Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2026-03-03 @ 10:05 AM
Study NCT ID:
NCT01736618
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2012-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
S-ICD® System Post Approval Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jill.leigh@bsci.com', 'phone': '1-800-227-3422', 'title': 'Clinical Trial Manager or Director of Clinical Trials (Cardiology Rhythm Management)', 'organization': 'Boston Scientific - Rhythm Management'}, 'certainAgreement': {'otherDetails': 'PI shall submit publication to Sponsor for review at least 60 days prior to submission. Sponsor reserves the right to delete any confidential info or other proprietary info of Sponsor (not incl. Results). Sponsor may extend 90 days to protect its intellectual property (IP) interests. PI shall be free to publish the results of the study after: Initial Publication is published; notification by Sponsor that Initial Publication is no longer planned; or 12 mo. after the expiration date at all sites', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Data was collected over a 60 month (5-year) follow-up period', 'eventGroups': [{'id': 'EG000', 'title': 'S-ICD System Implant Attempt', 'description': 'All subjects undergo an S-ICD System implant procedure.', 'otherNumAtRisk': 1766, 'deathsNumAtRisk': 1766, 'otherNumAffected': 247, 'seriousNumAtRisk': 1766, 'deathsNumAffected': 294, 'seriousNumAffected': 638}], 'otherEvents': [{'term': 'Inappropriate Shock - Inappropriate Sensing: Cardiac Oversensing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 134, 'numAffected': 109}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inappropriate Shock - Inappropriate Sensing: Extra-cardiac Oversensing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 47, 'numAffected': 46}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Discomfort - Post-op > 30-Days - Device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Incisional/Superficial Infection - Procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma <= 30 days post-implant - Procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Discomfort - Post-op ≤ 30-Days - Procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Heart Failure (HF)/ Worsening HF', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 68, 'numAffected': 63}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening VT/VF', 'notes': 'Worsening Ventricular Tachycardia/Ventricular Fibrillation - Cardiovascular related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 55, 'numAffected': 50}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain - Cardiovascular related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 26, 'numAffected': 25}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Fibrillation / Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 24, 'numAffected': 23}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia/ AV Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulseless Electrical Activity (PEA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiogenic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other -Cardiovascular related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Premature Ventricular Contractions (PVC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Supraventricular Tachycardia (SVT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aortic Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inflammation - Cardiovascular related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Multisystem Failure - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 53, 'numAffected': 53}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death - unknown cause', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 38, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope - Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Near Syncope/Dizziness/Shortness of Breath/Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope - Non-cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain - Non-cardiac other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal Laboratory Values', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Multiple Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Near Syncope/Dizziness/Shortness of Breath/Confusion', 'notes': 'Non-Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other - Patient Condition - Non-cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection - Non-device/procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 51, 'numAffected': 49}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection - S-ICD System/Implant Procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 45, 'numAffected': 45}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma <= 30 days post-implant - Procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection - Incisional/Superficial Infection - Procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse Reaction - Hypotension - Procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Discomfort - Post-op > 30-Days - Device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sub-optimal Electrode Position - Procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse Reaction to Medications - Procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elective Device Replacement', 'notes': 'Replacement of the S-ICD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Electrode Movement - Procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inadequate healing of incision site - Procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Trauma - Other', 'notes': 'Non-device system related trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac arrest - Procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Electrode movement - Electrode related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Failure - Procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse Reaction Respiratory - Procedure Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding - Procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever - Procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart Failure / Worsening of Heart Failure - Procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma - Pocket (> 30 days post-implant)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma > 30 days post-implant - Procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PG movement / Revision - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural Effusion - Procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumothorax - Procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulseless Electrical Activity (PEA) Post Anesthesia prior to Implant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seroma - Procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sub-optimal device and electrode position - Procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inappropriate Shock - Inappropriate Sensing: Cardiac Oversensing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 64, 'numAffected': 57}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inappropriate Shock - Inappropriate Sensing: Extra-cardiac Oversensing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inappropriate Shock - Above Programmed Rate Zone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Premature Cell Battery Depletion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inappropriate Shock - Inappropriate Sensing: Discrimination Error', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unable to Convert - During Device System Implant Procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erosion - Device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Appropriate Shock - Accelerated Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': "Electrode Conductor Fracture- Presumed Twiddler's Syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erosion - Electrode related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erosion - Imminent Erosion - Device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inability to Communicate with the Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inappropriate Shock - Inappropriate Sensing: Baseline Shift', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Trauma to Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unable to Convert - During Device Testing Procedure >150 days - Patient condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Undersensing - Device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychological Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shortness of Breath/Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 30, 'numAffected': 29}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke - Procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral Vascular Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient Ischemic Attack (TIA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Discomfort - Post-op ≤ 30-Days - Procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Discomfort - Post-op ≤ 30-Days - Device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Device Movement - Revision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1766, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Free From Type I Complication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1964', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'S-ICD System Implant Attempt', 'description': 'All subjects undergo an S-ICD System implant procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '1869', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Kaplan-Meier', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '92.9', 'ciLowerLimit': '91.4', 'groupDescription': 'Ho: The Type I Complication Free Rate at 60 months (p1) does not exceed the performance goal of 85.0%.\n\nHo: p1 ≤ 85.0% Ha: The Type I Complication Free Rate at 60 months (p1) does exceed the performance goal of 85.0%.\n\nHa: p1 \\> 85.0% The null hypothesis will be rejected if the lower one-sided 95% confidence bound of the proportional means model estimate, using the Peto method for standard error, exceeds the performance goal of 85.0%.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 months (1800 days)', 'description': 'Type I complications are adverse events caused by a component of the S-ICD System (i.e. pulse generator, electrode, EIT or programmer) that results in permanent loss of device function, invasive intervention or death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'S-ICD PAS enrolled de novo implant subjects as well as prior IDE participants. Primary Safety endpoint includes subjects enrolled in S-ICD PAS combined with the subjects from the S-ICD IDE (NCT# 01064076). S-ICD PAS had 1643 de novo implant attempts and 123 prior IDE implant subjects, for endpoint analyses this was combined with the data from the 198 IDE implant attempt subjects that did not participate in S-ICD PAS, totaling 1964 subjects.'}, {'type': 'PRIMARY', 'title': 'Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1951', 'groupId': 'OG000'}]}, {'units': 'S-ICD Shocks', 'counts': [{'value': '512', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'S-ICD System Implant Attempt', 'description': 'All subjects undergo an S-ICD System implant procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '505', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Clopper-Pearson exact confidence bound', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '98.6', 'ciLowerLimit': '97.4', 'groupDescription': 'Ho: Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF through 60 months (p1) does not exceed the performance goal of 94.0%.\n\nHo: p1 ≤ 94.0% Ha: Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF through 60 months (p1) does exceed the performance goal of 94.0%.\n\nHa: p1 \\>94.0% The null hypothesis will be rejected if the lower one-sided 95% exact confidence bound of the estimate exceeds the performance goal of 94.0%.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '60 months (1825 days)', 'description': 'Overall shock effectiveness refers to conversion of an episode following on any of the 5 shocks (maximum) that may be delivered during a single episode. Discrete episodes of VT/VF are those that are temporally independent (\\<3 within a 24 hour period), unlike storm episodes, which occur in clusters (≥3 episodes within a 24 hour period). Episodes that spontaneously terminate will be excluded from this endpoint since the effectiveness of the shock cannot be evaluated in such circumstances.', 'unitOfMeasure': 'S-ICD Shocks', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'S-ICD Shocks', 'denomUnitsSelected': 'S-ICD Shocks', 'populationDescription': 'Primary effectiveness endpoint includes subjects in S-ICD PAS combined with the subjects from the S-ICD IDE (NCT# 01064076). S-ICD PAS had 1637 de novo implants and 123 prior IDE implant subjects, for endpoint analyses this was combined with the data from the 191 IDE implanted subjects that did not participate in S-ICD PAS, totaling 1951 subjects. This endpoint analyzes all appropriate shocks.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Free From Electrode-related Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1964', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'S-ICD System Implant Attempt', 'description': 'All subjects undergo an S-ICD System implant procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '1953', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Kaplan-Meier', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '99.2', 'ciLowerLimit': '98.8', 'groupDescription': 'Ho: The Electrode-Related Complication Free Rate at 60 months (p1) does not exceed the performance goal of 92.5%.\n\nHo: p1 ≤ 92.5% Ha: The Electrode-Related Complication Free Rate at 60 months (p1) does exceed the performance goal of 92.5%.\n\nHa: p1 \\> 92.5% The null hypothesis will be rejected if the lower one-sided 95% confidence bound of the proportional means model estimate, using the Peto method for standard error, exceeds the performance goal of 92.5%.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 months (1800 days)', 'description': 'The electrode related complications analyzed for this end-point include: complications occurring less than or equal to 30 days post implant that are attributable to structural electrode failure for electrode movement, electrode impendence out of range, electrode conductor fracture, deformation or breakage or insulation failure; OR occurring greater than 30 days post implant regardless of structural failure for electrode movement, electrode impendence out of range, electrode conductor fracture, deformation/breakage or insulation failure; OR occurring greater than 30 days post implant attributable to structural electrode failure for incomplete/improper header connection, in-subject damage to electrode, electrode revision to optimize therapy, electrode movement, infection, oversensing/undersensing. Additionally, a complication is an adverse event that results in permanent loss of device function, invasive intervention or death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Secondary safety endpoint includes subjects in S-ICD PAS combined with the subjects from the S-ICD IDE (NCT# 01064076). S-ICD PAS had 1643 de novo implant attempts and 123 prior IDE implant subjects, for endpoint analyses this was combined with the data from the 198 IDE implant attempt subjects that did not participate in S-ICD PAS, totaling 1964 subjects.'}, {'type': 'SECONDARY', 'title': 'First Shock Effectiveness in Converting Induced (Acute) and Spontaneous Discrete Episodes of VT/VF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1951', 'groupId': 'OG000'}]}, {'units': 'S-ICD Shocks', 'counts': [{'value': '2195', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'S-ICD System Implant Attempt', 'description': 'All subjects undergo an S-ICD System implant procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '2071', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Clopper-Pearson exact confidence bound', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '94.4', 'ciLowerLimit': '93.5', 'groupDescription': 'Ho: The 1st Shock Effectiveness in Converting Induced (Acute) \\& Spontaneous Discrete VT/VF Episodes to 60 months (p1) does not exceed the performance goal of 84.0%.\n\nHo: p1 ≤ 84.0% Ha: The 1st Shock Effectiveness in Converting Induced (Acute) \\& Spontaneous Discrete VT/VF Episodes to 60 months (p1) does exceed the performance goal of 84.0%.\n\nHa: p1 \\>84.0% The null hypothesis will be rejected if lower one-sided 95% exact confidence bound of the estimate exceeds the performance goal of 84.0%.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '60 months (1825 days)', 'description': 'The rate in first shock effectiveness in converting induced (acute) and spontaneous discrete episodes of VT/VF through 60 months (1825 days) is calculated as the number of successful first shock conversions divided by the total evaluable episodes Acute Tests included: S-ICD PAS Study: Acute tests include induced episodes during the initial implant hospitalization after enrollment. Inductions may have been done on different days, but all occurred before the patient was discharged after initial implant; IDE Study : Acute tests included induced episodes occurring during the initial implant procedure as well as subsequent hospitalization until the final system position was obtained.\n\n* Acute Test Shock Energy Levels included all energy levels in the PAS Study and only 65 Joule shocks in the IDE Study.\n* Acute Test Arrhythmias included all VT and VF episodes for the PAS Study and only VF episodes for the IDE Study.', 'unitOfMeasure': 'S-ICD Shocks', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'S-ICD Shocks', 'denomUnitsSelected': 'S-ICD Shocks', 'populationDescription': 'The secondary effectiveness endpoint includes subjects in S-ICD PAS combined with the subjects from the S-ICD IDE (NCT# 01064076). S-ICD PAS had 1637 de novo implants and 123 prior IDE implant subjects, for endpoint analyses this was combined with the data from the 191 IDE implanted subjects that did not participate in S-ICD PAS, totaling 1951 subjects. This endpoint analyzes all induced (acute) or spontaneous appropriately treated discrete VT/VF shocks.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'S-ICD System Implant Attempt', 'description': 'All subjects undergo an S-ICD System implant procedure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1766'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '767'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '999'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '294'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '193'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '54'}]}, {'type': 'Subject unable to be followed at study location', 'reasons': [{'groupId': 'FG000', 'numSubjects': '223'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'Transplant or removal of target organ', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'Change in indication or condition', 'reasons': [{'groupId': 'FG000', 'numSubjects': '78'}]}, {'type': 'Study device explant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '103'}]}, {'type': 'Unable to complete implant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1766', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'S-ICD System Implant Attempt', 'description': 'All subjects undergo an S-ICD System implant procedure.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1766', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '53.2', 'spread': '15.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1766', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '542', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1224', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race and Ethnicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1766', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Caucasian', 'measurements': [{'value': '1048', 'groupId': 'BG000'}]}, {'title': 'Black, of African heritage', 'measurements': [{'value': '508', 'groupId': 'BG000'}]}, {'title': 'Hispanic or Latino', 'measurements': [{'value': '104', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Multi-racial', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Not Disclosed', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1766', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1766', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Device Indication', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1766', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Primary prevention', 'measurements': [{'value': '1359', 'groupId': 'BG000'}]}, {'title': 'Secondary prevention', 'measurements': [{'value': '407', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Left Ventricular Ejection Fraction', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1714', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '32.3', 'spread': '14.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '% of LV volume ejected per heart beat', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'EF was only available for 1714 participants.'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1762', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '29.9', 'spread': '7.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'BMI was only available for 1762 participants'}, {'title': 'History of Atrial Fibrillation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1760', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '732', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Atrial Fibrillation was only available for 1760 participants.'}, {'title': 'History of Hypertension', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1760', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1089', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Hypertension was only available for 1760 participants.'}, {'title': 'History of Diabetes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1760', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '592', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Diabetes history was only available for 1760 participants.'}, {'title': 'History of Myocardial Infarction', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1737', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '582', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'History of Myocardial Infarction was only available for 1737 participants.'}, {'title': 'History of Kidney Disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1760', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '432', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'History of Kidney Disease was only available for 1760 participants.'}, {'title': 'Creatinine Level', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1629', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '2.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Creatinine level was only available for 1629 participants.'}, {'title': 'History of Cancer', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1760', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'History of Cancer was only available for 1760 participants.'}, {'title': 'History of Coronary Artery Bypass Graft (CABG)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1752', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '284', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'History of CABG was only available for 1752 participants.'}, {'title': 'History of Percutaneous Revascularization', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1744', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '484', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'History of Percutaneous Revascularization was only available for 1744 participants.'}], 'populationDescription': 'All subjects who received an implant attempt are included.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2012-10-19', 'size': 1791268, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-07-13T09:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1766}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-22', 'studyFirstSubmitDate': '2012-11-27', 'resultsFirstSubmitDate': '2022-07-13', 'studyFirstSubmitQcDate': '2012-11-27', 'lastUpdatePostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-22', 'studyFirstPostDateStruct': {'date': '2012-11-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Free From Type I Complication', 'timeFrame': '60 months (1800 days)', 'description': 'Type I complications are adverse events caused by a component of the S-ICD System (i.e. pulse generator, electrode, EIT or programmer) that results in permanent loss of device function, invasive intervention or death.'}, {'measure': 'Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF', 'timeFrame': '60 months (1825 days)', 'description': 'Overall shock effectiveness refers to conversion of an episode following on any of the 5 shocks (maximum) that may be delivered during a single episode. Discrete episodes of VT/VF are those that are temporally independent (\\<3 within a 24 hour period), unlike storm episodes, which occur in clusters (≥3 episodes within a 24 hour period). Episodes that spontaneously terminate will be excluded from this endpoint since the effectiveness of the shock cannot be evaluated in such circumstances.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Free From Electrode-related Complications', 'timeFrame': '60 months (1800 days)', 'description': 'The electrode related complications analyzed for this end-point include: complications occurring less than or equal to 30 days post implant that are attributable to structural electrode failure for electrode movement, electrode impendence out of range, electrode conductor fracture, deformation or breakage or insulation failure; OR occurring greater than 30 days post implant regardless of structural failure for electrode movement, electrode impendence out of range, electrode conductor fracture, deformation/breakage or insulation failure; OR occurring greater than 30 days post implant attributable to structural electrode failure for incomplete/improper header connection, in-subject damage to electrode, electrode revision to optimize therapy, electrode movement, infection, oversensing/undersensing. Additionally, a complication is an adverse event that results in permanent loss of device function, invasive intervention or death.'}, {'measure': 'First Shock Effectiveness in Converting Induced (Acute) and Spontaneous Discrete Episodes of VT/VF', 'timeFrame': '60 months (1825 days)', 'description': 'The rate in first shock effectiveness in converting induced (acute) and spontaneous discrete episodes of VT/VF through 60 months (1825 days) is calculated as the number of successful first shock conversions divided by the total evaluable episodes Acute Tests included: S-ICD PAS Study: Acute tests include induced episodes during the initial implant hospitalization after enrollment. Inductions may have been done on different days, but all occurred before the patient was discharged after initial implant; IDE Study : Acute tests included induced episodes occurring during the initial implant procedure as well as subsequent hospitalization until the final system position was obtained.\n\n* Acute Test Shock Energy Levels included all energy levels in the PAS Study and only 65 Joule shocks in the IDE Study.\n* Acute Test Arrhythmias included all VT and VF episodes for the PAS Study and only VF episodes for the IDE Study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['subcutaneous implantable defibrillator, post approval study, sudden cardiac arrest, Cameron Health defibrillator'], 'conditions': ['Primary Prevention of Sudden Cardiac Arrest', 'Secondary Prevention of Sudden Cardiac Arrest']}, 'referencesModule': {'references': [{'pmid': '37676200', 'type': 'DERIVED', 'citation': 'Weiss R, Knight BP, El-Chami M, Aasbo J, Hanon S, Sadhu A, Sidhu M, Brisben AJ, Carter N, Burke MC, Gold M. Impact of Age on Subcutaneous Implantable Cardioverter-Defibrillator in a Large Patient Cohort: Mid-Term Follow-Up. JACC Clin Electrophysiol. 2023 Oct;9(10):2132-2145. doi: 10.1016/j.jacep.2023.06.013. Epub 2023 Sep 6.'}, {'pmid': '37495274', 'type': 'DERIVED', 'citation': 'Gold MR, El-Chami MF, Burke MC, Upadhyay GA, Niebauer MJ, Prutkin JM, Herre JM, Kutalek S, Dinerman JL, Knight BP, Leigh J, Lucas L, Carter N, Brisben AJ, Aasbo JD, Weiss R; S-ICD System Post Approval Study Investigators. Postapproval Study of a Subcutaneous Implantable Cardioverter-Defibrillator System. J Am Coll Cardiol. 2023 Aug 1;82(5):383-397. doi: 10.1016/j.jacc.2023.05.034.'}, {'pmid': '35944889', 'type': 'DERIVED', 'citation': 'Gold MR, Aasbo JD, Weiss R, Burke MC, Gleva MJ, Knight BP, Miller MA, Schuger CD, Carter N, Leigh J, Brisben AJ, El-Chami MF. Infection in patients with subcutaneous implantable cardioverter-defibrillator: Results of the S-ICD Post Approval Study. Heart Rhythm. 2022 Dec;19(12):1993-2001. doi: 10.1016/j.hrthm.2022.07.031. Epub 2022 Aug 6.'}, {'pmid': '33213814', 'type': 'DERIVED', 'citation': 'Burke MC, Aasbo JD, El-Chami MF, Weiss R, Dinerman J, Hanon S, Kalahasty G, Bass E, Gold MR. 1-Year Prospective Evaluation of Clinical Outcomes and Shocks: The Subcutaneous ICD Post Approval Study. JACC Clin Electrophysiol. 2020 Nov;6(12):1537-1550. doi: 10.1016/j.jacep.2020.05.036. Epub 2020 Aug 26.'}, {'pmid': '32376304', 'type': 'DERIVED', 'citation': 'El-Chami MF, Burke MC, Herre JM, Shah MH, Sadhu A, Niebauer MJ, Kutalek SP, Carter N, Gold MR. Outcomes of subcutaneous implantable cardioverter-defibrillator in dialysis patients: Results from the S-ICD post-approval study. Heart Rhythm. 2020 Sep;17(9):1566-1574. doi: 10.1016/j.hrthm.2020.04.036. Epub 2020 May 4.'}, {'pmid': '28502872', 'type': 'DERIVED', 'citation': 'Gold MR, Aasbo JD, El-Chami MF, Niebauer M, Herre J, Prutkin JM, Knight BP, Kutalek S, Hsu K, Weiss R, Bass E, Husby M, Stivland TM, Burke MC. Subcutaneous implantable cardioverter-defibrillator Post-Approval Study: Clinical characteristics and perioperative results. Heart Rhythm. 2017 Oct;14(10):1456-1463. doi: 10.1016/j.hrthm.2017.05.016. Epub 2017 May 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the S-ICD Post Approval Study is to document long term safety and effectiveness outcomes associated with the implantation of the SQ-RX pulse generator and Q-TRAK electrode in a commercial clinical setting.', 'detailedDescription': 'The S-ICD Post Approval Study is a non-randomized registry that will retrospectively enroll subjects who participated in the S-ICD Clinical Investigation (IDE G090013) and prospectively enroll new candidates for the S-ICD System. The target enrollment sample size is 1,616 subjects at up to 150 investigational sites to achieve 1,025 subjects in the analysis cohort at 60 months.\n\n* The primary safety endpoint of the study is the Type I (caused by the S-ICD System) Complication Free Rate at 60 months compared to a performance goal of 85%.\n* The primary effectiveness endpoint is the Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of ventricular tachycardia /ventricular fibrillation (VT/VF) through 60 months compared to a performance goal of 94%.\n* The secondary safety endpoint of the study is the Electrode-Related Complication Free Rate at 60 months compared to a performance goal of 92.5%.\n* The secondary effectiveness endpoint is First Shock Effectiveness in Converting Induced (Acute) and Spontaneous Discrete Episodes of VT/VF through 60 months compared to a performance goal of 84.0%.\n\nAdditional objectives include characterization of long term safety and effectiveness in subjects of varied body habitus and in traditionally underrepresented populations.\n\nSubjects must meet the following criteria to be eligible for inclusion in the study:\n\n1. Eligible for implantation with an S-ICD System, OR previously implanted with an S-ICD System in the S-ICD System Clinical Investigation (IDE G090013)\n2. Willing and able to provide written informed consent or have informed consent provided by a legal representative\n\nSubjects who meet the following criteria must be excluded from the study:\n\n1\\. Remaining life expectancy of less than 360 days\n\nEnrolled subjects will be followed at the implant procedure, pre-discharge and annual (±60 days) follow-up visits. 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