Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-25 @ 5:17 PM
Study NCT ID:
NCT05135403
Status:
RECRUITING
Last Update Posted:
2025-09-02
First Post:
2021-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004554', 'term': 'Electric Countershock'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5179}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2021-08-30', 'studyFirstSubmitQcDate': '2021-11-24', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Appropriate shock rate per month', 'timeFrame': 'Up to 3 years', 'description': 'Number of appropriate shocks/cumulative months of WCD use'}, {'measure': 'Appropriate shock rate', 'timeFrame': 'Up to 3 years', 'description': 'Percent of patients who experience at least one appropriate shock'}, {'measure': 'Total Shocks delivered', 'timeFrame': 'Up to 3 years', 'description': 'Number of shocks delivered'}, {'measure': 'Shocks diverted', 'timeFrame': 'Up to 3 years', 'description': 'Number of shocks diverted by patients'}, {'measure': 'False positive shock alarm rate', 'timeFrame': 'Up to 3 years', 'description': 'Number of false positive shock alarms/cumulative WCD use'}, {'measure': 'True positive shock alarm rate', 'timeFrame': 'Up to 3 years', 'description': 'Number of true positive shock alarms/cumulative WCD use'}, {'measure': 'Adverse events', 'timeFrame': 'Up to 3 years', 'description': 'Adverse events related to use of the WCD'}, {'measure': 'Average daily device use', 'timeFrame': 'Up to 3 years', 'description': 'Average daily use of the WCD in hours per day'}, {'measure': 'Cumulative device use', 'timeFrame': 'Up to 3 years', 'description': 'Cumulative device use in days'}], 'primaryOutcomes': [{'measure': 'Overall shock conversion rate', 'timeFrame': 'Up to 3 years', 'description': 'Percent of spontaneous episodes of ventricular tachycardia/ventricular fibrillation (VT/VF) successfully converted with one or more shocks ≥ 89.0%'}, {'measure': 'Inappropriate shocks per patient month', 'timeFrame': 'Up to 3 years', 'description': 'Total inappropriate shocks/cumulative months of WCD use for all patients ≤ 0.0075'}], 'secondaryOutcomes': [{'measure': 'First shock conversion rate', 'timeFrame': 'Up to 3 years', 'description': 'Percent of spontaneous episodes of ventricular tachycardia/ventricular fibrillation (VT/VF) converted with a single shock. (report only)'}, {'measure': 'Inappropriate shock rate', 'timeFrame': 'Up to 3 years', 'description': 'Percent of patients who experience at least one inappropriate shock (report only)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Sudden Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'Active surveillance study using real-world data collected in the ASSURE Patient Registry. Outcome measures are based on analysis of ASSURE Registry data including data recorded by the WCD then annotated by clinical experts in electrophysiology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The ASSURE Wearable Cardioverter Defibrillator (WCD) system is indicated for adult patients who are at risk or at perceived risk of sudden cardiac arrest (SCA) and are not immediate candidates for, or refuse, an implantable defibrillator.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient prescribed the ASSURE wearable cardioverter defibrillator\n* Provided written informed consent to participate in the ASSURE Patient Registry\n\nExclusion Criteria:\n\n* Patients who do not meet the Inclusion criteria'}, 'identificationModule': {'nctId': 'NCT05135403', 'acronym': 'ACE-PAS', 'briefTitle': 'ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kestra Medical Technologies, Inc.'}, 'officialTitle': 'ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)', 'orgStudyIdInfo': {'id': 'DHF-00187-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ASSURE Registry Patients', 'description': 'Patient prescribed the ASSURE WCD who have also consented to participate in the ASSURE Patient Registry. Patients include those with reduced left ventricular ejection fraction (LVEF) and recent myocardial infarction, recent coronary revascularization, or new onset heart failure (HF) to allow for optimization of medical therapy and re-evaluation of cardiac function. Additional indications include ICD explant due to infection, postponed ICD implant, and pending heart transplant.', 'interventionNames': ['Device: Defibrillation']}], 'interventions': [{'name': 'Defibrillation', 'type': 'DEVICE', 'description': 'External defibrillation from a wearable cardioverter defibrillator', 'armGroupLabels': ['ASSURE Registry Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98033', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kristin Eis, BSChE, MBA', 'role': 'CONTACT', 'email': 'kristin.eis@kestramedical.com', 'phone': '12069636044'}], 'facility': 'University of Washington Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Kristin Eis, BSChE, MBA', 'role': 'CONTACT', 'email': 'kristin.eis@kestramedical.com', 'phone': '14256547596'}], 'overallOfficials': [{'name': 'Jeanne Poole, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kestra Medical Technologies, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}