Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2025-12-27 @ 4:08 PM
Study NCT ID:
NCT04559061
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2020-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vektor vMap™ Clinical Validation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-01-31', 'releaseDate': '2021-11-23'}, {'resetDate': '2023-08-30', 'releaseDate': '2022-10-17'}], 'estimatedResultsFirstSubmitDate': '2021-11-23'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D017180', 'term': 'Tachycardia, Ventricular'}, {'id': 'D014693', 'term': 'Ventricular Fibrillation'}, {'id': 'D018880', 'term': 'Atrial Premature Complexes'}, {'id': 'D013611', 'term': 'Tachycardia, Atrioventricular Nodal Reentry'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D005117', 'term': 'Cardiac Complexes, Premature'}, {'id': 'D054139', 'term': 'Tachycardia, Reciprocating'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 225}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-07', 'studyFirstSubmitDate': '2020-09-10', 'studyFirstSubmitQcDate': '2020-09-21', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of accuracy/agreement of vMap™ in correctly identifying the ventricular chamber/region of the arrhythmia for PCV and VT.', 'timeFrame': 'Immediately post ablation procedure through approximately 6 months post ablation procedure, based on retrospective data collection eligibility criteria.'}], 'secondaryOutcomes': [{'measure': 'Rate of accuracy/agreement of vMap™ in correctly identifying the chamber/region of the arrhythmia location for all arrhythmia types.', 'timeFrame': 'Immediately post ablation procedure through approximately 6 months post ablation procedure, based on retrospective data collection eligibility criteria.'}, {'measure': 'Rate of accuracy/agreement of vMap™ in correctly identifying the segment of the arrhythmia treatment across all arrhythmia types.', 'timeFrame': 'Immediately post ablation procedure through approximately 6 months post ablation procedure, based on retrospective data collection eligibility criteria.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cardiac Arrhythmia', 'Atrial Fibrillation', 'Ventricular Arrythmia', 'Premature Ventricular Complexes Multiple', 'Ventricular Tachycardia', 'Ventricular Fibrillation', 'Premature Atrial Complex', 'Atrioventricular Reentrant Tachycardia']}, 'referencesModule': {'references': [{'pmid': '36069189', 'type': 'DERIVED', 'citation': 'Krummen DE, Villongco CT, Ho G, Schricker AA, Field ME, Sung K, Kacena KA, Martinson MS, Hoffmayer KS, Hsu JC, Raissi F, Feld GK, McCulloch AD, Han FT. Forward-Solution Noninvasive Computational Arrhythmia Mapping: The VMAP Study. Circ Arrhythm Electrophysiol. 2022 Sep;15(9):e010857. doi: 10.1161/CIRCEP.122.010857. Epub 2022 Sep 7.'}]}, 'descriptionModule': {'briefSummary': 'This is a retrospective, multi center clinical study collecting existing, de-identified subject data from medical records to be analyzed using an independent core laboratory to validate performance of a computational ECG mapping system (vMap™).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '22 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with cardiac arrhythmia that have undergone successful ablation procedures.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient has one of the following clinical arrhythmia/pacing types:\n\n * Atrial pacing\n * Atrial fibrillation\n * Ventricular pacing\n * Premature ventricular complex\n * Ventricular tachycardia\n * Ventricular fibrillation\n * Focal atrial tachycardia\n * Premature atrial complex\n * Atrioventricular reentrant tachycardia\n2. Patient has undergone 'successful' routine, standard of care diagnostic electrophysiology (EP) study using intracardiac catheters as clinically indicated, guided by fluoroscopy and routine electroanatomic mapping, intracardiac echocardiography, and/or cardiac imaging such as CT or MRI.\n3. Patient has 12 lead electrogram data of clinical rhythms recorded on electrogram recording system.\n4. Patient has undergone a successful ablation procedure.\n5. Arrhythmia type and atrial/ventricular characteristics can be abstracted from patient medical records.\n6. Patient was between 22 and 100 years of age at time of EP study and ablation procedure.\n\nExclusion Criteria:\n\nPatients with unstable coronary artery disease, confirmed intracardiac thrombus, active sepsis, complex congenital heart disease, dextrocardia, severe pulmonary hypertension, decompensated heart failure, a mechanical heart valve, myocardial infarction within 1 month of ablation, inability to induce arrhythmia, unacceptable ECG data quality, and/or data included in the device training dataset."}, 'identificationModule': {'nctId': 'NCT04559061', 'briefTitle': 'Vektor vMap™ Clinical Validation Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vektor Medical'}, 'officialTitle': 'Clinical Validation of the Vektor Computational ECG Mapping System (vMap™) for Atrial and Ventricular Arrhythmias/Pacing', 'orgStudyIdInfo': {'id': '20-PR-1010'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cardiac ablation procedure', 'type': 'DEVICE', 'description': 'Retrospective data will be collected from cases where successful ablation was completed.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'California', 'country': 'United States', 'facility': 'Medical University of South Carolina'}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego Health', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'VA San Diego Healthcare System', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94107', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Health', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Chris Villongco, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Vektor Medical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vektor Medical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Experien Group', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-11-23', 'type': 'RELEASE'}, {'date': '2022-01-31', 'type': 'RESET'}, {'date': '2022-10-17', 'type': 'RELEASE'}, {'date': '2023-08-30', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Vektor Medical'}}}}