Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT03408951
Status:
COMPLETED
Last Update Posted:
2019-08-21
First Post:
2018-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surface ECG Signal Recording for the Implantable Subcutaneous String Defibrillator (ISSD) Detection Algorithm Performance Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-20', 'studyFirstSubmitDate': '2018-01-16', 'studyFirstSubmitQcDate': '2018-01-23', 'lastUpdatePostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ISSD algorithm detection rates', 'timeFrame': 'through study completion, expected at 15 months', 'description': 'Calculation of the ISSD algorithm detection and classification rates, compared to an EP expert analysis of the ECG traces'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tachyarrhythmia', 'Arrhythmias, Cardiac']}, 'descriptionModule': {'briefSummary': 'Recorded cutaneous ECG containing arrhythmia events are separately analysed by an expert Electrophysiologist and the ISSD detection algorithm, to allow assessment of the correct detection of tachyarrhythmia events and discrimination of supra-ventricular arrhythmia of the algorithm,m compared to the expert.', 'detailedDescription': 'cutaneous ECG electrodes positioned near the sternum and on the midaxillary line, at the approximate positions of the ISSD sense electrodes, are used to record patients undergoing Defibrillation Threshold (DFT) studies or Electrophysiology (EP) studies of different types. Two separate copies of the recordings undergo parallel and separate analysis: one is sent to an expert Electrophysiologist for determination and classification of arrhythmia events of at least 5 seconds and at least 170 beats per minute. the other is fed to the ISSD detection algorithm, with a low cutoff rate of 170 beats per minute. the results are compared to establish the accuracy of the detection algorithm and the rate of false detection / classification of arrhythmia events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with high chance of having a cardiac tachyarrhythmia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* candidate for ICD implantation\n* candidate for an ICD DFT study\n* candidate for an EP study\n\nExclusion Criteria:\n\n* age \\<18'}, 'identificationModule': {'nctId': 'NCT03408951', 'briefTitle': 'Surface ECG Signal Recording for the Implantable Subcutaneous String Defibrillator (ISSD) Detection Algorithm Performance Assessment', 'organization': {'class': 'INDUSTRY', 'fullName': 'NewPace Ltd'}, 'officialTitle': 'Surface ECG Signal Recording for the Implantable Subcutaneous String Defibrillator (ISSD) Detection Algorithm Performance Assessment', 'orgStudyIdInfo': {'id': 'NPC03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Interventions (recording)', 'description': 'Patients requiring Intracardiac defibrillator (ICD) implantation or Defibrillation Test (DFT) or Electrophysiology (EP) study with high probability of supra ventricular tachyarrhythmia.', 'interventionNames': ['Other: Recording']}], 'interventions': [{'name': 'Recording', 'type': 'OTHER', 'description': 'The patient cutaneous ECG is recorded, to later be comparatively analysed by an expert and by the ISSD detection algorithm', 'armGroupLabels': ['Interventions (recording)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11576', 'city': 'Roslyn', 'state': 'New York', 'country': 'United States', 'facility': 'St Francis Hospital Heart Center', 'geoPoint': {'lat': 40.79982, 'lon': -73.65096}}], 'overallOfficials': [{'name': 'Joseph H Levine, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St Francis Hospital Heart Center'}, {'name': 'David Hoch, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St Francis Hospital Heart Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NewPace Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}