Viewing Study NCT01596595

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Ignite Creation Date: 2025-12-24 @ 2:08 PM
Ignite Modification Date: 2025-12-27 @ 9:54 PM
Study NCT ID: NCT01596595
Status: COMPLETED
Last Update Posted: 2021-03-19
First Post: 2012-05-03
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Longitudinal Surveillance Study of the 4-SITE Lead/Header System
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Paji.Vitoff@bsci.com', 'phone': '651-582-5415', 'title': 'Paji Vitoff, Manager, Clinical Trials', 'organization': 'Boston Scientific'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.', 'eventGroups': [{'id': 'EG000', 'title': 'RELIANCE 4-SITE', 'description': 'All-Cause Mortality and Adverse Events are reported for all enrolled subjects (N=1820).', 'otherNumAtRisk': 1820, 'deathsNumAtRisk': 1820, 'otherNumAffected': 980, 'seriousNumAtRisk': 1820, 'deathsNumAffected': 327, 'seriousNumAffected': 1017}], 'otherEvents': [{'term': 'Oversensing - RA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 8}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Unable to Capture - RA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other - PG System', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oversensing - RV 1120 - Undersensing - RV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated Threshold - RV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 4}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated Threshold - LV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Extracardiac Stimulation - LV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 7}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inappropriate Tachy Therapy - SVT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 43}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inappropriate Tachy Therapy - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 11}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Early ERI - Premature declaration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pacemaker Mediated Tachycardia (PMT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 6}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection (> 30 days post implant)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychological effect due to device therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma- Pocket (>30 days post implant)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Seroma - Pocket (>30 days post implant)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Migration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Post Surgical wound discomfort/bruising/swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 82}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-surgical pocket hemorrhage/bleeding/drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Post -Surgical infection (≤ 30 days post implant)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse Reaction - General', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse Reaction - Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse Reaction - Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse Reaction - Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inadvertent VT/VF', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Physical trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma - pocket (≤ 30 days post-implant)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 72}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Seroma - Pocket (≤ 30 days post implant)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Thromboembolic events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedure - PG System - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oversensing - RA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Undersensing - RA 2032 - Unable to Capture - RA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated Threshold - RA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Extracardiac Stimulation - RA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Conductor Coil Fracture - RA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'High Out of Range Impedance - RA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislodgement - Multiple signs- RA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislodgement - No reported signs - RA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 4}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Lead Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 7}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oversensing - RV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 7}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Undersensing - RV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Unable to Capture - RV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated Threshold - RV 2140 - Extracardiac Stimulation - RV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 12}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Extracardiac Stimulation - RV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 4}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial Perforation post implant- RV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Low Out of Range Impedance - RV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislodgement - Unable to capture - RV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislodgement - Elevated threshold - RV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislodgement - Oversensing- RV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislodgement - Multiple signs - RV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislodgement - No reported signs - RV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Unable to Capture - LV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated Threshold - LV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 8}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Extracardiac Stimulation - LV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 29}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Low Out of Range Impedance - LV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislodgement - Unable to Capture - LV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislodgement - No reported signs - LV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Unable to Convert', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inappropriate tachy therapy - SVT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inappropriate tachy therapy - Noise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Puncture Site hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronotropic Incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricular Fibrillation (VF)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 24}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricular Tachycardia (VT)/Monomorphic VT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 73}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Torsades de Pointes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nonsustained ventricular tachycardia (NSVT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 54}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Fibrillation (AF)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 111}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 28}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 25}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Premature Ventricular Contractions (PVC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 17}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 49}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral edema - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 39}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Edema - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal Failure/Insufficiency - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight Gain - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart Failure Symptoms - Unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 37}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Multiple Heart Failure Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 75}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart Failure Patient Condition - Cardiovascular - OTHER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension/Orthostatic Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 65}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension/Hypertensive Crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 42}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral Vascular Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 27}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Intermittent Claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Aortic Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Aortic Regurgitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mitral Regurgitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 65}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain - Ischemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 83}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 41}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 16}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue/Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 39}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Patient Condition - Cardiovascular - OTHER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 32}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient Ischemic Attack (TIA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular Accident (CVA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep Vein Thrombosis (DVT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Embolism (PE)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Distal thromboemboli', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Intracardiac thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericardial effusion - unrelated procedure/device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericarditis - unrelated procedure/device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma - unrelated procedure/device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Patient Condition - Non-Cardiovascular - OTHER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 109}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'System Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever and/or Virus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Physical Trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 97}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal Laboratory Values', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 95}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 34}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 67}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 166}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 123}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Genitourinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 95}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 74}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 165}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 29}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Integumentary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 99}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Head, eyes, ears, nose, throat (HEENT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 185}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Endocrine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 58}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Immune', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 7}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 34}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Other - PG System', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated Threshold - RV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inappropriate Tachy Therapy - SVT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 30}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inappropriate Tachy Therapy - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 6}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Early ERI - Premature Declaration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pacemaker Mediated Tachycardia (PMT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection (> 30 days post implant)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma- Pocket (>30 days post implant)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Migration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Post Surgical wound discomfort/bruising/swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-surgical pocket hemorrhage/bleeding/drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Post -Surgical infection (≤ 30 days post implant)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse Reaction - Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma - pocket (≤ 30 days post-implant)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Thromboembolic events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedure - PG System - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislodgement - Unable to Capture - RA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislodgement - Multiple signs- RA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislodgement - No reported signs - RA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 4}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Lead Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oversensing - RV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Unable to Capture - RV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated Threshold - RV 2140 - Extracardiac Stimulation - RV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Extracardiac Stimulation - RV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Insulation Breach - RV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial Perforation post implant- RV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Low Out of Range Impedance - RV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislodgement - Unable to capture - RV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislodgement - Elevated threshold - RV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 4}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislodgement - Extracardiac stimulation - RV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislodgement - Multiple signs - RV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislodgement - No reported signs - RV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 4}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Unable to Capture - LV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Extracardiac Stimulation - LV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Conductor Coil Fracture - LV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Insulation Breach - LV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislodgement - Unable to Capture - LV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 4}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislodgement - Elevated threshold - LV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislodgement - Extracardiac stimulation - LV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislodgement - Multiple signs - LV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislodgement - No reported signs - LV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 7}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inappropriate tachy therapy - SVT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial perforation without tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial perforation with tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedure - Lead - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': '3rd Degree AV Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulseless Electrical Activity (PEA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricular Fibrillation (VF)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 29}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricular Tachycardia (VT)/Monomorphic VT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 72}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Torsades de Pointes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nonsustained ventricular tachycardia (NSVT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Fibrillation (AF)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 83}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Premature Ventricular Contractions (PVC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 108}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral edema - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Edema - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal Failure/Insufficiency - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight Gain - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 16}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart Failure Symptoms - Unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 142}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Multiple Heart Failure Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 185}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart Failure Patient Condition - Cardiovascular - OTHER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Multi-system Failure - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension/Orthostatic Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 37}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension/Hypertensive Crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiogenic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 20}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 41}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 62}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral Vascular Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 38}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Intermittent Claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Aortic Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Aortic Regurgitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mitral Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mitral Regurgitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain - Ischemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 19}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 68}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue/Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Multiple Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Patient Condition - Cardiovascular - OTHER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 62}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient Ischemic Attack (TIA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 25}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular Accident (CVA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 51}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep Vein Thrombosis (DVT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Embolism (PE)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 16}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Distal thromboemboli', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericardial effusion - unrelated procedure/device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericarditis - unrelated procedure/device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma - unrelated procedure/device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhage - unrelated procedure/device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Patient Condition - Non-Cardiovascular - OTHER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 47}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'System Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 76}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever and/or Virus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Physical Trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 76}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal Laboratory Values', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 36}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 39}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 54}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 188}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 183}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Genitourinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 50}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 108}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 83}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Integumentary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 39}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Head, eyes, ears, nose, throat (HEENT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Endocrine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 27}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 68}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Multi-System Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1820, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Not Experiencing a System or Procedure Related Complication Through 5-years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1779', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RELIANCE 4-SITE', 'description': 'There were 1820 patients who were consented for participation in the LSS of 4-SITE Study. Of the 1820 participants enrolled 1779 were implanted and followed for the study. There were 11 subjects who were attempted for implant but did not receive a study devices and 30 subjects who were determined to be intent subjects (did not undergo surgery) and were withdrawn from the study. These 41 subjects are not included in the endpoint analysis. The endpoint was analyzed using intent to treat analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.9', 'comment': 'As prespecified in the study protocol the lower one-sided 95% confidence bound of the Kaplan-Meier estimate was compared to the performance goal (i.e., only the lower one-side confidence bound was necessary/utilized for hypothesis testing).', 'groupId': 'OG000', 'lowerLimit': '98.5', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'The 4-SITE Lead/Header System will be evaluated based on the "chronic 4-SITE Lead/Header System-related complication-free rate" for the five (5) year follow-up period after the index implantation. The primary endpoint analysis will include confirmed chronic 4-SITE Lead/Header System-related complications that result in study subject permanent loss of therapy, invasive intervention, injury or death.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RELIANCE 4-SITE', 'description': 'There were 1820 patients who were consented for participation in the LSS of 4-SITE Study. Of the 1820 participants enrolled 1779 were implanted and followed for the study. There were 11 subjects who were attempted for implant but did not receive a study devices and 30 subjects who were determined to be intent subjects (did not undergo surgery) and were withdrawn from the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1779'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '814'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '965'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1790', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'RELIANCE 4-SITE', 'description': 'Baseline characteristics include enrolled subjects who were implanted (1779) or attempted for implant (11) of an ENDOTAK® RELIANCE 4-SITE lead and Boston Scientific pulse generator compatible with the RELIANCE 4-SITE family of cardiac leads. Intent subjects (30) are not included in the baseline characteristics.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.0', 'spread': '12.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '481', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1309', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '1345', 'groupId': 'BG000'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '249', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '106', 'groupId': 'BG000'}]}]}, {'title': 'Not Disclosed', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'Hawaiian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Missing data', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants may contribute to more than one category.', 'unitOfMeasure': 'Participant selections'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '107', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '1681', 'groupId': 'BG000'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline characteristics include enrolled subjects who were implanted (1779) or attempted for implant (11) of an ENDOTAK® RELIANCE 4-SITE lead and Boston Scientific pulse generator compatible with the RELIANCE 4-SITE family of cardiac leads. Intent subjects (30) are not included in the baseline characteristics.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2012-11-02', 'size': 19022937, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-01-19T15:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1820}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-25', 'studyFirstSubmitDate': '2012-05-03', 'resultsFirstSubmitDate': '2021-02-03', 'studyFirstSubmitQcDate': '2012-05-09', 'lastUpdatePostDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-03', 'studyFirstPostDateStruct': {'date': '2012-05-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Not Experiencing a System or Procedure Related Complication Through 5-years', 'timeFrame': '5 years', 'description': 'The 4-SITE Lead/Header System will be evaluated based on the "chronic 4-SITE Lead/Header System-related complication-free rate" for the five (5) year follow-up period after the index implantation. The primary endpoint analysis will include confirmed chronic 4-SITE Lead/Header System-related complications that result in study subject permanent loss of therapy, invasive intervention, injury or death.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ICD', 'CRT-D', 'Defibrillation lead'], 'conditions': ['Primary Prevention of Sudden Cardiac Arrest', 'Secondary Prevention of Sudden Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'Post-approval studies of implanted leads provide an opportunity to observe and assess patient outcomes and technology performance in a real-world setting. The goal of the study is to evaluate, document and report on the appropriate clinical performance, long-term reliability and the functional integrity of the Boston Scientific ENDOTAK RELIANCE® 4-SITE™ Lead and the pulse generator 4-SITE Header.', 'detailedDescription': 'The objective of the LSS of 4-SITE Study is to prospectively determine the chronic complication-free rate of the 4-SITE Lead/Header System in order to verify its clinical performance, long-term reliability and functional integrity. The LSS of 4-SITE Study is a non-randomized, multi-center, global clinical investigation of subjects implanted with the 4-SITE Lead/Header System. The study is designed to collect product performance information, any reportable adverse events and withdrawal data.\n\nThe primary purpose of this study is to evaluate, document and report on the appropriate clinical performance, the long-term reliability and the functional integrity of the 4-SITE Lead/Header System. This 4-SITE Lead/Header System consists of a 4-SITE ENDOTAK® RELIANCE defibrillation lead connected to a 4-SITE Header (which is the only PG component under study) of a single or dual chamber (VR and DR) implantable cardioverter defibrillator (ICD) or a cardiac resynchronization therapy ICD (CRT-D) BSC pulse generator. Additionally, system-related diagnostic information and implant data will be collected during the conduct of this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'From Physicians patient population', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* medically indicated for ICD/CRT-D\n* received/plan to receive study lead\n* willing for long-term follow-up\n\nExclusion Criteria:\n\n* unwilling to comply with protocol'}, 'identificationModule': {'nctId': 'NCT01596595', 'acronym': 'LSS of 4-SITE', 'briefTitle': 'Longitudinal Surveillance Study of the 4-SITE Lead/Header System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Longitudinal Surveillance Study of the 4-SITE Lead/Header System', 'orgStudyIdInfo': {'id': 'LSS of 4-SITE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Medically Indicated for ICD or CRT-D', 'description': 'Medically Indicated for ICD or CRT-D implantation per guidelines'}]}, 'contactsLocationsModule': {'locations': [{'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Providence Alaska Medical Center', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '85032', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Cardiovascular Consultants, LTD', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85206', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Cardiovascular Associates of Mesa', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Cardiovascular Research Group', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Heart Clinic Arkansas', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Providence St. Joseph Medical Center', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'Palomar Medical Center', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'California Heart Associates', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Luc Sinh Nguyen, MD, FACC, Inc.', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Providence Holy Cross Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cardiac Device Rhythm Specialists', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '93309', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Comprehensive Cardiovascular Medical Group', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '62262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'Desert Regional Medical Center', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '92503', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Truong D. 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