Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT04351269
Status:
COMPLETED
Last Update Posted:
2023-07-21
First Post:
2020-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Retrospective Experience Of CIED Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical@aziyo.com', 'phone': '470-514-4085', 'title': 'Associate Director of Clinical Operations', 'organization': 'Aziyo Biologics, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The limitations of this study are its retrospective, observational nature, non-randomized design, limited duration of follow up, and single-physician design. The lack of randomization may introduce bias in the selection of patients for implantation with CIED envelopes and in the choice between CanGaroo and TYRX Envelopes. Finally, the duration of follow up may not have captured late adverse events, limiting data on longer-term outcomes.'}}, 'adverseEventsModule': {'timeFrame': '12 months post-procedure', 'eventGroups': [{'id': 'EG000', 'title': 'CanGaroo Envelope', 'description': 'Patients who received a CanGaroo Envelope with their CIED implantation.\n\nCanGaroo Envelope: CanGaroo Envelope with CIED implantation', 'otherNumAtRisk': 165, 'deathsNumAtRisk': 165, 'otherNumAffected': 0, 'seriousNumAtRisk': 165, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'TYRX Envelope', 'description': 'Patients who received a TYRX Envelope with their CIED implantation.\n\nTYRX Envelope: TYRX Envelope with CIED implantation', 'otherNumAtRisk': 219, 'deathsNumAtRisk': 219, 'otherNumAffected': 0, 'seriousNumAtRisk': 219, 'deathsNumAffected': 10, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'No Envelope', 'description': 'Patients who had their CIED implanted with no envelope.', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 71, 'otherNumAffected': 0, 'seriousNumAtRisk': 71, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 219, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pocket Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lead Dislodgement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Superficial Surgical Site Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lead Revision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lead Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Major Infection Post Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CanGaroo Envelope', 'description': 'Patients who received a CanGaroo Envelope with their CIED implantation.\n\nCanGaroo Envelope: CanGaroo Envelope with CIED implantation'}, {'id': 'OG001', 'title': 'TYRX Envelope', 'description': 'Patients who received a TYRX Envelope with their CIED implantation.\n\nTYRX Envelope: TYRX Envelope with CIED implantation'}, {'id': 'OG002', 'title': 'No Envelope', 'description': 'Patients who had their CIED implanted with no envelope.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months post procedure', 'description': 'Major CIED infections are defined as a CIED infection resulting in one or more of the following:\n\n* CIED system removal\n* Any invasive procedure (e.g., pocket opened) without system removal\n* Treatment with antibiotic therapy if the subject is not a candidate for system removal and infection recurrence after completion of antibiotic therapy or evidence of deep infection with wound dehiscence, erosion, or purulent drainage\n* Death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Pocket Related Issues Prompting an Office Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CanGaroo Envelope', 'description': 'Patients who received a CanGaroo Envelope with their Cardiac Implantable Electronic Device (CIED) implantation.\n\nCanGaroo Envelope: CanGaroo Envelope with Cardiac Implantable Electronic Device (CIED) implantation'}, {'id': 'OG001', 'title': 'TYRX Envelope', 'description': 'Patients who received a TYRX Envelope with their Cardiac Implantable Electronic Device (CIED) implantation.\n\nTYRX Envelope: TYRX Envelope with Cardiac Implantable Electronic Device (CIED) implantation'}, {'id': 'OG002', 'title': 'No Envelope', 'description': 'Patients who had their Cardiac Implantable Electronic Device (CIED) implanted with no envelope.'}], 'classes': [{'title': 'Hematoma', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pocket Infection', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Lead Dislodgement', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Site Drainage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Thrombosis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Superficial Surgical Site Infection (SSI)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Lead Revision', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hemothorax', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Erythema & Fever', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months post procedure', 'description': 'Any pocket related issues that prompted an office visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CanGaroo Envelope', 'description': 'Patients who received a CanGaroo Envelope with their Cardiac Implantable Electronic Device (CIED) implantation.\n\nCanGaroo Envelope: CanGaroo Envelope with Cardiac Implantable Electronic Device (CIED) implantation'}, {'id': 'FG001', 'title': 'TYRX Envelope', 'description': 'Patients who received a TYRX Envelope with their Cardiac Implantable Electronic Device (CIED) implantation.\n\nTYRX Envelope: TYRX Envelope with Cardiac Implantable Electronic Device (CIED) implantation'}, {'id': 'FG002', 'title': 'No Envelope', 'description': 'Patients who had their Cardiac Implantable Electronic Device (CIED) implanted with no envelope.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '237'}, {'groupId': 'FG001', 'numSubjects': '260'}, {'groupId': 'FG002', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '165'}, {'groupId': 'FG001', 'numSubjects': '219'}, {'groupId': 'FG002', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'Subjects did not meet Inclusion criteria after protocol revision B', 'reasons': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '29'}]}, {'type': 'CanGaroo Envelope used during a previous procedure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Subjects had both CanGaroo Envelope and TYRX Envelope used during procedure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Subjects followed long-term at different health care system', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'BG000'}, {'value': '219', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'CanGaroo Envelope', 'description': 'Patients who received a CanGaroo Envelope with their CIED implantation.\n\nCanGaroo Envelope: CanGaroo Envelope with CIED implantation'}, {'id': 'BG001', 'title': 'TYRX Envelope', 'description': 'Patients who received a TYRX Envelope with their CIED implantation.\n\nTYRX Envelope: TYRX Envelope with CIED implantation'}, {'id': 'BG002', 'title': 'No Envelope', 'description': 'Patients who had their CIED implanted with no envelope.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '74.0', 'spread': '13.2', 'groupId': 'BG000'}, {'value': '70.3', 'spread': '13.5', 'groupId': 'BG001'}, {'value': '74.2', 'spread': '11.0', 'groupId': 'BG002'}, {'value': '72.3', 'spread': '13.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '167', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '288', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '433', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '390', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'spread': '6.5', 'groupId': 'BG000'}, {'value': '30.6', 'spread': '7.2', 'groupId': 'BG001'}, {'value': '31.0', 'spread': '6.3', 'groupId': 'BG002'}, {'value': '29.9', 'spread': '6.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-02', 'size': 313949, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-03-04T10:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 597}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-19', 'studyFirstSubmitDate': '2020-04-15', 'resultsFirstSubmitDate': '2022-03-04', 'studyFirstSubmitQcDate': '2020-04-15', 'lastUpdatePostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-04', 'studyFirstPostDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Major Infection Post Procedure', 'timeFrame': '12 months post procedure', 'description': 'Major CIED infections are defined as a CIED infection resulting in one or more of the following:\n\n* CIED system removal\n* Any invasive procedure (e.g., pocket opened) without system removal\n* Treatment with antibiotic therapy if the subject is not a candidate for system removal and infection recurrence after completion of antibiotic therapy or evidence of deep infection with wound dehiscence, erosion, or purulent drainage\n* Death'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Pocket Related Issues Prompting an Office Visit', 'timeFrame': '12 months post procedure', 'description': 'Any pocket related issues that prompted an office visit'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cardiac Disease', 'Heart Failure', 'Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to retrospectively gather information on patients who underwent a CIED procedure with either a CanGaroo Envelope, TYRX Envelope, or no envelope.', 'detailedDescription': 'A single center will retrospectively review up to 700 subjects who underwent implantation of a CIED with a CanGaroo Envelope, TYRX Envelope, or no envelope. All sets of subjects enrolled will also be examined for any follow-up visits and/or adverse events that occurred up to 12 months post-surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male or female patients who underwent a CIED implantation utilizing a CanGaroo Envelope hydrated in saline, a CanGaroo Envelope hydrated in an antibiotic solution, a TYRX Envelope, or no envelope.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient that had a CIED implanted with either a CanGaroo Envelope, a TYRX Envelope, or no envelope on or after March 27, 2017\n\nExclusion Criteria:\n\n* Any patient that had a CIED implanted with any other type of envelope\n* Any patient that had a CIED implanted prior to March 27, 2017'}, 'identificationModule': {'nctId': 'NCT04351269', 'briefTitle': 'Retrospective Experience Of CIED Implantation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Elutia Inc.'}, 'officialTitle': 'Retrospective Experience of CIED Implantation With Piedmont Athens Regional Electrophysiology', 'orgStudyIdInfo': {'id': 'CPR-2212'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CanGaroo Envelope', 'description': 'Patients who received a CanGaroo Envelope with their Cardiac Implantable Electronic Device (CIED) implantation.', 'interventionNames': ['Device: CanGaroo Envelope']}, {'label': 'TYRX Envelope', 'description': 'Patients who received a TYRX Envelope with their Cardiac Implantable Electronic Device (CIED) implantation.', 'interventionNames': ['Device: TYRX Envelope']}, {'label': 'No Envelope', 'description': 'Patients who had their Cardiac Implantable Electronic Device (CIED) implanted with no envelope.'}], 'interventions': [{'name': 'CanGaroo Envelope', 'type': 'DEVICE', 'description': 'CanGaroo Envelope with Cardiac Implantable Electronic Device (CIED) implantation', 'armGroupLabels': ['CanGaroo Envelope']}, {'name': 'TYRX Envelope', 'type': 'DEVICE', 'description': 'TYRX Envelope with Cardiac Implantable Electronic Device (CIED) implantation', 'armGroupLabels': ['TYRX Envelope']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30606', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Athens Electrophysiology', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}], 'overallOfficials': [{'name': 'Jerome Riebman, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aziyo Biologicgs, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elutia Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}