agreement without the prior written consent of Boston Scientific, and (ii) any such publication shall not include Boston Scientific Confidential Information except prior written consent of Boston Scientific.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From enrollment to 5-year annual visit.', 'eventGroups': [{'id': 'EG000', 'title': 'EFFORTLESS Main Study', 'description': "Patients implanted with a CE marked S-ICD System, not participating in Cameron Health's Investigational Device Exemption (IDE) Clinical Study.\n\nS-ICD System: The S-ICD System is an implantable technology that uses a subcutaneous pulse generator and subcutaneous electrode system to treat ventricular tachyarrhythmias. The S-ICD System consists of the pulse generator, subcutaneous electrode, the programmer and electrode insertion tool.", 'otherNumAtRisk': 984, 'deathsNumAtRisk': 984, 'otherNumAffected': 531, 'seriousNumAtRisk': 984, 'deathsNumAffected': 91, 'seriousNumAffected': 199}], 'otherEvents': [{'term': 'Inappropriate Shock: SVT Above Discrimination Zone (Normal Device Function)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 35, 'numAffected': 23}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inappr. Shock: Conv. bef. shock (Normal Function)', 'notes': 'Inappropriate Shock: Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) spontaneously converted immediately before shock (Normal Device Function)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inappropriate Shock: Cardiac Oversensing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 148, 'numAffected': 105}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse Reaction (Bradycardia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inappropriate Shock: Non-Cardiac Oversensing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 28, 'numAffected': 25}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse Reaction (Medications)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inappropriate Shock: Discrimination Error', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse Reaction (Respiratory)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Phantom Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Premature Cell Battery Depletion: Premature Declaration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Fibrillation/Flutter (Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Premature Cell Battery Depletion: Random Component Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding (Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'PG Movement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inability to Communicate with the Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Phantom Vibration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Phantom Beeps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 87, 'numAffected': 74}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Imminent Erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Electrode Movement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fear of Shocks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Electrode damaged and replaced during concomitant device procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suspected Device Malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Undersensing: Defibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fluid Accumulation (Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Programmer/Software Error code', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inappropriate Post Shock Pacing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 34, 'numAffected': 30}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inadequate Pocket Size', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inadequate/Prolonged Healing of Incision Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Incision/Superficial Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Keloid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nerve Damage (Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'System Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 26, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sub-optimal Electrode position', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope (Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sub-optimal PG position', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sub-optimal PG and Electrode position', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Redness/Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Subcutaneous Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suture Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Device Malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other (Procedure related: PG)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other (Procedure related: Electrode)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Fibrillation/Flutter (Cardiac)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 74, 'numAffected': 34}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart Failure/Worsening of Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 87, 'numAffected': 48}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope (Cardiac)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 27, 'numAffected': 22}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Near Syncope/Dizziness/Shortness of Breath/Confusion (Cardiac)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 21, 'numAffected': 19}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'VT below Conditional Zone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening of VT/VF', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 105, 'numAffected': 69}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 42, 'numAffected': 34}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain (Cardiac)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 28, 'numAffected': 24}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral Vascular Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia/AV Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inflammation (Cardiac)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Right Bundle Branch Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke (Non-System/Non-Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope (Non-Cardiac/Non-System/Non-Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection not related to S-ICD System', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 26, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma (Non-System/Non-Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma (Post Explant of S-ICD System)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Near Syncope/Dizziness/Shortness of Breath/Confusion (Non-Cardiac/Non-System/Non-Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Shortness of Breath, Dyspnea (Non-Cardiac/Non-System/Non-Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychological Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain/Discomfort (Non-Cardiac/Non-System/Non-Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 27, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural Effusion (Non-System/Non-Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'GI Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 37, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal Thyroid Condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding (Non-System/Non-Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea/Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Repositioning of Any Concomitant Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Implant/Replacement of Any Concomitant Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inflammation (Non-Cardiac/Non-System/Non-Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fracture/Broken Bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 16, 'numAffected': 12}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Trauma (Non-Cardiac/Non-System/Non-Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'HEENT Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 18, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fluid Accumulation (Non-Cardiac/Non-System/Non-Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Flu', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Genital/Urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other (Non-Cardiac/Non-System/Non-Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolic Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal Lab Values', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mitral Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other: Cardiac (Non-System/Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Failure (Non-Cardiac/Non-System/Non-Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Unable to Convert: During Procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse Reaction (Medications) (Non-System/Non-Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Altered Mental Status', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle Stimulation (Non-System/Non-Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'SVT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Unable to Convert: During Spontaneous Episode', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Inappropriate Shock: SVT Above Discrimination Zone (Normal Device Function)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inappropriate Shock: Cardiac Oversensing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inappropriate Shock: Non-Cardiac Oversensing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'PG Movement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inability to Communicate with the Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fear of Shocks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Imminent Erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suspected Device Malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Incision/Superficial Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'System Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Fibrillation/Flutter (Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sub-optimal Electrode position', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse Reaction (Medications)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse Reaction (General)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Electrode Movement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding (Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Postoperative Limited Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Fibrillation/Flutter (Cardiac)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart Failure/Worsening of Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 53, 'numAffected': 46}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope (Cardiac)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening of VT/VF', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 18, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain (Cardiac)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral Vascular Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia/AV Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Right Bundle Branch Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke (Non-System/Non-Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection not related to S-ICD System', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychological Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain/Discomfort (Non-Cardiac/Non-System/Non-Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumothorax (Non-System/Non-Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'GI Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal Thyroid Condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding (Non-System/Non-Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Implant/Replacement of Any Concomitant Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fracture/Broken Bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Trauma (Non-Cardiac/Non-System/Non-Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'HEENT Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'notes': 'Cause unknown, no information available to determine the cause of the death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other (Non-Cardiac/Non-System/Non-Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolic Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Multi-system Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other: Cardiac (Non-System/Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Failure (Non-Cardiac/Non-System/Non-Procedure related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Unable to Convert: During Procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 984, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Perioperative S-ICD Complication Free Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '984', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EFFORTLESS Main Study', 'description': "Patients implanted with a CE marked S-ICD System, not participating in Cameron Health's Investigational Device Exemption (IDE) Clinical Study.\n\nS-ICD System: The S-ICD System is an implantable technology that uses a subcutaneous pulse generator and subcutaneous electrode system to treat ventricular tachyarrhythmias. The S-ICD System consists of the pulse generator, subcutaneous electrode, the programmer and electrode insertion tool."}], 'classes': [{'categories': [{'measurements': [{'value': '983', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days post implant', 'description': 'The number of subjects without Type I Complications within 30 Days of Implant divided by the Total Implanted Subjects.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All implanted patients (N=984)'}, {'type': 'PRIMARY', 'title': '360 Day S-ICD Complication Free Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '984', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EFFORTLESS Main Study', 'description': "Patients implanted with a CE marked S-ICD System, not participating in Cameron Health's Investigational Device Exemption (IDE) Clinical Study.\n\nS-ICD System: The S-ICD System is an implantable technology that uses a subcutaneous pulse generator and subcutaneous electrode system to treat ventricular tachyarrhythmias. The S-ICD System consists of the pulse generator, subcutaneous electrode, the programmer and electrode insertion tool."}], 'classes': [{'categories': [{'measurements': [{'value': '970', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Minimum 360 days post implant', 'description': 'The Kaplan-Meier (KM) Survival Estimate of 360-Day Type I Complications.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All implanted patients (N=984)'}, {'type': 'PRIMARY', 'title': 'Percentage of Inappropriate Shocks for Atrial Fibrillation (AF)/Supraventricular Tachycardia (SVT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '984', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EFFORTLESS Main Study', 'description': "Patients implanted with a CE marked S-ICD System, not participating in Cameron Health's Investigational Device Exemption (IDE) Clinical Study.\n\nS-ICD System: The S-ICD System is an implantable technology that uses a subcutaneous pulse generator and subcutaneous electrode system to treat ventricular tachyarrhythmias. The S-ICD System consists of the pulse generator, subcutaneous electrode, the programmer and electrode insertion tool."}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From enrollment to 5-year annual visit.', 'description': 'The number of subjects who received at least one inappropriate shock for SVT above the discrimination zone and SVT discriminator errors divided by the total implanted subjects.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All implanted patients (N=984)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Extension Phase Rate of Long-term S-ICD System-related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Phase Sub Study', 'description': 'Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry'}], 'classes': [{'title': '240 Days Post Replacement Procedure', 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000', 'lowerLimit': '92.1', 'upperLimit': '98.0'}]}]}, {'title': '360 Days Post Replacement Procedure', 'categories': [{'measurements': [{'value': '94.6', 'groupId': 'OG000', 'lowerLimit': '91.4', 'upperLimit': '97.7'}]}]}, {'title': '720 Days Post Replacement Procedure', 'categories': [{'measurements': [{'value': '93.6', 'groupId': 'OG000', 'lowerLimit': '90.2', 'upperLimit': '96.9'}]}]}, {'title': '1080 Days Post Replacement Procedure', 'categories': [{'measurements': [{'value': '92.6', 'groupId': 'OG000', 'lowerLimit': '88.9', 'upperLimit': '96.2'}]}]}, {'title': '1440 Days Post Replacement Procedure', 'categories': [{'measurements': [{'value': '92.0', 'groupId': 'OG000', 'lowerLimit': '88.3', 'upperLimit': '95.8'}]}]}, {'title': '1800 Days Post Replacement Procedure', 'categories': [{'measurements': [{'value': '90.5', 'groupId': 'OG000', 'lowerLimit': '86.2', 'upperLimit': '94.8'}]}]}, {'title': '2160 Days Post Replacement Procedure', 'categories': [{'measurements': [{'value': '89.3', 'groupId': 'OG000', 'lowerLimit': '84.6', 'upperLimit': '94.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'Rate of adverse events related to the S-ICD system in subjects of the EFFORTLESS Extension Phase sub study', 'unitOfMeasure': 'Percentage of Survival w/o l-term AE', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Extension Phase S-ICD Replacements for Functionality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}, {'units': 'S-ICD replacements for functionality', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Phase Sub Study', 'description': 'Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry'}], 'classes': [{'title': 'Battery: Early Battery Depletion', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Inappropriate Shocks', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Change in Indication: Need Bi-V Pacing', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Change in Indication: Need Additional ICD Programmability for VT', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Change in Indication: Need Bradycardia Pacing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Discretion', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'MRI Compatibility', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'S-ICD PG Suspected Malfunction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Unknown reason for out of service', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From enrollment into the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'Number of S-ICD replacements with another type of implantable defibrillator for functionality unavailable with an S-ICD, such as a need for additional brady therapy, cardiac resynchronization therapy, antitachycardia pacing, or other similar reasons', 'unitOfMeasure': 'Subjects w. repl. for functionality', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'S-ICD replacements for functionality', 'denomUnitsSelected': 'S-ICD replacements for functionality', 'populationDescription': 'All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Extension Phase Device Longevity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}, {'units': 'pulse generators', 'counts': [{'value': '418', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Phase Sub Study', 'description': 'Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry'}], 'classes': [{'title': 'PG Model 1010', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}, {'units': 'pulse generators', 'counts': [{'value': '209', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2063.7', 'spread': '494.1', 'groupId': 'OG000'}]}]}, {'title': 'PG Model A209', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}, {'units': 'pulse generators', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1539.1', 'spread': '676.6', 'groupId': 'OG000'}]}]}, {'title': 'PG Model A219', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}, {'units': 'pulse generators', 'counts': [{'value': '190', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1485.5', 'spread': '630.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'Minimum Implant Time (Days). The data includes information on devices tracked from the date of implant until they went out of service, as well as devices tracked from implant until the last available follow-up before the subject exited the study for any reason (such as study conclusion, death, or withdrawal). Devices still functioning at the end of their observation period continue to add to their longevity beyond this period. Thus, the reported value underestimates actual device longevity, representing only the minimum duration these devices were known to function.', 'unitOfMeasure': 'Minimum Implant time [days]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'pulse generators', 'denomUnitsSelected': 'pulse generators', 'populationDescription': 'All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Extension Phase Rate of Complications Related to the S-ICD Replacements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Phase Sub Study', 'description': 'Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry'}], 'classes': [{'title': '240 Days Post Replacement Procedure', 'categories': [{'measurements': [{'value': '92.1', 'groupId': 'OG000', 'lowerLimit': '88.4', 'upperLimit': '95.8'}]}]}, {'title': '360 Days Post Replacement Procedure', 'categories': [{'measurements': [{'value': '91.1', 'groupId': 'OG000', 'lowerLimit': '87.2', 'upperLimit': '95.0'}]}]}, {'title': '720 Days Post Replacement Procedure', 'categories': [{'measurements': [{'value': '87.1', 'groupId': 'OG000', 'lowerLimit': '82.5', 'upperLimit': '91.7'}]}]}, {'title': '1080 Days Post Replacement Procedure', 'categories': [{'measurements': [{'value': '83.6', 'groupId': 'OG000', 'lowerLimit': '78.5', 'upperLimit': '88.7'}]}]}, {'title': '1440 Days Post Replacement Procedure', 'categories': [{'measurements': [{'value': '79.6', 'groupId': 'OG000', 'lowerLimit': '74.0', 'upperLimit': '85.2'}]}]}, {'title': '1800 Days Post Replacement Procedure', 'categories': [{'measurements': [{'value': '77.0', 'groupId': 'OG000', 'lowerLimit': '70.9', 'upperLimit': '83.1'}]}]}, {'title': '2160 Days Post Replacement Procedure', 'categories': [{'measurements': [{'value': '77.0', 'groupId': 'OG000', 'lowerLimit': '70.6', 'upperLimit': '83.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'K-M Estimate (%) for freedom of complications related to the S-ICD replacements', 'unitOfMeasure': 'percentage of freedom from complications', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Extension Phase Appropriate Shock Therapy for VT/VF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Phase Sub Study', 'description': 'Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry'}], 'classes': [{'title': '240 Days Post Implant', 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '96.8', 'upperLimit': '100.0'}]}]}, {'title': '360 Days Post Implant', 'categories': [{'measurements': [{'value': '98.0', 'groupId': 'OG000', 'lowerLimit': '96.1', 'upperLimit': '99.9'}]}]}, {'title': '720 Days Post Implant', 'categories': [{'measurements': [{'value': '96.0', 'groupId': 'OG000', 'lowerLimit': '93.3', 'upperLimit': '98.7'}]}]}, {'title': '1080 Days Post Implant', 'categories': [{'measurements': [{'value': '94.0', 'groupId': 'OG000', 'lowerLimit': '90.6', 'upperLimit': '97.3'}]}]}, {'title': '1440 Days Post Implant', 'categories': [{'measurements': [{'value': '91.4', 'groupId': 'OG000', 'lowerLimit': '87.2', 'upperLimit': '95.5'}]}]}, {'title': '1800 Days Post Implant', 'categories': [{'measurements': [{'value': '85.4', 'groupId': 'OG000', 'lowerLimit': '79.9', 'upperLimit': '90.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'K-M Estimate (%) for Freedom of appropriate shock therapy for VT/VF', 'unitOfMeasure': 'percentage of freedom of appr. shocks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Extension Phase Inappropriate Shock Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Phase Sub Study', 'description': 'Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry'}], 'classes': [{'title': '240 Days Post Implant', 'categories': [{'measurements': [{'value': '98.0', 'groupId': 'OG000', 'lowerLimit': '96.1', 'upperLimit': '99.9'}]}]}, {'title': '360 Days Post Implant', 'categories': [{'measurements': [{'value': '96.0', 'groupId': 'OG000', 'lowerLimit': '93.3', 'upperLimit': '98.7'}]}]}, {'title': '720 Days Post Implant', 'categories': [{'measurements': [{'value': '93.5', 'groupId': 'OG000', 'lowerLimit': '90.1', 'upperLimit': '96.9'}]}]}, {'title': '1080 Days Post Implant', 'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000', 'lowerLimit': '85.9', 'upperLimit': '94.2'}]}]}, {'title': '1440 Days Post Implant', 'categories': [{'measurements': [{'value': '89.0', 'groupId': 'OG000', 'lowerLimit': '84.6', 'upperLimit': '93.4'}]}]}, {'title': '1800 Days Post Implant', 'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000', 'lowerLimit': '83.2', 'upperLimit': '92.7'}]}]}, {'title': '2160 Days Post Implant', 'categories': [{'measurements': [{'value': '86.2', 'groupId': 'OG000', 'lowerLimit': '80.9', 'upperLimit': '91.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'K-M Estimate (%) for Freedom of Inappropriate Shock Therapy', 'unitOfMeasure': '% of freedom of inappropriate shocks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Extension Phase VF Induction Testing at Replacement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ext. Phase Subjects for Whom VF Induction Testing Was Performed During the Replacement Procedures', 'description': 'Subjects participating in the Extension Phase for whom VF induction testing was performed during the replacement procedures (N=33)'}], 'classes': [{'title': 'Subjects with at least one evaluable conversion test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'At least one Successful Conversion <= 65J', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}, {'title': 'Successful Conversions > 65J only', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Subjects with Successful Shock Energy NOT Documented', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'All Conversions have Incomplete Data', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Subjects with only non-evaluable conversion tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'title': 'At least one Successful Conversion <= 65J', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Successful Conversions > 65J only', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Subjects with Successful Shock Energy NOT Documented', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'All Conversions have Incomplete Data', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'Percentage of VF induction testing at replacement', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects participating in the Extension Phase for whom which VF induction testing was performed during the replacement procedures (N=33)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Extension Phase Additional Invasive Interventions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Phase Sub Study', 'description': 'Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry'}], 'classes': [{'title': 'PG Revision', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Electrode Revision', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Major Cardiac Surgery Revision', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Other, incl. blood draw, IV Rx, angio, cardioversion, PCI, ablation', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'Number of Additional invasive interventions', 'unitOfMeasure': 'Number of Interventions', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Extension Phase Additional Invasive Interventions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Phase Sub Study', 'description': 'Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry'}], 'classes': [{'title': 'PG Revision', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Electrode Revision', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Major Cardiac Surgery Revision', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Other, incl. blood draw, IV Rx, angio, cardioversion, PCI, ablation', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'Number of subjects with additional invasive interventions', 'unitOfMeasure': 'participants w. add. inv. intervention', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Extension Phase Use of Anti-arrhythmic Drugs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Phase Sub Study', 'description': 'Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry'}], 'classes': [{'title': 'Class I - Sodium Channel Blockers: Disopyramide', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Class I - Sodium Channel Blockers: Flecainide', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Class I - Sodium Channel Blockers: Mexiletine', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Class I - Sodium Channel Blockers: Quinidine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Class II - Beta Blockers: Atenolol', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Class II - Beta Blockers: Bisoprolol', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}]}]}, {'title': 'Class II - Beta Blockers: Carvedilol', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Class II - Beta Blockers: Celiprolol', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Class II - Beta Blockers: Metoprolol', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Class II - Beta Blockers: Nadolol', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Class II - Beta Blockers: Nebivolol', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Class II - Beta Blockers: Propranolol', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Class III - Potassium Channel Blockers: Amiodarone', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Class III - Potassium Channel Blockers: Sotalol', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Class IV - Calcium Channel Blockers: Amlodipine', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Class IV - Calcium Channel Blockers: Diltiazem', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Class IV - Calcium Channel Blockers: Felodipine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Class IV - Calcium Channel Blockers: Verapamil', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'Number of subjects in the Extension Phase using anti-arrhythmic drugs', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Extension Phase Ventricular Rate of Episodes (Mean)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}, {'units': 'episodes', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Phase Sub Study', 'description': 'Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry'}], 'classes': [{'title': 'Rate of observed discrete MVT Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}, {'units': 'episodes', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '217.5', 'spread': '33.3', 'groupId': 'OG000'}]}]}, {'title': 'Rate of observed discrete PVT/VF Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}, {'units': 'episodes', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '269.6', 'spread': '51.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'Ventricular rate in of episodes in beats per minute', 'unitOfMeasure': 'episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'episodes', 'denomUnitsSelected': 'episodes', 'populationDescription': 'All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Extension Phase Ventricular Rate of Episodes (Median)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}, {'units': 'episodes', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Phase Sub Study', 'description': 'Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry'}], 'classes': [{'title': 'Rate of observed discrete MVT Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}, {'units': 'episodes', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '210', 'groupId': 'OG000', 'lowerLimit': '120', 'upperLimit': '320'}]}]}, {'title': 'Rate of observed discrete PVT/VF Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}, {'units': 'episodes', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '260', 'groupId': 'OG000', 'lowerLimit': '200', 'upperLimit': '400'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'Ventricular rate in of episodes in beats per minute', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'episodes', 'denomUnitsSelected': 'episodes', 'populationDescription': 'All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Extension Phase Ventricular Rate of Episodes (IQR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}, {'units': 'episodes', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Phase Sub Study', 'description': 'Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry'}], 'classes': [{'title': 'Rate of observed discrete MVT Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}, {'units': 'episodes', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '217.5', 'groupId': 'OG000', 'lowerLimit': '200', 'upperLimit': '240'}]}]}, {'title': 'Rate of observed discrete PVT/VF Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}, {'units': 'episodes', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '269.6', 'groupId': 'OG000', 'lowerLimit': '240', 'upperLimit': '300'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'Ventricular rate in of episodes in beats per minute', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'episodes', 'denomUnitsSelected': 'episodes', 'populationDescription': 'All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Extension Phase Ventricular Rate of Non-Sustained Episodes (Mean)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}, {'units': 'episodes', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Phase Sub Study', 'description': 'Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry'}], 'classes': [{'title': 'Rate of observed Non-Sustained MVT Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}, {'units': 'episodes', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '212.3', 'spread': '25.8', 'groupId': 'OG000'}]}]}, {'title': 'Rate of observed Non-Sustained PVT/VF Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}, {'units': 'episodes', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '248.4', 'spread': '60.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'Ventricular rate in of episodes in beats per minute', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'episodes', 'denomUnitsSelected': 'episodes', 'populationDescription': 'All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Extension Phase Ventricular Rate of Non-Sustained Episodes (Median)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}, {'units': 'episodes', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Phase Sub Study', 'description': 'Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry'}], 'classes': [{'title': 'Rate of observed Non-Sustained MVT Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}, {'units': 'episodes', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000', 'lowerLimit': '180', 'upperLimit': '300'}]}]}, {'title': 'Rate of observed Non-Sustained PVT/VF Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}, {'units': 'episodes', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000', 'lowerLimit': '184', 'upperLimit': '400'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'Ventricular rate in of episodes in beats per minute', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'episodes', 'denomUnitsSelected': 'episodes', 'populationDescription': 'All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Extension Phase Ventricular Rate of Non-Sustained Episodes (IQR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}, {'units': 'episodes', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Phase Sub Study', 'description': 'Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry'}], 'classes': [{'title': 'Rate of observed Non-Sustained MVT Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}, {'units': 'episodes', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '212.3', 'groupId': 'OG000', 'lowerLimit': '200', 'upperLimit': '220'}]}]}, {'title': 'Rate of observed Non-Sustained PVT/VF Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}, {'units': 'episodes', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '248.4', 'groupId': 'OG000', 'lowerLimit': '210', 'upperLimit': '260'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'Ventricular rate in of episodes in beats per minute', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'episodes', 'denomUnitsSelected': 'episodes', 'populationDescription': 'All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Complication Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}, {'units': 'events', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Phase Sub Study', 'description': 'Subset of Subjects, who had already completed the EFFORTLESS S-ICD Registry'}], 'classes': [{'categories': [{'title': 'Abnormal Thyroid Condition', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Adverse Reaction (Medications) (Non-System/Non-Procedure related)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Adverse Reaction (Respiratory)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Anemia', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Atrial Fibrillation/Flutter (Cardiac)', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Cancer', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Cardiac Arrest', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Chest Pain (Cardiac)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Coronary Artery Disease', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Death (as stand-alone event)', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Electrode Movement', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Erosion', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Fracture/Broken Bone', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'GI Disorder', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'HEENT Disorder', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Heart Failure/Worsening of Heart Failure', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Hematoma not related to TV-ICD Placement', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Hematoma related to TV-ICD Placement', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Inappropriate Shock: Cardiac Oversensing', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Inappropriate Shock: Non-Cardiac Oversensing', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Inappropriate Shock: SVT Above Discrimination Zone (Normal Device Function)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Infection not related to S-ICD System', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Inflammation (Non-Cardiac/Non-System/Non-Procedure related)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Multi-system Failure', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Other (Non-Cardiac/Non-System/Non-Procedure related)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Other: Cardiac (Non-System/Procedure related)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Pain/Discomfort (Non-Cardiac/Non-System/Non-Procedure related)', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Peripheral Vascular Disease', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Pneumonia', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Premature Cell Battery Depletion: Premature Declaration', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Premature Cell Battery Depletion: Random Component Failure', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Respiratory Failure (Non-Cardiac/Non-System/Non-Procedure related)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Shortness of Breath, Dyspnea (Non-Cardiac/Non-System/Non-Procedure related)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Skeletal/ Muscular Injury', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Syncope (Non-Cardiac/Non-System/Non-Procedure related)', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'System Infection', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Unable to Convert: During Procedure', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Worsening of Benign Prostatic Hyperplasia', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Worsening of VT/VF', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'From enrollment in the initial main study until the 5th annual follow-up of the substudy.', 'description': 'Summary of all reported complications defined as a clinical event that results in invasive intervention.', 'calculatePct': False, 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'events', 'denomUnitsSelected': 'events', 'populationDescription': 'All subjects enrolled in the EFFORTLESS Extension Phase Sub Study (N=203)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'EFFORTLESS Main Study', 'description': "Patients implanted with a CE marked S-ICD System, not participating in Cameron Health's Investigational Device Exemption (IDE) Clinical Study.\n\nS-ICD System: The S-ICD System is an implantable technology that uses a subcutaneous pulse generator and subcutaneous electrode system to treat ventricular tachyarrhythmias. The S-ICD System consists of the pulse generator, subcutaneous electrode, the programmer and electrode insertion tool."}], 'periods': [{'title': 'Main Study', 'milestones': [{'type': 'STARTED', 'comment': 'signed consent', 'achievements': [{'groupId': 'FG000', 'numSubjects': '994'}]}, {'type': 'Baseline', 'comment': 'implanted \\& followed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '984'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '703'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '291'}]}]}, {'title': 'EFFORTLESS Extension Phase Substudy', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '203'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '164'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '984', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'EFFORTLESS Main Study', 'description': "Patients implanted with a CE marked S-ICD System, not participating in Cameron Health's Investigational Device Exemption (IDE) Clinical Study.\n\nS-ICD System: The S-ICD System is an implantable technology that uses a subcutaneous pulse generator and subcutaneous electrode system to treat ventricular tachyarrhythmias. The S-ICD System consists of the pulse generator, subcutaneous electrode, the programmer and electrode insertion tool."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '984', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '48.4', 'spread': '16.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '984', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '275', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '709', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': "Patients implanted with a CE marked S-ICD System, not participating in Cameron Health's Investigational Device Exemption (IDE) Clinical Study.\n\nS-ICD System: The S-ICD System is an implantable technology that uses a subcutaneous pulse generator and subcutaneous electrode system to treat ventricular tachyarrhythmias. The S-ICD System consists of the pulse generator, subcutaneous electrode, the programmer and electrode insertion tool.\n\nMain Study"}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-04', 'size': 7619811, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-04-06T06:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 994}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-30', 'studyFirstSubmitDate': '2010-03-10', 'resultsFirstSubmitDate': '2022-04-14', 'studyFirstSubmitQcDate': '2010-03-10', 'lastUpdatePostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-19', 'studyFirstPostDateStruct': {'date': '2010-03-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Extension Phase Rate of Long-term S-ICD System-related Adverse Events', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'Rate of adverse events related to the S-ICD system in subjects of the EFFORTLESS Extension Phase sub study'}, {'measure': 'Extension Phase S-ICD Replacements for Functionality', 'timeFrame': 'From enrollment into the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'Number of S-ICD replacements with another type of implantable defibrillator for functionality unavailable with an S-ICD, such as a need for additional brady therapy, cardiac resynchronization therapy, antitachycardia pacing, or other similar reasons'}, {'measure': 'Extension Phase Device Longevity', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'Minimum Implant Time (Days). The data includes information on devices tracked from the date of implant until they went out of service, as well as devices tracked from implant until the last available follow-up before the subject exited the study for any reason (such as study conclusion, death, or withdrawal). Devices still functioning at the end of their observation period continue to add to their longevity beyond this period. Thus, the reported value underestimates actual device longevity, representing only the minimum duration these devices were known to function.'}, {'measure': 'Extension Phase Rate of Complications Related to the S-ICD Replacements', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'K-M Estimate (%) for freedom of complications related to the S-ICD replacements'}, {'measure': 'Extension Phase Appropriate Shock Therapy for VT/VF', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'K-M Estimate (%) for Freedom of appropriate shock therapy for VT/VF'}, {'measure': 'Extension Phase Inappropriate Shock Therapy', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'K-M Estimate (%) for Freedom of Inappropriate Shock Therapy'}, {'measure': 'Extension Phase VF Induction Testing at Replacement', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'Percentage of VF induction testing at replacement'}, {'measure': 'Extension Phase Additional Invasive Interventions', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'Number of Additional invasive interventions'}, {'measure': 'Extension Phase Additional Invasive Interventions', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'Number of subjects with additional invasive interventions'}, {'measure': 'Extension Phase Use of Anti-arrhythmic Drugs', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'Number of subjects in the Extension Phase using anti-arrhythmic drugs'}, {'measure': 'Extension Phase Ventricular Rate of Episodes (Mean)', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'Ventricular rate in of episodes in beats per minute'}, {'measure': 'Extension Phase Ventricular Rate of Episodes (Median)', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'Ventricular rate in of episodes in beats per minute'}, {'measure': 'Extension Phase Ventricular Rate of Episodes (IQR)', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'Ventricular rate in of episodes in beats per minute'}, {'measure': 'Extension Phase Ventricular Rate of Non-Sustained Episodes (Mean)', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'Ventricular rate in of episodes in beats per minute'}, {'measure': 'Extension Phase Ventricular Rate of Non-Sustained Episodes (Median)', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'Ventricular rate in of episodes in beats per minute'}, {'measure': 'Extension Phase Ventricular Rate of Non-Sustained Episodes (IQR)', 'timeFrame': 'From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.', 'description': 'Ventricular rate in of episodes in beats per minute'}, {'measure': 'Complication Events', 'timeFrame': 'From enrollment in the initial main study until the 5th annual follow-up of the substudy.', 'description': 'Summary of all reported complications defined as a clinical event that results in invasive intervention.'}], 'primaryOutcomes': [{'measure': 'Perioperative S-ICD Complication Free Rate', 'timeFrame': '30 days post implant', 'description': 'The number of subjects without Type I Complications within 30 Days of Implant divided by the Total Implanted Subjects.'}, {'measure': '360 Day S-ICD Complication Free Rate', 'timeFrame': 'Minimum 360 days post implant', 'description': 'The Kaplan-Meier (KM) Survival Estimate of 360-Day Type I Complications.'}, {'measure': 'Percentage of Inappropriate Shocks for Atrial Fibrillation (AF)/Supraventricular Tachycardia (SVT)', 'timeFrame': 'From enrollment to 5-year annual visit.', 'description': 'The number of subjects who received at least one inappropriate shock for SVT above the discrimination zone and SVT discriminator errors divided by the total implanted subjects.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['ICD', 'defibrillator'], 'conditions': ['Tachycardia, Ventricular']}, 'referencesModule': {'references': [{'pmid': '28797351', 'type': 'DERIVED', 'citation': 'Boersma L, Barr C, Knops R, Theuns D, Eckardt L, Neuzil P, Scholten M, Hood M, Kuschyk J, Jones P, Duffy E, Husby M, Stein K, Lambiase PD; EFFORTLESS Investigator Group. Implant and Midterm Outcomes of the Subcutaneous Implantable Cardioverter-Defibrillator Registry: The EFFORTLESS Study. J Am Coll Cardiol. 2017 Aug 15;70(7):830-841. doi: 10.1016/j.jacc.2017.06.040.'}, {'pmid': '25908064', 'type': 'DERIVED', 'citation': 'Burke MC, Gold MR, Knight BP, Barr CS, Theuns DAMJ, Boersma LVA, Knops RE, Weiss R, Leon AR, Herre JM, Husby M, Stein KM, Lambiase PD. Safety and Efficacy of the Totally Subcutaneous Implantable Defibrillator: 2-Year Results From a Pooled Analysis of the IDE Study and EFFORTLESS Registry. J Am Coll Cardiol. 2015 Apr 28;65(16):1605-1615. doi: 10.1016/j.jacc.2015.02.047.'}, {'pmid': '24670710', 'type': 'DERIVED', 'citation': 'Lambiase PD, Barr C, Theuns DA, Knops R, Neuzil P, Johansen JB, Hood M, Pedersen S, Kaab S, Murgatroyd F, Reeve HL, Carter N, Boersma L; EFFORTLESS Investigators. Worldwide experience with a totally subcutaneous implantable defibrillator: early results from the EFFORTLESS S-ICD Registry. Eur Heart J. 2014 Jul 1;35(25):1657-65. doi: 10.1093/eurheartj/ehu112. Epub 2014 Mar 26.'}]}, 'descriptionModule': {'briefSummary': 'The EFFORTLESS ICD Registry is an observational, standard of care evaluation designed to demonstrate the early, mid and long-term clinical effectiveness the Boston Scientific S-ICD System. In addition, analysis of resource utilization and costs will be performed to document treatment costs for periods defined by Registry endpoints. Protocol 90904928 restricts enrolment to patients over 18 years of age while protocol 90904925 allows all patients to be included.', 'detailedDescription': "EFFORTLESS is an observational, post market, standard of care, Registry to be conducted at approximately 50 centers worldwide in patients requiring an ICD for the treatment of ventricular tachyarrhythmias. Patients included in the registry will have been implanted with the S-ICD system since its CE mark (commercial regulatory approval) and will be followed for up to 60 months. The patients' perception of their therapy will be evaluated using Quality of Life assessments and the Registry will include an exploratory analysis of resource utilization and costs based on measures of clinical outcome such as complication rates, unscheduled hospitalizations and length of stay. The objective will be to enable comparison of costs of the S-ICD system versus a standard transvenous system.\n\nAn Extension Phase Sub-Study will extend the EFFORTLESS S-ICD Registry in order to achieve an average of approximately 8 years of follow-up from index procedure. A subgroup of approximately 200 patients will be enrolled at a sub-set of EFFORTLESS sites. The data analysis will focus on long-term S-ICD system-related adverse events, S-ICD replacements and device longevity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Post CE mark ICD patients eligible for implantation of the S-ICD system', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main study:\n\nInclusion Criteria\n\n1. Age \\>/= 18yrs\n2. Eligible for implantation of an S-ICD system per local clinical guidelines or currently implanted with an S-ICD system (Software (SW) version 1.59.0 or later)\n3. Willing and able to provide written informed consent or have informed consent as provided by a legal representative\n\nExclusion Criteria:\n\n1. Participation in any other investigational study that may interfere with interpretation of the Registry results\n2. Incessant ventricular tachycardia and/or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing\n3. Patients with unipolar pacemakers or implanted devices that revert to unipolar pacing\n\nExtension Phase Sub-study:\n\nInclusion Criteria\n\n1. Subjects who are actively enrolled in the EFFORTLESS S-ICD Registry OR Subjects who completed the 5-year follow-up in the EFFORTLESS S-ICD Registry. All clinical events, spontaneous and induced episode data and system replacement or revision data since the last EFFORTLESS S-ICD Annual Follow-Up of the main study must be available in medical files or equivalent.\n2. Subjects who are actively implanted with an S-ICD pulse generator (SQ-RX, EMBLEM or EMBLEM MRI) and an S-ICD electrode (Q-TRAK or EMBLEM) or any other future commercial available versions\n3. Willing and able to provide written informed consent or have informed consent as provided by a legal representative and willing to participate in all testing and follow-ups as described the Sub-Study protocol\n4. Age 18 or above, and of legal age to give informed consent specific to national laws\n\nExclusion Criteria\n\n1. Subjects with device replacement from the S-ICD to a transvenous ICD\n2. Subjects with unipolar pacemakers or implanted devices that revert to unipolar pacing\n3. Subjects that are participating in any other investigational study that may interfere with interpretation of the Registry results, without the written approval of Boston Scientific'}, 'identificationModule': {'nctId': 'NCT01085435', 'acronym': 'EFFORTLESS', 'briefTitle': 'Boston Scientific Post Market Subcutaneous-Implantable Cardioverter Defibrillator (S-ICD) Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Evaluation oF Factors ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD (The EFFORTLESS S-ICD Registry)', 'orgStudyIdInfo': {'id': '90904925; 90904928'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EFFORTLESS Main Study', 'description': "Patients implanted with a CE marked S-ICD System, not participating in Cameron Health's Investigational Device Exemption (IDE) Clinical Study.", 'interventionNames': ['Device: S-ICD System']}, {'label': 'Extension Phase Sub Study', 'description': 'The Sub-Study patients were preferably recruited from the active EFFORTLESS S-ICD patient population. Patients, who had already completed the EFFORTLESS S-ICD Registry in the past, were considered secondarily for participation in the Sub-Study.', 'interventionNames': ['Device: S-ICD System']}], 'interventions': [{'name': 'S-ICD System', 'type': 'DEVICE', 'otherNames': ['S-ICD Pulse Generator', 'S-ICD Subcutaneous Electrode', 'S-ICD Electrode Insertion Tool', 'S-ICD Programmer'], 'description': 'The S-ICD System is an implantable technology that uses a subcutaneous pulse generator and subcutaneous electrode system to treat ventricular tachyarrhythmias. The S-ICD System consists of the pulse generator, subcutaneous electrode, the programmer and electrode insertion tool.', 'armGroupLabels': ['EFFORTLESS Main Study', 'Extension Phase Sub Study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15030', 'city': 'Prague', 'state': 'Prague 5', 'country': 'Czechia', 'facility': 'Na Homolce Hospital', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '2100', 'city': 'Copenhagen', 'state': 'København', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'city': 'Marseille', 'country': 'France', 'facility': 'CHU La Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Nantes', 'country': 'France', 'facility': 'Nouvelles Cliniques Nantaises', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Pessac', 'country': 'France', 'facility': "Hôpital Cardiologique du Haut-L'évêque", 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'city': 'Bad Krozingen', 'country': 'Germany', 'facility': 'Universitäts-Herzzentrum Freiburg-Bad Krozingen', 'geoPoint': {'lat': 47.91667, 'lon': 7.7}}, {'city': 'Bernau', 'country': 'Germany', 'facility': 'Immanuel Klinikum Bernau Herzzentrum Brandenburg', 'geoPoint': {'lat': 47.80018, 'lon': 8.0383}}, {'city': 'Bielefeld', 'country': 'Germany', 'facility': 'Klinikum Bielefeld', 'geoPoint': {'lat': 52.03333, 'lon': 8.53333}}, {'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Lübeck', 'country': 'Germany', 'facility': 'University Hospital Schleswig-Holstein', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'city': 'Mannheim', 'country': 'Germany', 'facility': 'Universitätsmedizin Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '81377', 'city': 'Munich', 'country': 'Germany', 'facility': 'Ludwig-Maximilians-Universität München, Campus Großhadern', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'city': 'Münster', 'country': 'Germany', 'facility': 'Universitätsklinikum Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Papenburg', 'country': 'Germany', 'facility': 'Marienkrankenhaus Papenburg', 'geoPoint': {'lat': 53.07769, 'lon': 7.41516}}, {'city': 'Catania', 'country': 'Italy', 'facility': 'Arnas Garibaldi Nesima', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Negrar', 'country': 'Italy', 'facility': 'Ospedale Sacro Cuore Don Calabria', 'geoPoint': {'lat': 45.52918, 'lon': 10.93899}}, {'city': 'Padua', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Pisa', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Pisana', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'Policlinico Casilino', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '6202', 'city': 'Maastricht', 'state': 'AZ Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '5623', 'city': 'Eindhoven', 'state': 'EJ Eindhoven', 'country': 'Netherlands', 'facility': 'Catharina Eindhoven Hospital', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Amsterdam Medisch Centrum', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '7513 ER', 'city': 'Enschede', 'country': 'Netherlands', 'facility': 'Medisch Spectrum Twente', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}, {'zip': '9713', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '3430 EM', 'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'St Antonius Ziekenhuis', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'zip': '3000 CA', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '1142', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland City Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'city': 'Carnaxide', 'country': 'Portugal', 'facility': 'Hospital Santa Cruz', 'geoPoint': {'lat': 38.72706, 'lon': -9.24671}}, {'city': 'A Coruña', 'country': 'Spain', 'facility': 'Complexo Hospitalario Universitario', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': 'CB23 3RE', 'city': 'Cambridge', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': 'Papworth Hospital', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'LS1 1YY', 'city': 'Leeds', 'state': 'Yorkshire', 'country': 'United Kingdom', 'facility': 'Leeds General Infirmary', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'BN2 5BE', 'city': 'Brighton', 'country': 'United Kingdom', 'facility': 'Royal Sussex County Hospital', 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}, {'zip': 'BS2 8HW', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Bristol Royal Infirmary', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'DY1 2HQ', 'city': 'Dudley', 'country': 'United Kingdom', 'facility': 'Russells Hall Hospital', 'geoPoint': {'lat': 52.5, 'lon': -2.08333}}, {'zip': 'G3 8SJ', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': "Yorkhill Children's Hospital", 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Yorkshire Heart Centre', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'W1G 8SE', 'city': 'London', 'country': 'United Kingdom', 'facility': "St. Bartholomew's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Kings College Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'OX3 9DU', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'John Radcliffe Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Northern General Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'Southampton General', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'overallOfficials': [{'name': 'Pier Lambiase, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': "St. Bartholomew's Hospital, London"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}