Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-27 @ 12:59 PM
Study NCT ID:
NCT04250857
Status:
RECRUITING
Last Update Posted:
2025-02-26
First Post:
2019-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HeartStart FRx Defibrillator Event Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1400}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2019-12-18', 'studyFirstSubmitQcDate': '2020-01-30', 'lastUpdatePostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Algorithm accuracy', 'timeFrame': 'Up to 15 minutes after device placement', 'description': 'Algorithm performance as determined by adjudication of the wave form data as aligned with the device advisement.'}, {'measure': 'Shock Delivery', 'timeFrame': '1 day', 'description': 'Percentage of events where a shock was delivered when indicated.'}, {'measure': 'Unexpected adverse events.', 'timeFrame': '1 day', 'description': 'Frequency and severity of unexpected adverse events.'}, {'measure': 'Unanticipated adverse device effects (UADE)', 'timeFrame': '1 day', 'description': 'Unanticipated adverse device effects (UADE)'}], 'secondaryOutcomes': [{'measure': 'Time Intervals', 'timeFrame': '1 day', 'description': 'Measurements of device performance time intervals.'}, {'measure': 'Device Preparation', 'timeFrame': '1 day', 'description': 'Percentage of events where the device prepared to shock.'}, {'measure': 'Shock Energy Delivered', 'timeFrame': '1 day', 'description': 'The amount of shock energy delivered as measured in joules with each shock.'}, {'measure': 'Pad Replacement', 'timeFrame': '1 day', 'description': 'Frequency of pad replacement.'}, {'measure': 'User', 'timeFrame': '1 day', 'description': 'Frequency of user pressing the shock button.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Sudden Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'This post market clinical follow-up study is a multi-center, non-randomized, unblinded, observational registry of the performance of the FRx Automated external defibrillator (AED) used in conjunction with electrodes with or without use of the infant/child key. The registry is focused only on on post-event data collection and does not prescribe any device usage. This registry has several safeguards in place to prevent against selections bias, including enrollment of all participants who have pads placed. This registry will evaluate the safety and verify the clinical performance of the device in relation to its claims, when used in accordance with the Device Manual.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Use of the HeartStart FRx AED is intended for the following populations in addition to adults: newborns, neonates, infant, children, and adolescents. It may also be used on pregnant women. Devices are located in public access spaces and with first responders around the world.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects accepted into the study must: have been suspected of a circulatory arrest for any cause\n* Have had HeartStart FRx AED with electrodes: HeartStart SMART PADS II applied to their body and powered up, regardless of whether a defibrillation shock was delivered\n\nExclusion Criteria:\n\n* AED or pad use other than the HeartStart FRx AED with electrodes : HeartStart SMART PADS II\n* AED used for training purposes.'}, 'identificationModule': {'nctId': 'NCT04250857', 'briefTitle': 'HeartStart FRx Defibrillator Event Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philips Clinical & Medical Affairs Global'}, 'officialTitle': 'HeartStart FRx Defibrillator Event Registry', 'orgStudyIdInfo': {'id': 'MATC-ECR-Registry-2018-10295'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Suspected Sudden Cardiac Arrest', 'description': 'All subject with suspected of a circulatory arrest for any cause.', 'interventionNames': ['Device: HeartStart FRX']}], 'interventions': [{'name': 'HeartStart FRX', 'type': 'DEVICE', 'description': 'Automated External Defibrillator', 'armGroupLabels': ['Suspected Sudden Cardiac Arrest']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15146', 'city': 'Monroeville', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Barb Fink', 'role': 'CONTACT', 'email': 'barb.fink@philips.com', 'phone': '724-708-7048'}, {'name': 'Gerrit Noordergraaf, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Philips', 'geoPoint': {'lat': 40.42118, 'lon': -79.7881}}], 'centralContacts': [{'name': 'Barb Fink', 'role': 'CONTACT', 'email': 'barb.fink@philips.com', 'phone': '724-708-7048'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philips Clinical & Medical Affairs Global', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}