Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2026-01-05 @ 5:50 PM
Study NCT ID:
NCT03103503
Status:
TERMINATED
Last Update Posted:
2020-10-14
First Post:
2017-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Plexa ICD Lead Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'crystal.miller@biotronik.com', 'phone': '800-547-0394', 'title': 'Clinical Studies Engineer Manager', 'organization': 'BIOTRONIK'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Though study exit or study termination, an average of 1.1 years', 'description': 'Serious adverse events were defined according to ISO14155.', 'eventGroups': [{'id': 'EG000', 'title': 'BIOTRONIK Plexa ICD Lead', 'description': 'Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.', 'otherNumAtRisk': 901, 'deathsNumAtRisk': 901, 'otherNumAffected': 12, 'seriousNumAtRisk': 901, 'deathsNumAffected': 64, 'seriousNumAffected': 44}], 'otherEvents': [{'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 901, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-healing pocket dehiscence requiring intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 901, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Slow wound healing, no sign for infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 901, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 901, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'LV lead related extracardiac stimulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 901, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'LV lead related lead impedance out of range, high', 'stats': [{'groupId': 'EG000', 'numAtRisk': 901, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RV lead related lead dislodgement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 901, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RV lead related other: positional atrial undersensing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 901, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 901, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RA lead related lead dislodgement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 901, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RA lead related no capture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 901, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 901, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 901, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Loose set-screw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 901, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-healing pocket dehiscence requiring intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 901, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiogenic shock during implantation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 901, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Operation wound bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 901, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Venous occlusion associated with the implant procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 901, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'LV lead related high pacing threshold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 901, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'LV lead related lead dislodgement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 901, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': "Twiddler's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 901, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RV lead related lead dislodgement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 901, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RV lead related other: high defibrillation threshold.no evidence for lead malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 901, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RA lead related lead dislodgement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 901, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Emboli', 'stats': [{'groupId': 'EG000', 'numAtRisk': 901, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RV lead related high pacing threshold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 901, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RV lead related intermittent capture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 901, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RV lead related lead impedance out of range, high', 'stats': [{'groupId': 'EG000', 'numAtRisk': 901, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RV lead related lead undersensing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 901, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects Free From Plexa Lead Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '901', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BIOTRONIK Plexa ICD Lead', 'description': 'Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '99.49', 'upperLimit': '100.00'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2.5 years', 'description': 'Evaluate the percentage of subjects without an adverse event related to the Plexa lead through study termination. The endpoint is analyzed as the adverse event free-rate. All protocol defined adverse events that occurred more than 30 days after implant and determined to be related to the Plexa lead plus required invasive intervention to resolve or were related to a lead integrity or clinical performance issue were included. Events meeting this criteria but occurring within 30 days were also included except for lead dislodgement, high pacing threshold, failure to capture, or intermittent capture.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plexa Lead Safety-Individual Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BIOTRONIK Plexa ICD Lead', 'description': 'Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.'}], 'timeFrame': 'Up to 2.5 years', 'description': "Evaluate the individual types of adverse events contributing to primary outcome measure 'Percentage of Subjects Free From Plexa Lead Related Adverse Events'", 'reportingStatus': 'POSTED', 'populationDescription': 'No primary outcome adverse events were reported; therefore, there are no individual events to be analyzed.'}, {'type': 'SECONDARY', 'title': 'Pacing Threshold Measurements for the Plexa Lead Through Study Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '901', 'groupId': 'OG000'}]}, {'units': 'visits with measurement', 'counts': [{'value': '3714', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BIOTRONIK Plexa ICD Lead', 'description': 'Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.63', 'spread': '0.28', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2.5 years', 'description': 'Pacing threshold measurements at pulse width of 0.4 for the Plexa leads at completed follow-up visits.', 'unitOfMeasure': 'V', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'visits with measurement', 'denomUnitsSelected': 'visits with measurement'}, {'type': 'SECONDARY', 'title': 'Sensing Measurements for the Plexa Lead Through Study Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '901', 'groupId': 'OG000'}]}, {'units': 'visits with measurement', 'counts': [{'value': '3746', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BIOTRONIK Plexa ICD Lead', 'description': 'Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.88', 'spread': '5.56', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2.5 years', 'description': 'Sensing measurements for the Plexa leads at completed follow-up visits.', 'unitOfMeasure': 'mV', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'visits with measurement', 'denomUnitsSelected': 'visits with measurement'}, {'type': 'SECONDARY', 'title': 'Pacing Impedance Measurements for the Plexa Lead Through Study Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '901', 'groupId': 'OG000'}]}, {'units': 'visits with measurement', 'counts': [{'value': '3925', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BIOTRONIK Plexa ICD Lead', 'description': 'Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.'}], 'classes': [{'categories': [{'measurements': [{'value': '567.1', 'spread': '111.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2.5 years', 'description': 'Pacing impedance measurements for the Plexa leads at completed follow-up visits.', 'unitOfMeasure': 'ohms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'visits with measurement', 'denomUnitsSelected': 'visits with measurement'}, {'type': 'SECONDARY', 'title': 'Shock Impedance for the Plexa Lead Through Study Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '901', 'groupId': 'OG000'}]}, {'units': 'visits with measurement', 'counts': [{'value': '3913', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BIOTRONIK Plexa ICD Lead', 'description': 'Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.1', 'spread': '13.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2.5 years', 'description': 'Shock impedance measurements for the Plexa leads at completed follow-up visits.', 'unitOfMeasure': 'ohms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'visits with measurement', 'denomUnitsSelected': 'visits with measurement'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Free From Protocol Defined Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '901', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BIOTRONIK Plexa ICD Lead', 'description': 'Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.12', 'groupId': 'OG000', 'lowerLimit': '93.49', 'upperLimit': '96.36'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2.5 years', 'description': "Evaluate the percentage of subjects without a protocol defined and clinical event committee adjudicated adverse event, excluding events included in the primary outcome 'Percentage of Subjects Free From Plexa Lead Related Adverse Events', through study termination. Lead dislodgements, high pacing threshold, failure to capture, and intermittent capture related to the Plexa lead that occurred less than or equal to 30 days after lead implant or a lead revision procedure are included here. The endpoint is analyzed as the adverse event free-rate.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BIOTRONIK Plexa ICD Lead', 'description': 'Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '901'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '901'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '64'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '57'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Plexa Lead or Pulse Generator Extraction', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Study Closure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '757'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '901', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'BIOTRONIK Plexa ICD Lead', 'description': 'Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '894', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '64.35', 'spread': '12.59', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data collected and analyzed when available, not all subjects had data available for this measurement.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '894', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '237', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '657', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data collected and analyzed when available, not all subjects had data available for this measurement.'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '874', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '68.5', 'spread': '4.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'inches', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data collected and analyzed when available, not all subjects had data available for this measurement.'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '880', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '207.2', 'spread': '57.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pounds', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data collected and analyzed when available, not all subjects had data available for this measurement.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-01', 'size': 2211461, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-01-16T12:20', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 901}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Collection of long term lead performance is being transferred to an alternate data collection methodology.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-18', 'studyFirstSubmitDate': '2017-03-31', 'resultsFirstSubmitDate': '2020-08-25', 'studyFirstSubmitQcDate': '2017-03-31', 'lastUpdatePostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-18', 'studyFirstPostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects Free From Plexa Lead Related Adverse Events', 'timeFrame': 'Up to 2.5 years', 'description': 'Evaluate the percentage of subjects without an adverse event related to the Plexa lead through study termination. The endpoint is analyzed as the adverse event free-rate. All protocol defined adverse events that occurred more than 30 days after implant and determined to be related to the Plexa lead plus required invasive intervention to resolve or were related to a lead integrity or clinical performance issue were included. Events meeting this criteria but occurring within 30 days were also included except for lead dislodgement, high pacing threshold, failure to capture, or intermittent capture.'}], 'secondaryOutcomes': [{'measure': 'Plexa Lead Safety-Individual Adverse Events', 'timeFrame': 'Up to 2.5 years', 'description': "Evaluate the individual types of adverse events contributing to primary outcome measure 'Percentage of Subjects Free From Plexa Lead Related Adverse Events'"}, {'measure': 'Pacing Threshold Measurements for the Plexa Lead Through Study Termination', 'timeFrame': 'Up to 2.5 years', 'description': 'Pacing threshold measurements at pulse width of 0.4 for the Plexa leads at completed follow-up visits.'}, {'measure': 'Sensing Measurements for the Plexa Lead Through Study Termination', 'timeFrame': 'Up to 2.5 years', 'description': 'Sensing measurements for the Plexa leads at completed follow-up visits.'}, {'measure': 'Pacing Impedance Measurements for the Plexa Lead Through Study Termination', 'timeFrame': 'Up to 2.5 years', 'description': 'Pacing impedance measurements for the Plexa leads at completed follow-up visits.'}, {'measure': 'Shock Impedance for the Plexa Lead Through Study Termination', 'timeFrame': 'Up to 2.5 years', 'description': 'Shock impedance measurements for the Plexa leads at completed follow-up visits.'}, {'measure': 'Percentage of Subjects Free From Protocol Defined Adverse Events', 'timeFrame': 'Up to 2.5 years', 'description': "Evaluate the percentage of subjects without a protocol defined and clinical event committee adjudicated adverse event, excluding events included in the primary outcome 'Percentage of Subjects Free From Plexa Lead Related Adverse Events', through study termination. Lead dislodgements, high pacing threshold, failure to capture, and intermittent capture related to the Plexa lead that occurred less than or equal to 30 days after lead implant or a lead revision procedure are included here. The endpoint is analyzed as the adverse event free-rate."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Implantable Defibrillator User']}, 'descriptionModule': {'briefSummary': "The purpose of this registry is to confirm the long-term safety and reliability of BIOTRONIK's Plexa ICD lead."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The subject selected for participation should be from the investigator's general patient population according to the inclusion and exclusion criteria.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Successfully implanted with a BIOTRONIK ICD or CRT-D compatible system along with the Plexa lead no more than 30 days prior to consent\n* Able to understand the nature of the registry and provide informed consent\n* Available for follow-up visits on a regular basis at the study site for the expected 5 years of follow-up\n* Accepts BIOTRONIK Home Monitoring® concept\n* Age greater than or equal to 18 years\n\nExclusion Criteria:\n\n* Enrolled in any investigational cardiac device trial\n* Enrolled in BIOTRONIK's QP ExCELs lead study\n* Planned cardiac surgical procedures or interventional measures within the next 6 months\n* Expected to receive heart transplantation or ventricular assist device within 1 year\n* Life expectancy of less than 1 year\n* Patients reporting pregnancy at the time of enrollment"}, 'identificationModule': {'nctId': 'NCT03103503', 'briefTitle': 'Plexa ICD Lead Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik, Inc.'}, 'officialTitle': 'Plexa ICD Lead Registry', 'orgStudyIdInfo': {'id': 'Plexa Registry'}}, 'contactsLocationsModule': {'locations': [{'zip': '36532', 'city': 'Fairhope', 'state': 'Alabama', 'country': 'United States', 'facility': 'Thomas Hospital Research Office', 'geoPoint': {'lat': 30.52297, 'lon': -87.90333}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jeffrey S Goodman MD', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92270', 'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', 'facility': 'Eisenhower Desert Cardiology', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Advent Health Tampa', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '62002', 'city': 'Alton', 'state': 'Illinois', 'country': 'United States', 'facility': 'St. Louis Cardiology Consultants', 'geoPoint': {'lat': 38.8906, 'lon': -90.18428}}, {'zip': '52242', 'city': 'Iowa 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