Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-03-05 @ 8:51 AM
Study NCT ID:
NCT02030418
Status:
COMPLETED
Last Update Posted:
2025-07-09
First Post:
2014-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001919', 'term': 'Bradycardia'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nicole.harbert@abbott.com', 'phone': '972-526-4841', 'title': 'Nicole Harbert, Director Clinical Research', 'organization': 'Abbott Cardiac Rhythm Management'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Although the LEADLESS II Phase 1 study met the primary and secondary endpoints, the Nanostim LP device was not commercialized in the US and commercial sales in the EU were discontinued in 2016. The Nanostim LP device was redesigned into the Aveir VR LP device- evaluated in the LEADLESS II Phase 2 study (NCT04559945.)'}}, 'adverseEventsModule': {'timeFrame': 'Mean follow-up of 44.2 months post-implant (median 40.9 months)', 'description': 'Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.', 'eventGroups': [{'id': 'EG000', 'title': 'Leadless Pacemaker', 'description': 'Subjects who signed an approved informed consent form and had an attempted Nanostim implant, with no pre-existing implanted pacemaker at the time of consent', 'otherNumAtRisk': 952, 'deathsNumAtRisk': 952, 'otherNumAffected': 236, 'seriousNumAtRisk': 952, 'deathsNumAffected': 276, 'seriousNumAffected': 436}], 'otherEvents': [{'term': 'Inadequate Fixation of The LP', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Premature Battery Depletion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 44, 'numAffected': 43}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Vascular Access Complication: Access Site Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Reaction to Contrast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Costochondritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Threshold Elevation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Accidental Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Reaction to Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Unsuccessful LP Retrieval', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Undersensing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cardiac Arrhythmias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 22, 'numAffected': 20}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Detached Docking Button', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pre-Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hematoma Formation, Including Retroperitoneal Hematoma/Hemorrahge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Tricuspid Valve Regurgitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pacemaker Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'RV Pacing Induced Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Coughing With RV Pacing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Exit Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Inability to Interrogate or Program due to Programmer or Device Malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Infection, Local at Access Site, or Systemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Loss of Normal Device Function due to Component Malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Temporary Loss of Vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Mild Skin Reaction to Pre-Procedural Prep', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Open Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hand Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Nickel Allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Upper Respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Mechanical Trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cardiac Perforation/Pericardial Effusion not Requiring Intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Valve Damage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Inability to Release Snare from Docking Button', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'High Impedance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Myalgias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Left Sided Numbness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Helix Distortion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Migraines', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Failure to Capture/Loss of Capture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Vascular Access Complication: Access Site Lymphatic Drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Access Site Bleeding Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Memory Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Abscess of The Neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Rectal Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Extra-Cardiac Pacing Stimulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Polyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Gastroesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Stasis Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hyperbilirubinemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Skin Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Transient Ischemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Thromboemboli', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Intermittent Loss of Device Telemetry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Essential Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Elevated Troponin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Vascular Access Complication: AV Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Contrast Extravasation at Groin Access Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Anesthesia Related Side Effect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Interruption of Desired Pacemaker Function due to Electrical Interference', 'notes': 'Either Electromyogenic or Electromagnetic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Chest Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Elevated Inr', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Uvulitis After Implant Procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Tricuspid Regurgitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pleural Effusions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Spine Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Aortic Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Choking', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Asystole During Implant Procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}], 'seriousEvents': [{'term': 'Malignant Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Premature Battery Depletion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 180, 'numAffected': 176}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Loss of Normal Device Function due to Component Malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Peripheral Vascular Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 52, 'numAffected': 43}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cardiac Perforation Resulting in Tamponade and Requiring Intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Infection, Local at Access Site, or Systemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 22, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Vascular Access Complication: Access Site Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 25, 'numAffected': 18}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Choledocholithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cardiac Arrhythmias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 23, 'numAffected': 21}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Elective Device Replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 16, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Rib and Vertebra Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Decreased Level of Consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Accidental Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hematoma Formation, Including Retroperitoneal Hematoma/Hemorrahge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cardiac Perforation/Pericardial Effusion not Requiring Intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Device Dislodgement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Left Leg Weakness During Implant Procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Threshold Elevation Resulting in Second LP Implant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cardiac Perforation Requiring Intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Valve Damage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Change in Mental Status Post Procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Intermittent Capture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pericardial Effusion or Rub', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Mechanical Trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 16, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Terminal Heart Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cardiopulmonary Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'GI Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Acute Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Celulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Inability to Interrogate or Program due to Programmer or Device Malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pacemaker Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Fever- Unknown Etiology', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pulseless Electrical Activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Change in Mental Status', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Peripheral Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Aortic Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Death, Unknown Cause', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Threshold Elevation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Multi-System Organ Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Rectal Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Vascular Access Complication: Pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Detached Docking Button', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Ventricular Ectopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Access Site Bleeding Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pre-Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Temporary Loss of Pacing and Sensing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'RV Lead Dislodgement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Reduction in Lvef', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Threshold Elevation Resulting in Retrieval of LP', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Undifferentiated Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pocket Hematoma (Pm)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Damage to Vessels', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Transient Ischemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Allergic Reaction to Vancomycin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Inadequate Fixation of The LP During Implant Resulting in Device Migration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Device Pocket Infection (Biv ICD)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Femoral-Popliteal Bypass Graft Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Thromboemboli', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Asystole During Implant Procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Intermittent Loss of Device Telemetry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Excessive Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'End Stage Renal Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Vascular Access Complication: AV Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Failure to Capture/Loss of Capture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Leg Ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Intracranial Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Aortic Dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'RV Pacing Induced Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Shoulder Dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Mechanical Trauma to His Bundle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Contrast Induced Nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Endocarditis of Prosthetic Valves', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hand Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': "Bell's Palsy", 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Tricuspid Valve Regurgitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Intermittent Complete Heart Block During Implant Procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Perclose System Malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 952, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Complication-Free Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Leadless Pacemaker', 'description': 'Subjects who signed an approved informed consent form and had an attempted Nanostim implant, with no pre-existing implanted pacemaker at the time of consent'}], 'classes': [{'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000', 'lowerLimit': '89.9', 'upperLimit': '95.9'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'binomial proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '93.3', 'ciLowerLimit': '89.9', 'ciUpperLimit': '95.9', 'statisticalMethod': '1-sided exact test for binomial proporti', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The primary safety hypothesis is:\n\nH0: CFR ≤ 86% vs. H1: CFR \\> 86% Where CFR is the Complication Free Rate. The CFR is estimated as a binomial proportion and the 95% confidence interval (CI) of CFR is calculated using the Clopper-Pearson exact method. The null hypothesis is rejected at the 2.5% significance level if the lower bound of this CI exceeds the Performance Goal (PG) of 86%.'}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Complication is any device-or-procedure related serious adverse event, or serious adverse device effect, including those that prevented initial implantation. Percentage of participants free from complications are reported', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of the primary safety and effectiveness endpoints are performed on the Intent to treat (ITT) population. The ITT population is defined as subjects who meet enrollment criteria, provide signed informed consent, and who have an attempted implant of the LP. The study required a sample size of 300 evaluable subjects. The 300-subject primary analysis cohort is defined as the first 300 enrolled subjects sorted by implant date and sheath insertion time.'}, {'type': 'PRIMARY', 'title': 'Pacing Thresholds and R-wave Amplitudes Within the Therapeutic Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Leadless Pacemaker', 'description': 'Subjects who signed an approved informed consent form and had an attempted Nanostim implant, with no pre-existing implanted pacemaker at the time of consent'}], 'classes': [{'categories': [{'measurements': [{'value': '93.4', 'groupId': 'OG000', 'lowerLimit': '89.9', 'upperLimit': '96.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'binomial proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '93.4', 'ciLowerLimit': '89.9', 'ciUpperLimit': '96.0', 'pValueComment': 'The null hypothesis is rejected at the 2.5% significance level if the lower bound of the CI exceeds the Performance Goal (PG) of 85%.', 'statisticalMethod': '1-sided exact test for binomial proporti', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The primary effectiveness hypothesis is:\n\nH0: Rate ≤ 85.0% vs. H1: Rate \\> 85.0%\n\nwhere Rate is the proportion of subjects experiencing success, and success is defined as: pacing threshold voltage ≤ 2.0 V at 0.4 ms at 6-month visit and sensed R-wave amplitude either ≥ 5.0 mV at the 6-month visit or ≥ value at implant.'}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Success Rate is percentage of subjects who have acceptable pacing threshold and sensing amplitudes, which are defined as pacing threshold \\<=2.0V at 0.4 ms pulse width and R-wave amplitude either =\\>5.0 mV at the 6 month visit or =\\> value at implant.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of the primary effectiveness endpoints was performed on subjects in the Intent to treat (ITT) population with a successful Nanostim Leadless Pacemaker implanted. This number included 289 of the 300 (96.3%) subjects in the ITT population.'}, {'type': 'SECONDARY', 'title': 'Appropriate and Proportional Rate Response During Graded Exercise Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Leadless Pacemaker', 'description': 'Subjects who signed an approved informed consent form and had an attempted Nanostim implant, with no pre-existing implanted pacemaker at the time of consent'}], 'classes': [{'categories': [{'measurements': [{'value': '0.83', 'groupId': 'OG000', 'lowerLimit': '0.73', 'upperLimit': '0.93'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.73', 'ciUpperLimit': '0.93', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.27', 'statisticalMethod': 'two 1-sided test (TOST)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The hypothesis is intended to test whether the mean slope is within 35% of 1. The hypothesis is stated as follows:\n\nH0: absolute value (Mean Slope - 100%) ≥ equivalence margin, equal to 35%\n\nH1: absolute value (Mean Slope - 100%) \\< equivalence margin, equal to 35%\n\nThe calculation of slope for individual subjects in the CAEP exercise protocol is done by setting the y-intercept to zero.'}], 'paramType': 'MEAN', 'timeFrame': '3-6 months', 'description': 'Temperature-based rate response feature was evaluated to determine whether an appropriate and proportional rate response was achieved during maximal effort graded treadmill exercise testing protocol (CAEP). All capable subjects who have completed the 6-minute walk test (6MWT) were asked to perform a maximal effort CAEP exercise protocol to demonstrate an appropriate and proportional response of sensor-indicated rate in graded exercise tests.\n\nData from subjects who have completed the 6MWT and have completed at least stage 3 of the CAEP exercise protocol, or 3.6 metabolic equivalent of task (METs), were included in the analysis.', 'unitOfMeasure': '1/(minutes*metabolic equivalent task)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects within the enrolled population with a successful implant who completed the six-minute walk test and completed at least stage 3 of the CAEP.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Leadless Pacemaker', 'description': 'VVIR pacing\n\nLeadless Pacemaker: Patients will undergo an attempted leadless pacemaker implant'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '952'}]}, {'type': 'Successful Implants', 'achievements': [{'groupId': 'FG000', 'numSubjects': '917'}]}, {'type': '2-Week Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '904'}]}, {'type': '6-Week Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '884'}]}, {'type': '3-Month Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '869'}]}, {'type': '6-Month Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '844'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '808'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '78'}]}, {'type': 'Missed 12-Month Visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '57'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Leadless Pacemaker', 'description': 'VVIR pacing\n\nLeadless Pacemaker: Patients will undergo an attempted leadless pacemaker implant'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '75.4', 'spread': '12.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '359', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '593', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '913', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}]}]}, {'title': 'White or Caucasian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '862', 'groupId': 'BG000'}]}]}, {'title': 'Other (Not Specified)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'American Indian / Alaska Native', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '827', 'groupId': 'BG000'}]}]}, {'title': 'Australia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pacemaker Indication', 'classes': [{'title': 'Chronic AF with 2nd or 3rd Degree AV Block or Bundle Branch Block, including slow ventricular rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '529', 'groupId': 'BG000'}]}]}, {'title': 'Sinus Rhythm with 2nd or 3rd Degree AV Block or Byundle Branch Block', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}]}]}, {'title': 'Sinus Bradycardia with Infrequent Pauses or Unexplained Syncope', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '330', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'LV Ejection Fraction', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '850', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '57.9', 'spread': '8.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '850 patients reporting LV ejection fraction data'}, {'title': 'Congestive Heart Failure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '149', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'NYHA Class', 'classes': [{'title': 'Class I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}, {'title': 'Class II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}]}]}, {'title': 'Class III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': 'Not Done', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'The NYHA Functional Classification is used to classify people with heart failure:\n\nI No limitation of physical activity. Ordinary activity does not cause undue fatigue, palpitation or shortness of breath.\n\nII Slight limitation of physical activity. Comfortable at rest. Ordinary activity results in fatigue, palpitation, shortness of breath or chest pain.\n\nIII Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain.\n\nIV Symptoms of heart failure at rest. Any physical activity causes discomfort.', 'unitOfMeasure': 'participants', 'populationDescription': 'NYHA Class evaluated for patients with congestive heart failure'}, {'title': 'Hypertension', 'classes': [{'title': 'Controlled with Medication(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '736', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '690', 'groupId': 'BG000'}]}]}, {'title': 'Uncontrolled', 'denoms': [{'units': 'Participants', 'counts': [{'value': '736', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}, {'title': 'Controlled Without Medication(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '736', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': '736 patients reporting hypertension'}, {'title': 'Diabetes', 'classes': [{'title': 'Type I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Type II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '228', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': '242 patients reporting diabetes'}, {'title': 'Diabetes Current Status', 'classes': [{'title': 'Controlled with Diet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}, {'title': 'Controlled with Medication(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '191', 'groupId': 'BG000'}]}]}, {'title': 'Uncontrolled', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': '242 patients reporting diabetes'}, {'title': 'Hyperlipidemia', 'classes': [{'title': 'Hyperlipidemia Controlled with Diet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '615', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000'}]}]}, {'title': 'Hyperlipidemia Controlled with Medication(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '615', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '509', 'groupId': 'BG000'}]}]}, {'title': 'Uncontrolled Hyperlipidemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '615', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': '615 patients reporting hyperlipidemia'}, {'title': 'Peripheral Vascular Disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '113', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Cardiac Pulmonary History', 'classes': [{'title': 'Coronary Artery Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '334', 'groupId': 'BG000'}]}]}, {'title': 'Myocardial Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '127', 'groupId': 'BG000'}]}]}, {'title': 'Unstable Angina', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}, {'title': 'Prior PTCA / Stents / Atherectomy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '144', 'groupId': 'BG000'}]}]}, {'title': 'Prior CABG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '129', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Prior Ablation', 'classes': [{'title': 'AV Nodal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': 'AFib / Aflutter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}]}]}, {'title': 'VT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Mini Maze, Thorascope / LAA Ligation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'SVT/AVNRT Ablation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Wolff-Parkinson-White Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Unkown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Tricuspid Valve Disease', 'classes': [{'title': 'Insufficiency / Prolapse / Regurgitation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '184', 'groupId': 'BG000'}]}]}, {'title': 'Repair / Replacement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Arrhythmia History', 'classes': [{'title': 'Ventricular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}, {'title': 'Non-Ventricular / Supraventricular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '727', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Medications', 'classes': [{'title': 'Antiarrhythmics (Class I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'Antiarrhythmics (Class III)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}]}]}, {'title': 'Anticoagulants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '571', 'groupId': 'BG000'}]}]}, {'title': 'Antiplatelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '407', 'groupId': 'BG000'}]}]}, {'title': 'ACE Inhibitors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '249', 'groupId': 'BG000'}]}]}, {'title': 'Angiotensin Receptor Blockers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '167', 'groupId': 'BG000'}]}]}, {'title': 'Beta Blockers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '357', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Enrolled Population (De Novo)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-08', 'size': 9884358, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-11-06T17:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 952}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-20', 'studyFirstSubmitDate': '2014-01-06', 'resultsFirstSubmitDate': '2025-04-30', 'studyFirstSubmitQcDate': '2014-01-06', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-20', 'studyFirstPostDateStruct': {'date': '2014-01-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complication-Free Rate', 'timeFrame': '6 months', 'description': 'Complication is any device-or-procedure related serious adverse event, or serious adverse device effect, including those that prevented initial implantation. Percentage of participants free from complications are reported'}, {'measure': 'Pacing Thresholds and R-wave Amplitudes Within the Therapeutic Range', 'timeFrame': '6 months', 'description': 'Success Rate is percentage of subjects who have acceptable pacing threshold and sensing amplitudes, which are defined as pacing threshold \\<=2.0V at 0.4 ms pulse width and R-wave amplitude either =\\>5.0 mV at the 6 month visit or =\\> value at implant.'}], 'secondaryOutcomes': [{'measure': 'Appropriate and Proportional Rate Response During Graded Exercise Testing', 'timeFrame': '3-6 months', 'description': 'Temperature-based rate response feature was evaluated to determine whether an appropriate and proportional rate response was achieved during maximal effort graded treadmill exercise testing protocol (CAEP). All capable subjects who have completed the 6-minute walk test (6MWT) were asked to perform a maximal effort CAEP exercise protocol to demonstrate an appropriate and proportional response of sensor-indicated rate in graded exercise tests.\n\nData from subjects who have completed the 6MWT and have completed at least stage 3 of the CAEP exercise protocol, or 3.6 metabolic equivalent of task (METs), were included in the analysis.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Bradycardia']}, 'referencesModule': {'references': [{'pmid': '27932427', 'type': 'DERIVED', 'citation': 'Reddy VY, Miller MA, Knops RE, Neuzil P, Defaye P, Jung W, Doshi R, Castellani M, Strickberger A, Mead RH, Doppalapudi H, Lakkireddy D, Bennett M, Sperzel J. Retrieval of the Leadless Cardiac Pacemaker: A Multicenter Experience. Circ Arrhythm Electrophysiol. 2016 Dec;9(12):e004626. doi: 10.1161/CIRCEP.116.004626.'}, {'pmid': '26321198', 'type': 'DERIVED', 'citation': 'Reddy VY, Exner DV, Cantillon DJ, Doshi R, Bunch TJ, Tomassoni GF, Friedman PA, Estes NA 3rd, Ip J, Niazi I, Plunkitt K, Banker R, Porterfield J, Ip JE, Dukkipati SR; LEADLESS II Study Investigators. Percutaneous Implantation of an Entirely Intracardiac Leadless Pacemaker. N Engl J Med. 2015 Sep 17;373(12):1125-35. doi: 10.1056/NEJMoa1507192. Epub 2015 Aug 30.'}]}, 'descriptionModule': {'briefSummary': 'Prospective, non-randomized, single-arm, international multicenter, clinical safety and effectiveness of a leadless pacemaker system in patients who are indicated for a VVIR pacemaker.\n\nFollowing completion of enrollments in the IDE, patients will continue to be enrolled in the continued access phase of the study under the same protocol.', 'detailedDescription': 'The purpose of this study is to evaluate the safety and effectiveness of the leadless pacemaker system in treating patients with a slow heart rate or irregular heartbeats. The Nanostim leadless pacemaker provides bradycardia pacing as a pulse generator with built-in battery and electrodes, for permanent implantation in the right ventricle. As a leadless pacemaker, it does not need a connector, pacing lead, or pulse generator pocket, but it has the same operating principles as a conventional pacemaker.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject must have one of the clinical indications before device implant in adherence with Medicare, ACC/AHA/HRS/ESC single chamber pacing guidelines including:\n\n * Chronic and/or permanent atrial fibrillation with 2 or 3° AV or bifascicular bundle branch block (BBB block), including slow ventricular rates (with or without medication) associated with atrial fibrillation; or\n * Normal sinus rhythm with 2 or 3° AV or BBB block and a low level of physical activity or short expected lifespan (but at least one year); or\n * Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings; and\n2. Subject ≥18 years of age; and\n3. Subject has life expectancy of at least one year; and\n4. Subject is not enrolled in another clinical investigation; and\n5. Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and\n6. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the IRB; and\n7. Subject is not pregnant and does not plan to get pregnant during the course of the study.\n\nExclusion Criteria:\n\n1. Subject has pacemaker syndrome, has retrograde VA conduction or suffers a drop in arterial blood pressure with the onset of ventricular pacing; or\n2. Subject is allergic or hypersensitive to \\<1 mg of dexamethasone sodium phosphate; or\n3. Subject has a mechanical tricuspid valve prosthesis; or\n4. Subject has a pre-existing endocardial pacing or defibrillation leads; or\n5. Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT); or\n6. Subject has an implanted vena cava filter; or\n7. Subject has evidence of thrombosis in one of the veins used for access during the procedure; or\n8. Subject has an implanted leadless cardiac pacemaker; or\n9. Subject had recent cardiovascular or peripheral vascular surgery within 30 days of enrollment'}, 'identificationModule': {'nctId': 'NCT02030418', 'briefTitle': 'The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'The LEADLESS II IDE Study (Phase I): Safety and Effectiveness Trial for the Nanostim Leadless Pacemaker', 'orgStudyIdInfo': {'id': 'DC-02374'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Leadless Pacemaker', 'description': 'VVIR pacing', 'interventionNames': ['Device: Leadless Pacemaker']}], 'interventions': [{'name': 'Leadless Pacemaker', 'type': 'DEVICE', 'description': 'Patients will undergo an attempted leadless pacemaker implant', 'armGroupLabels': ['Leadless Pacemaker']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University Hospital - Univ. of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Heart Center Research, LLC.', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Health', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC University Hospital', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'El Camino Hospital', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Premier Cardiology, Inc', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Huntington Memorial Hospital', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '94303', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'Sequoia Hospital', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '95819', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Mercy Medical Group - Cardiology', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '80120', 'city': 'Littleton', 'state': 'Colorado', 'country': 'United States', 'facility': 'South Denver Cardiology Associates PC', 'geoPoint': {'lat': 39.61332, 'lon': -105.01665}}, {'zip': '34102', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'Naples Community Hospital', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'AdventHealth Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Health', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30306', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Athens Regional Medical Center', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}, {'zip': '30165', 'city': 'Rome', 'state': 'Georgia', 'country': 'United States', 'facility': 'Redmond Regional Medical Center', 'geoPoint': {'lat': 34.25704, 'lon': -85.16467}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60453', 'city': 'Oak Lawn', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Christ Medical Center', 'geoPoint': {'lat': 41.71087, 'lon': -87.75811}}, {'zip': '46845', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Parkview Research Center', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas University Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '41017', 'city': 'Edgewood', 'state': 'Kentucky', 'country': 'United States', 'facility': 'St. Elizabeth Medical Center', 'geoPoint': {'lat': 39.01867, 'lon': -84.58189}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Baptist Health Lexington', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': 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