Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-02-25 @ 5:45 PM
Study NCT ID:
NCT04202718
Status:
WITHDRAWN
Last Update Posted:
2020-06-24
First Post:
2019-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VitalConnect VitalPatch ECG Interpretation/Arrhythmia Detection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study never started due to COVID-19 pandemic', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-05-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-22', 'studyFirstSubmitDate': '2019-12-16', 'studyFirstSubmitQcDate': '2019-12-16', 'lastUpdatePostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in false alarms received from current telemetry monitoring technology', 'timeFrame': '6 months', 'description': '• Compare generation of false alarms with VitalPatch and current telemetry monitoring'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['ECG Interpretation'], 'conditions': ['Arrythmia, Cardiac']}, 'descriptionModule': {'briefSummary': 'Subjects in this study will wear the VitalPatch with the added ECG Interpretation and arrhythmia detection features which will expedite the identification of patients whose condition may rapidly deteriorate as well as eliminate the majority of non-actionable alarms.', 'detailedDescription': 'This project intends to validate, through comparative study, the output of new technologies (ECG Interpretation and arrhythmia detection) to the VistaCenter platform, aiming to replace current telemetry monitoring equipment. The new technology, through the previous Mercy pilot study, has demonstrated greater accuracy in the detection of ventricular tachycardia patterns and other dysrhythmias/arrhythmias, as well as, reducing the volume of false alarms resulting in the mitigation of alarm fatigue experienced by bedside staff and monitor technicians.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old,\n* No skin trauma to the site where the patch will be applied\n* No known allergies to hydrocolloid or silicone based adhesives\n* Admitted to Mercy Hospital Washington Cardiac Unit on the 5th floor and have been placed in one of the assigned rooms and require cardiac/telemetry monitoring as ordered by their physician\n\nExclusion Criteria:\n\n* Pacemaker or Implanted Defibrillator (ICD)\n* Pregnancy\n* Adults unable to provide informed consent\n* Individuals who cannot read and understand English\n* Prisoners\n* Not recommended for use in MRI'}, 'identificationModule': {'nctId': 'NCT04202718', 'briefTitle': 'VitalConnect VitalPatch ECG Interpretation/Arrhythmia Detection', 'organization': {'class': 'OTHER', 'fullName': 'Mercy Research'}, 'officialTitle': 'VitalConnect VitalPatch ECG Interpretation/Arrhythmia Detection', 'orgStudyIdInfo': {'id': '20-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single group', 'description': 'Where a wearable biosensor is being considered for use in the health management of individuals at high-risk for poor health outcomes, and in the detection or prevention of adverse events within settings where traditional monitoring devices are not currently in use, the ECG interpretation will provide Arrhythmia detection which will help ensure that irregular rhythms will be reported quickly.', 'interventionNames': ['Diagnostic Test: VitalPatch Device']}], 'interventions': [{'name': 'VitalPatch Device', 'type': 'DIAGNOSTIC_TEST', 'description': 'The VitalPatch® is an IRB (791130) and FDA approved wearable device that allows for the constant monitoring of biometric measurements and may have utility in the health management of individuals at high-risk for poor health outcomes and in the detection or prevention of adverse events within settings where more traditional telemetry monitoring devices are not currently in use.', 'armGroupLabels': ['Single group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63090', 'city': 'Washington', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mercy Hospital Washington', 'geoPoint': {'lat': 38.55811, 'lon': -91.01209}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mercy Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Ashok Palagiri', 'investigatorAffiliation': 'Mercy Research'}}}}