Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-29 @ 7:52 AM
Study NCT ID:
NCT04804969
Status:
UNKNOWN
Last Update Posted:
2023-09-21
First Post:
2021-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MyoVista wavECG Clinical Validation Study Versus Low e' on Echocardiogram
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 575}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-20', 'studyFirstSubmitDate': '2021-03-16', 'studyFirstSubmitQcDate': '2021-03-16', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and Specificity', 'timeFrame': 'Baseline', 'description': 'Sensitivity and specificity of the MyoVista for the classification of Low e\' from echocardiogram where a "positive" includes Positive and Highly Positive MyoVista Device outcomes.'}], 'secondaryOutcomes': [{'measure': 'Sensitivity and Specificity', 'timeFrame': 'Baseline', 'description': 'Sensitivity and specificity of the MyoVista for classification of Low e\' versus echocardiogram where a "positive" includes Borderline, Positive and Highly Positive MyoVista Device outcomes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Left Ventricular Diastolic Dysfunction', 'Electrocardiograph'], 'conditions': ['Cardiac Disease']}, 'descriptionModule': {'briefSummary': 'Clinical validation study of the MyoVista wavECG.', 'detailedDescription': 'This is a multi-center, non-interventional, single arm clinical study of the MyoVista wavECG for the detection of LV relaxation abnormalities. Study subjects will be drawn from patients who are at-risk for cardiac disease and who have been referred for 2D transthoracic echocardiogram.\n\nThe study will be conducted at a minimum of three investigational sites within the United States.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with risk factors for cardiac disease or suspected of having cardiac disease during clinical assessment and have been referred to the site for 2D transthoracic echocardiogram.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects with risk factors for cardiac disease or suspected of having cardiac disease during clinical assessment.\n* The subject provides written informed consent using an Informed Consent Form that is reviewed and approved by the site's Institutional Review Board (IRB).\n* Conventional ECG results show a sinus rhythm and no other contraindicated rhythm abnormalities (see exclusions below).\n* Subject is \\>/= 22 years of age\n\nExclusion Criteria:\n\n* The subject has current acute coronary syndrome, decompensated heart failure or stroke\n* The subject has received any prior cardiac interventions or surgical therapeutic procedures relating to cardiac abnormalities: valve replacement, pacemaker implantation, coronary artery bypass grafting (CABG), heart transplant, ablation, coronary stent placement, etc.\n* Conventional ECG results indicating a lack of sinus rhythm and/or any other contraindicated rhythm abnormalities, including: active atrial fibrillation or atrial flutter, left anterior fascicular block, left and/or right bundle branch block\n* The subject is pregnant at the time of the study testing\n* The subject has chest deformities that interfere with accurate measurement of ECG (either conventional or wavECG)\n* Subjects with central nervous system or musculoskeletal abnormalities that may interfere with accurate acquisition of ECG and/or echocardiogram measurements.\n* The subject is enrolled in another clinical study that may interfere with MyoVista or echocardiogram measurements. Exceptions to this may be approved by HeartSciences."}, 'identificationModule': {'nctId': 'NCT04804969', 'briefTitle': "MyoVista wavECG Clinical Validation Study Versus Low e' on Echocardiogram", 'organization': {'class': 'INDUSTRY', 'fullName': 'Heart Test Laboratories, Inc.'}, 'officialTitle': 'MyoVista wavECG Clinical Validation Study', 'orgStudyIdInfo': {'id': 'HS-CLINVAL-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'At Risk Echo Referrals', 'description': 'Study subjects will be drawn from patients who are at-risk for cardiac disease and who have been referred for 2D transthoracic echocardiogram as standard of care. All will receive a MyoVista wavECG test.', 'interventionNames': ['Device: MyoVista wavECG Test']}], 'interventions': [{'name': 'MyoVista wavECG Test', 'type': 'DEVICE', 'description': 'The MyoVista wavECG is a standard 12-Lead high-performance, multi-channel resting interpretive electrocardiograph providing both a Glasgow Interpretive Analysis and unique MyoVista wavECG Information.', 'armGroupLabels': ['At Risk Echo Referrals']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Memorial Hospital', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '19141', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Einstein Medical Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75204', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Partho Sengupta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Robert Wood Johnson University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heart Test Laboratories, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}