Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-01-05 @ 1:08 AM
Study NCT ID:
NCT02162394
Status:
COMPLETED
Last Update Posted:
2017-09-25
First Post:
2014-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Determine the Feasibility of Wireless Electrocardiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-20', 'studyFirstSubmitDate': '2014-06-10', 'studyFirstSubmitQcDate': '2014-06-11', 'lastUpdatePostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of 8 second ECG strips of sufficient quality for visual diagnosis', 'timeFrame': '3 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Atrial Fibrillation', 'Premature Atrial and Ventricular Beats', 'Conduction Defects', 'Normal Sinus Rhythm']}, 'descriptionModule': {'briefSummary': 'The investigators are conducting a prospective, observational study to examine the ECG waveforms captured by the new medical device as compared to a traditional Holter monitor for subsequent use in visual diagnoses of atrial and ventricular arrhythmias as well as cardiac impulse and/or conduction disorders by qualified clinicians.\n\nThe hypothesis is that this new medical device prototype is non-inferior to traditional Holter monitoring for capturing ECG waveforms that can be visually assessed for atrial and ventricular arrhythmias as well as disorders of cardiac impulse formation and/or conduction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects referred for 24 hour Holter monitoring', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be at least 18 years of age\n* Patients must have a medical indication to wear a Holter monitor\n* Patients must not be pregnant\n* Patients must be able to comply with the study procedures\n* Patients must be willing to participate and able to provide informed consent\n* Patients must be willing to wear both devices (Holter and the wireless device prototype) simultaneously and continuously for a 2 to 3 hr period\n\nExclusion Criteria:\n\n* Patients who are not able or willing to comply with study procedures\n* Patients with an existing implanted cardioverter-defibrillator and/or pacemaker\n* Patients with a known life threatening arrhythmia\n* Patients who manifest low voltage on their electrocardiogram\n* Patients affected by inflammatory and/or infectious skin disorders'}, 'identificationModule': {'nctId': 'NCT02162394', 'briefTitle': 'A Study to Determine the Feasibility of Wireless Electrocardiography', 'organization': {'class': 'INDUSTRY', 'fullName': 'Peerbridge Health, Inc'}, 'officialTitle': 'Study to Determine the Feasibility of Wireless Electrocardiography', 'orgStudyIdInfo': {'id': '14-022A'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Referred for Holter monitoring', 'interventionNames': ['Device: Observational ambulatory ECG monitoring']}], 'interventions': [{'name': 'Observational ambulatory ECG monitoring', 'type': 'DEVICE', 'armGroupLabels': ['Referred for Holter monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10075', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Lenox Hill Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peerbridge Health, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}