Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-02-25 @ 11:01 PM
Study NCT ID:
NCT04636892
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2020-11-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Infrasonic Hemodynography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D054143', 'term': 'Heart Failure, Systolic'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2020-11-15', 'studyFirstSubmitQcDate': '2020-11-15', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infrasound Hemodynography', 'timeFrame': '1 year', 'description': 'Correlation of Infrasound data to hemodynamic parameter(s) and to cardiac time intervals'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infrasonic hemodynography', 'biomedical device'], 'conditions': ['Aortic Stenosis', 'Mitral Regurgitation', 'Pulmonary Hypertension', 'Heart Failure, Systolic', 'Cardiovascular Diseases', 'Coronary Artery Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.nature.com/articles/s41598-020-74686-6', 'label': 'Wearable PPG prediction of cardiac output from arterial line measurement in a swine model'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/28761162/', 'label': 'Hearables: Multimodal physiological in-ear sensing'}]}, 'descriptionModule': {'briefSummary': 'This comparative diagnostic accuracy study will determine the accuracy of a noninvasive wearable infrasonic sensor to detect the mechanical, electrical, and hemodynamic function of the cardiovascular system.', 'detailedDescription': "This comparative diagnostic accuracy study will determine the accuracy of a noninvasive wearable infrasonic sensor to detect the mechanical, electrical, and hemodynamic function of the cardiovascular system. 25 patients with cardiovascular disease will undergo a comprehensive echocardiogram, electrocardiogram, and cardiac catheterization while wearing a infrasonic earbud device. The infrasonic and hemodynamic waveforms will be analyzed using machine learning with the goal of correlating infrasound data captured by the earbud to the patient's cardiovascular hemodynamics."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal Sinus Rhythm\n* LV systolic function \\>53%\n\nExclusion Criteria:\n\n* 1\\. Known history of carotid artery disease\n* 2\\. Moderate or greater valvular disease in Group 1\n* 3\\. Other implantable devices (pacemaker, ICD, CardioMems, TENS unit, continuous glucose monitors, etc)\n* 4\\. Active arrhythmia\n* 5\\. Reduced Ejection Fraction (\\< 35%) other than Group 4\n* 6\\. Hearing loss'}, 'identificationModule': {'nctId': 'NCT04636892', 'briefTitle': 'Evaluating Infrasonic Hemodynography', 'organization': {'class': 'OTHER', 'fullName': 'Scripps Health'}, 'officialTitle': 'Clinical Correlation of a Novel Wearable Sensor to Detect Cardiovascular Mechanical and Electrical Properties Through Infrasonic Hemodynography', 'orgStudyIdInfo': {'id': '20-7677'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Severe aortic stenosis', 'description': 'Patients with echocardiographic evidence of severe aortic stenosis as defined by:\n\nAortic Vmax ≥4 m/s or mean ΔP ≥40 mmHg AVA ≤1.0 cm2', 'interventionNames': ['Other: MindMics earbud']}, {'type': 'EXPERIMENTAL', 'label': 'Severe mitral regurgitation', 'description': 'Patients with echocardiographic evidence of severe mitral regurgitation as defined by:\n\n* Central jet MR \\>40% LA or holosystolic eccentric jet MR\n* Vena contracta ≥0.7 cm\n* Regurgitant volume ≥60 mL\n* Regurgitant fraction ≥50%\n* ERO ≥0.40 cm2\n* Angiographic grade 3 to 4+', 'interventionNames': ['Other: MindMics earbud']}, {'type': 'EXPERIMENTAL', 'label': 'Heart Failure with Reduced EF <35%', 'description': 'Patients with echocardiographic evidence of left ventricular ejection fraction of \\< or = to 35%', 'interventionNames': ['Other: MindMics earbud']}, {'type': 'EXPERIMENTAL', 'label': 'Pulmonary Hypertension', 'description': 'Patients with echocardiographic evidence of a mean pulmonary artery pressure (mPAP; supine and at rest) \\>20mmHg', 'interventionNames': ['Other: MindMics earbud']}, {'type': 'EXPERIMENTAL', 'label': 'Suspected coronary artery disease', 'description': 'Patients with plan to undergo elective left heart diagnostic catheterization for the assessment of coronary artery disease', 'interventionNames': ['Other: MindMics earbud']}], 'interventions': [{'name': 'MindMics earbud', 'type': 'OTHER', 'description': 'Novel noninvasive wearable infrasound sensor', 'armGroupLabels': ['Heart Failure with Reduced EF <35%', 'Pulmonary Hypertension', 'Severe aortic stenosis', 'Severe mitral regurgitation', 'Suspected coronary artery disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Curtiss Stinis, MD', 'role': 'CONTACT', 'email': 'stinis.curtiss@scrippshealth.org'}, {'name': 'Sanjeev Bhavnani, MD', 'role': 'CONTACT', 'email': 'bhavnani.sanjeev@scrippshealth.org'}, {'name': 'Steven Romero, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sanjeev Bhavnani, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Curtis Stinnis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Scripps Health', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'centralContacts': [{'name': 'Carly Waldman, MD', 'role': 'CONTACT', 'email': 'waldman.carly@scrippshealth.org', 'phone': '858-537-7792'}, {'name': 'Sanjeev Bhavnani, MD', 'role': 'CONTACT', 'email': 'bhavnani.sanjeev@scrippshealth.org', 'phone': '619-660-1842'}], 'overallOfficials': [{'name': 'Sanjeev Bhavnani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Scripps Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scripps Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sanjeev Bhavnani MD', 'investigatorAffiliation': 'Scripps Health'}}}}