Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-01-06 @ 8:26 PM
Study NCT ID:
NCT05201495
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2022-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Jewel IDE Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-08-28', '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': 'zubin@elementsci.com', 'phone': '(415) 872-6500', 'title': 'Chief Medical Officer', 'organization': 'Element Science, Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Prescription Period during which each patient wore the Jewel up to 180 days', 'description': 'Adverse Events (AEs) defined as any untoward medical occurrence in a subject during the study that in the opinion of the investigator was at least potentially related to use of the Jewel system.', 'eventGroups': [{'id': 'EG000', 'title': 'Study Arm', 'description': 'Multi-center, prospective, single arm study of the Jewel Patch-Wearable Cardioverter Defibrillator (P-WCD) System in adult subjects aged 18 years and above at high risk for Sudden Cardiac Arrest, who were not candidates for or who refused an implanted cardioverter defibrillator.', 'otherNumAtRisk': 314, 'deathsNumAtRisk': 314, 'otherNumAffected': 49, 'seriousNumAtRisk': 314, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 51, 'numAffected': 49}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Inappropriate Shock Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Arm', 'description': 'Multi-center, prospective, single arm study of the Jewel Patch-Wearable Cardioverter Defibrillator (P-WCD) System in adult subjects aged 18 years and above at high risk for Sudden Cardiac Arrest, who were not candidates for or who refused an implanted cardioverter defibrillator.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.333', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Prescription Period during which each patient wore the Jewel up to 180 days.', 'description': 'Inappropriate shocks no more than 2.0 inappropriate shocks per 100 patient-months.', 'unitOfMeasure': 'inappropriate shocks per 100 pt-months', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 314 total patients completed, the primary analysis population was comprised of the 300 subjects who completed the study and had available device data contributing to analyzable wear time.'}, {'type': 'PRIMARY', 'title': 'Cutaneous Adverse Device Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Arm', 'description': 'Multi-center, prospective, single arm study of the Jewel Patch-Wearable Cardioverter Defibrillator (P-WCD) System in adult subjects aged 18 years and above at high risk for Sudden Cardiac Arrest, who were not candidates for or who refused an implanted cardioverter defibrillator.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.23', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Prescription Period during which each patient wore the Jewel up to 180 days.', 'description': 'Rate of subjects experiencing clinically significant cutaneous Adverse Device Effects of \\< 15%', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': 'Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)\n\nJewel Patch Wearable Cardioverter Defibrillator (P-WCD): Automatic external cardioverter defibrillator that monitors patients at risk for SCA and provides a therapeutic shock if needed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '322'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '314'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Arm', 'description': 'Multi-center, prospective, single arm study of the Jewel Patch-Wearable Cardioverter Defibrillator (P-WCD) System in adult subjects aged 18 years and above at high risk for Sudden Cardiac Arrest, who were not candidates for or who refused an implanted cardioverter defibrillator.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.8', 'spread': '13.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '94', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '220', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '302', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '30.0', 'spread': '6.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-22', 'size': 1425341, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-09T19:01', 'hasProtocol': True}, {'date': '2022-12-22', 'size': 1283657, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-07-09T19:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 322}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-25', 'studyFirstSubmitDate': '2022-01-05', 'resultsFirstSubmitDate': '2024-08-01', 'studyFirstSubmitQcDate': '2022-01-07', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-25', 'studyFirstPostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inappropriate Shock Rate', 'timeFrame': 'Prescription Period during which each patient wore the Jewel up to 180 days.', 'description': 'Inappropriate shocks no more than 2.0 inappropriate shocks per 100 patient-months.'}, {'measure': 'Cutaneous Adverse Device Effects', 'timeFrame': 'Prescription Period during which each patient wore the Jewel up to 180 days.', 'description': 'Rate of subjects experiencing clinically significant cutaneous Adverse Device Effects of \\< 15%'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Sudden Cardiac Arrest']}, 'referencesModule': {'references': [{'pmid': '39084827', 'type': 'DERIVED', 'citation': 'Hummel J, Houmsse M, Tomassoni G, Nair D, Romero J, Hargrove J, Mathews K, Thakkar AB, Ullery S, Eapen ZJ, Kumar UN, Mehran R, Butler J; Jewel IDE Study Investigators. A Patch Wearable Cardioverter-Defibrillator for Patients at Risk of Sudden Cardiac Arrest. J Am Coll Cardiol. 2024 Aug 6;84(6):525-536. doi: 10.1016/j.jacc.2024.04.063.'}]}, 'descriptionModule': {'briefSummary': 'The Jewel IDE Study: A Clinical Evaluation of the Jewel P-WCD in Subjects at High Risk for Sudden Cardiac Arrest. ("JEWEL")', 'detailedDescription': 'Multi-center, prospective, single arm study of the Jewel Patch-Wearable Cardioverter Defibrillator (P-WCD) System in patients at high risk for Sudden Cardiac Arrest'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients of any gender aged ≥ 18 years.\n2. Patients with either:\n\n 1. a measured LVEF less than or equal to 40% (as assessed by techniques such as, but not limited to, cardiac angiography, echocardiography, magnetic resonance imaging, or radionuclide angiography within the last 30 days prior to enrollment) AND identified as presenting with a diagnosis of an AMI, ischemic cardiomyopathy (includes congestive heart failure: NYHA Class I - III), non- ischemic cardiomyopathy, or myocarditis;\n\n OR\n 2. who have a temporary or long-term contraindication to receiving an ICD, who have had an ICD removed, or who refuse an ICD\n\n OR\n 3. whose ICD implantation is delayed due to COVID-19 infection or exposure- related risks\n\nExclusion Criteria:\n\n1. Member of a vulnerable patient population as defined in ISO 14155;\n2. Life expectancy of less than one year, including end-stage heart failure, cancer, or other diagnosed condition;\n3. Patients with an anticipated initial prescription period over 180 days (limitation only to allow timely closure of this clinical trial);\n4. Patients with an advanced directive prohibiting resuscitation;\n5. Existing ICD;\n6. Existing unipolar pacemaker;\n7. Existing FDA-cleared or FDA-approved active implantable or body worn medical device(s) that the Sponsor requires to be removed prior to the study but which cannot be removed;\n8. Clinically significant valve disease, including aortic stenosis, mitral stenosis; mitral regurgitation, tricuspid regurgitation, insufficiency of the aortic or pulmonary valves, any of which is likely to require surgery in the next year;\n9. A planned procedure, such as Coronary Artery Bypass Graft, within six (6) months;\n10. End-stage renal disease, or chronic renal failure requiring hemodialysis;\n11. Planned discharge to an institutional setting with an anticipated stay of greater than seven (7) days;\n12. Having a mental, visual, physical, or auditory deficit, that could impair their ability to properly place, remove, or interact with the Jewel System;\n13. Unable to understand English for the purposes of interacting with the device;\n14. Unable to use a wearable defibrillator due to physical conditions (bandages preventing electrode contact, physical deformities preventing electrode contact, etc.);\n15. Dextrocardia;\n16. Body circumference of less than 27 inches or greater than 56 inches in the intended area of the Belt component of the Placement Accessory;\n17. Participation in an investigational study of a drug, biologic, or device not currently approved for marketing;\n18. Allergic to or have had a known adverse reaction to medical adhesives or hydrocolloids;\n19. Active skin breakdown, erythema, or other signs of infection in the pectoral or torso regions where the Adhesive Electrode Patches are applied;\n20. Females who are pregnant or breast-feeding, or planning to be pregnant in the next 12 months;\n21. No US-based postal address that can be used to ship and receive study devices and supplies (a Post Office box is not an acceptable address for product shipments).\n22. Patients who, in the opinion of the Investigator, are anticipated to be non-compliant with study instructions;\n23. Unable to provide or have diminished capacity to provide informed consent;\n24. Any condition that an Investigator believes would interfere with the intent of the study or make participation not in the best interest of the patient.'}, 'identificationModule': {'nctId': 'NCT05201495', 'briefTitle': 'The Jewel IDE Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Element Science, Inc.'}, 'officialTitle': 'A Clinical Evaluation of the Jewel P-WCD in Subjects at High Risk for Sudden Cardiac Arrest', 'orgStudyIdInfo': {'id': 'PR-2053'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)', 'interventionNames': ['Device: Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)']}], 'interventions': [{'name': 'Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)', 'type': 'DEVICE', 'description': 'Automatic external cardioverter defibrillator that monitors patients at risk for SCA and provides a therapeutic shock if needed.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': "St. Bernard's Heart and Vascular", 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '72204', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Cardiology and Medicine Clinic, P.A.', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Georgetown University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Fuqua Heart Center Piedmont Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore Medical Group', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '46845', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Parkview Research Center', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '52246', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Central Baptist Hospital', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '38801', 'city': 'Tupelo', 'state': 'Mississippi', 'country': 'United States', 'facility': 'North Mississippi Medical Center', 'geoPoint': {'lat': 34.25807, 'lon': -88.70464}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 37.38227, 'lon': -89.66621}}, {'zip': '11215', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'New York Presbyterian Brooklyn Methodist Hospital', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '10941', 'city': 'Middletown', 'state': 'New York', 'country': 'United States', 'facility': 'Crystal Run Healthcare - Circuit - PPDS', 'geoPoint': {'lat': 41.44593, 'lon': -74.42293}}, {'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novant Health', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'TriHealth Heart Institute Cardiac and Thoracic', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Methodist Le Bonheur', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Saint Thomas Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75071', 'city': 'McKinney', 'state': 'Texas', 'country': 'United States', 'facility': 'ACRC Trials - Hunt - PPDS', 'geoPoint': {'lat': 33.19762, 'lon': -96.61527}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Fairfax Hospital', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'zip': '23225', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Cardiovascular Specialists', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Javed Butler, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Mississippi Medical Center'}, {'name': 'John Hummel, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}, {'name': 'Roxana Mehran, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Element Science, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}