Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-26 @ 1:42 AM
Study NCT ID:
NCT07158333
Status:
COMPLETED
Last Update Posted:
2025-11-12
First Post:
2025-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mobile Cardiac Telemetry (MCT) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-10', 'studyFirstSubmitDate': '2025-08-28', 'studyFirstSubmitQcDate': '2025-08-28', 'lastUpdatePostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative wear time', 'timeFrame': '30 days', 'description': 'as measured by ECG readability sufficient for identification of the P and QRS waves; the total readable duration summed from each patch, measured from the start of the first day to the end'}], 'secondaryOutcomes': [{'measure': 'Subject Self-Reported Log & Subject Survey of the MCT Patch after 30 days', 'timeFrame': '30 days', 'description': 'skin and adhesive comfort, and device stability and skin contact'}, {'measure': 'Adverse events of relevance, including potential skin damage due to repeated removal and reapplication of the MCT Patch as determined by Investigator/designee from subject assessments including Subject Logs, Subject Surveys and photos.', 'timeFrame': 'From enrollment to end of study at 30 days.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': "This study will be a single center, single arm, open-label, prospective study to evaluate adhesive performance of the Bardy Diagnostics' (BardyDx) MCT Patch up to 30 days of wear."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 10 healthy evaluable subjects (wearing and returning the test article) consisting of at least 5 males and 5 females is the desired sample size.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nEach subject must meet the following criteria to be enrolled in this study:\n\n1. Subject is ≥18 years of age.\n2. Completes the consent process as required.\n3. Subject can speak and read English fluently.\n4. Subject is willing to allow shaving of device application area, as required.\n5. Subject is willing and able to take photos of the application area before, during, and immediately after wear of each Adhesive Patch\n\nExclusion Criteria:\n\n1. Unable to comply with the study protocol and instructions for wearing the MCT Patch for up to 30 days.\n2. Geographically located such that they cannot have the initial MCT Patch placed by PI or designee.\n3. Any breached or compromised skin, skin rash, irritation or infection over the sternum (prior to the initial application) as reported by the subject and/or observed by the PI during initial application.\n4. Had any sternal incision or wound within 3 months prior to the date of enrolment.\n5. Subjects with sensitive skin or known skin conditions, including known allergies.\n6. Subjects with scheduled cardioversion during the data collection period.\n7. Subjects with a scheduled electronic imaging (including magnetic resonance imaging) during the data collection period.\n8. Subject has known cardiac arrhythmia conditions (Note: The PI will assess the subject during initial screening. If an arrhythmia is discovered during the subject will be deemed ineligible for participation in the study).'}, 'identificationModule': {'nctId': 'NCT07158333', 'briefTitle': 'Mobile Cardiac Telemetry (MCT) Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Baxter Healthcare Corporation'}, 'officialTitle': 'Mobile Cardiac Telemetry (MCT) Study', 'orgStudyIdInfo': {'id': 'BXU607689'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MCT device subjects', 'description': 'All subjects are provided MCT system', 'interventionNames': ['Device: Mobile Cardiac Telemetry (MCT System)']}], 'interventions': [{'name': 'Mobile Cardiac Telemetry (MCT System)', 'type': 'DEVICE', 'description': 'MCT System without data transmission', 'armGroupLabels': ['MCT device subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92630', 'city': 'Lake Forest', 'state': 'California', 'country': 'United States', 'facility': 'Orange County Research Center', 'geoPoint': {'lat': 33.64697, 'lon': -117.68922}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}