Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2025-12-31 @ 6:57 PM
Study NCT ID:
NCT04132466
Status:
COMPLETED
Last Update Posted:
2024-04-05
First Post:
2019-10-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ASSURE WCD Clinical Evaluation - Conversion Efficacy Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'laura.gustavson@kestramedical.com', 'phone': '14255264759', 'title': 'Laura Gustavson', 'organization': 'Kestra Medical Technologies, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During the study procedure or observed during clinical follow-up within one week post procedure.', 'description': 'Adverse events in this study were limited to adverse device effects (ADEs). An ADE was defined as any untoward medical occurrence in a subject during the study that in the opinion of the investigator is at least possibly related to use of the Test System during the study procedure. Anticipated adverse device effects were specified in the study protocol based on risk assessment.', 'eventGroups': [{'id': 'EG000', 'title': 'Enrolled Subjects', 'description': 'Adult subjects who met eligibility criteria and provided written informed consent to participate\n\nDefibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system: defibrillation using a 170 joule biphasic truncated exponential waveform designed for the ASSURE wearable cardioverter defibrillator', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 3, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Redness/Irritation (Anticipated Adverse Device Effect)', 'notes': 'Mild skin irritation and redness in the location of the defibrillation pads within 48 hours following the procedure.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cumulative First and Second Shock VT/VF Conversion Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Per-Protocol', 'description': 'Adult subjects who met eligibility criteria and provided written informed consent to participate\n\nDefibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system: defibrillation using a 170 joule biphasic truncated exponential waveform designed for the ASSURE wearable cardioverter defibrillator'}, {'id': 'OG001', 'title': 'Intention-to-Treat', 'description': 'All subjects enrolled'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '73.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '75.3', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through study procedure completion, average of 2 hours', 'description': 'The number of subjects with successful (first or second shock) arrhythmia conversion using the Test System divided by the total number of inductions attempted using the Test System\n\nA successful arrhythmia conversion is defined as termination of an induced ventricular rhythm by first or second shock from the Test System to a non-shockable rhythm (rhythms other than VT or VF).', 'unitOfMeasure': 'percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'In consult with FDA, enrollment was halted due to the COVID pandemic after 13 subjects were enrolled. The study procedure was completed on all 13 subjects, which comprised the Intention-to-Treat cohort. Study monitoring identified one subject had been prescribed Amiodarone during an emergency room visit (three weeks prior to study enrollment) and continued taking it for 6 days (protocol eligibility deviation). Twelve patients were therefore included in the Per Protocol cohort.'}, {'type': 'SECONDARY', 'title': 'First Shock VT/VF Conversion Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Per-Protocol', 'description': 'Adult subjects who met eligibility criteria and provided written informed consent to participate\n\nDefibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system: defibrillation using a 170 joule biphasic truncated exponential waveform designed for the ASSURE wearable cardioverter defibrillator'}, {'id': 'OG001', 'title': 'Intention-to-Treat', 'description': 'All subjects enrolled'}], 'classes': [{'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '51.6', 'upperLimit': '97.9'}, {'value': '84.6', 'groupId': 'OG001', 'lowerLimit': '54.6', 'upperLimit': '98.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through study procedure completion, average of 2 hours', 'description': 'The number of subjects with successful (first shock) arrhythmia conversion using the Test System divided by the total number of inductions attempted with using the Test System\n\nA successful arrhythmia conversion is defined as termination of an induced ventricular rhythm by first shock from the Test System to a non-shockable rhythm (rhythms other than VT or VF).', 'unitOfMeasure': 'percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'In consult with FDA, enrollment was halted due to the COVID pandemic after 13 subjects were enrolled. The study procedure was completed on all 13 subjects, which comprised the Intention-to-Treat cohort. Study monitoring identified one subject had been prescribed Amiodarone during an emergency room visit (three weeks prior to study enrollment) and continued taking it for 6 days (protocol eligibility deviation). Twelve patients were therefore included in the Per Protocol cohort.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enrolled Subjects', 'description': 'Adult subjects who met eligibility criteria and provided written informed consent to participate\n\nDefibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system: defibrillation using a 170 joule biphasic truncated exponential waveform designed for the ASSURE wearable cardioverter defibrillator'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Thirteen (13) patients were enrolled at two investigational sites between November 25, 2019 and March 19, 2020. In consult with the FDA, enrollment was stopped short of the target enrollment of 20 patients due to the COVID-19 outbreak.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Enrolled Subjects', 'description': 'Adult subjects who met eligibility criteria and provided written informed consent to participate\n\nDefibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system: defibrillation using a 170 joule biphasic truncated exponential waveform designed for the ASSURE wearable cardioverter defibrillator'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.3', 'spread': '11.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-04', 'size': 1178425, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-06T16:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Multicenter single arm open label'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'dispFirstSubmitDate': '2020-09-01', 'completionDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-03', 'studyFirstSubmitDate': '2019-10-15', 'resultsFirstSubmitDate': '2024-03-07', 'studyFirstSubmitQcDate': '2019-10-16', 'dispFirstPostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-03', 'studyFirstPostDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative First and Second Shock VT/VF Conversion Rate', 'timeFrame': 'Through study procedure completion, average of 2 hours', 'description': 'The number of subjects with successful (first or second shock) arrhythmia conversion using the Test System divided by the total number of inductions attempted using the Test System\n\nA successful arrhythmia conversion is defined as termination of an induced ventricular rhythm by first or second shock from the Test System to a non-shockable rhythm (rhythms other than VT or VF).'}], 'secondaryOutcomes': [{'measure': 'First Shock VT/VF Conversion Rate', 'timeFrame': 'Through study procedure completion, average of 2 hours', 'description': 'The number of subjects with successful (first shock) arrhythmia conversion using the Test System divided by the total number of inductions attempted with using the Test System\n\nA successful arrhythmia conversion is defined as termination of an induced ventricular rhythm by first shock from the Test System to a non-shockable rhythm (rhythms other than VT or VF).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Death, Sudden, Cardiac']}, 'referencesModule': {'references': [{'pmid': '36917566', 'type': 'RESULT', 'citation': 'Gleva MJ, Sullivan J, Crawford TC, Walcott G, Birgersdotter-Green U, Branch KR, Doshi RN, Kivilaid K, Brennan K, Rowbotham RK, Gustavson LM, Poole JE. Defibrillation effectiveness and safety of the shock waveform used in a contemporary wearable cardioverter defibrillator: Results from animal and human studies. PLoS One. 2023 Mar 14;18(3):e0281340. doi: 10.1371/journal.pone.0281340. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'A multicenter single arm open label evaluation of the ASSURE Wearable Cardioverter Defibrillator (WCD) defibrillation waveform in adult cardiac patients', 'detailedDescription': 'The objective of this study is to evaluate Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) conversion efficacy in adult human subjects using the ASSURE Wearable Cardioverter Defibrillator (WCD) defibrillation waveform.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males or females, age ≥ 18 years\n2. Able and willing to provide written informed consent before undergoing any study-related procedures\n3. Scheduled for any of the following procedures:\n\n 1. Electrophysiology study for induction of ventricular arrhythmias\n 2. Non-invasive electrophysiology testing using an existing implantable defibrillator\n 3. Implantable cardioverter-defibrillator (ICD) replacement procedure during which induction of a ventricular arrhythmia is planned\n 4. Ablation of ventricular tachycardia (patients undergoing ventricular tachycardia ablation in which only a substrate modification approach is planned, with no intention of inducing a ventricular arrhythmia, should not be included)\n\nExclusion Criteria:\n\n1. Any condition that by the judgement of the physician investigator precludes the subject's ability to comply with the study requirements\n2. Pregnancy\n3. Use of mechanical circulatory support (e.g. Left Ventricular Assist Device, Total Artificial Heart, intraaortic balloon pump or Impella)\n4. Documented nonchronic cardiac thrombus\n5. Atrial fibrillation or atrial flutter without therapeutic systemic anticoagulation\n6. Critical aortic stenosis\n7. Unstable coronary artery disease (CAD)\n8. Recent stroke or transient ischemic attack (TIA)\n9. Hemodynamic instability\n10. Currently implanted Boston Scientific S-ICD (due to location of implant relative to test system)\n11. Unstable angina\n12. New York Heart Association (NYHA) Class IV\n13. Left Ventricular Ejection Fraction (LVEF) \\< 20%\n14. Any medical condition that by the judgement of the physician investigator, patient participation in this study is not in the best interest of the patient\n15. History of difficulty of ventricular arrhythmia induction\n16. Amiodarone use within 3 months before the study procedure"}, 'identificationModule': {'nctId': 'NCT04132466', 'acronym': 'ACE-CONVERT', 'briefTitle': 'ASSURE WCD Clinical Evaluation - Conversion Efficacy Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kestra Medical Technologies, Inc.'}, 'officialTitle': 'ASSURE WCD Clinical Evaluation - Conversion Efficacy Study (ACE-CONVERT)', 'orgStudyIdInfo': {'id': '3333934_C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enrolled Subjects', 'description': 'Adult subjects who met eligibility criteria and provided written informed consent to participate', 'interventionNames': ['Device: Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system']}], 'interventions': [{'name': 'Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system', 'type': 'DEVICE', 'description': 'defibrillation using a 170 joule biphasic truncated exponential waveform designed for the ASSURE wearable cardioverter defibrillator', 'armGroupLabels': ['Enrolled Subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Cardiovascular Research Foundation, Inc.', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University St Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Institute for Research and Innovation MultiCare Health System', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'Marye Gleva, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kestra Medical Technologies, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Regulatory and Clinical Research Institute Inc', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}