Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-06 @ 9:38 AM
Study NCT ID:
NCT03367104
Status:
COMPLETED
Last Update Posted:
2021-09-23
First Post:
2017-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Narrow QRS HF Patients Assessed by ECG Belt
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-21', 'studyFirstSubmitDate': '2017-12-04', 'studyFirstSubmitQcDate': '2017-12-07', 'lastUpdatePostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Electrical dyssynchrony quantification', 'timeFrame': 'through acute study completion (~60 minutes)', 'description': 'Collect ECG data with ECG Belt'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Heart Failure', 'Cardiac Resynchronization Therapy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to quantitate electrical dyssynchrony in heart failure (HF) patients with a narrow QRS complexes (≤ 130 ms) using the ECG Belt. This is a pilot study that is designed to provide data that can be used in designing and implementing a prospective study of cardiac resynchronization therapy (CRT) in narrow QRS patients selected and optimized using the ECG Belt.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy subjects and those with heart failure (reduced ejection fraction) with QRS duration ≤ 130 ms.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject (or their legal guardian) must be willing to provide informed consent for their participation in the study\n* Subject ≥ 18 years old\n\nExclusion Criteria:\n\n* Subject has unhealed-open wounds on the torso and/or has a history of severe allergic reactions from ECG electrode gel\n* Subject is enrolled in a concurrent study that could confound the results of this study\n* Subject is pregnant'}, 'identificationModule': {'nctId': 'NCT03367104', 'briefTitle': 'Narrow QRS HF Patients Assessed by ECG Belt', 'organization': {'class': 'OTHER', 'fullName': 'Allina Health System'}, 'officialTitle': 'Electrical Dyssynchrony in Narrow QRS Heart Failure Patients as Assessed by the ECG Belt', 'orgStudyIdInfo': {'id': 'ERP 3771'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal healthy controls', 'interventionNames': ['Device: ECG Belt']}, {'label': 'Heart failure patients', 'interventionNames': ['Device: ECG Belt']}], 'interventions': [{'name': 'ECG Belt', 'type': 'DEVICE', 'description': 'Assess electrical dyssynchrony with an anterior-posterior body surface mapping system.', 'armGroupLabels': ['Heart failure patients', 'Normal healthy controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55102', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'United Heart & Vascular Clinic', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'overallOfficials': [{'name': 'Alan Bank, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Allina Health System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allina Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director of Research - UHVC', 'investigatorFullName': 'Alan J. Bank, MD', 'investigatorAffiliation': 'Allina Health System'}}}}