[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04636892":3,"trial-entities:NCT04636892":110,"trial-summary:NCT04636892":117},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":25,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":44,"secondary_outcomes":49,"sex":50,"minimum_age":51,"maximum_age":51,"healthy_volunteers":15,"eligibility_criteria":52,"std_ages":64,"locations":68,"central_contacts":93,"overall_officials":100,"references":102,"see_also_links":103},"NCT04636892","20-7677","Evaluating Infrasonic Hemodynography","Clinical Correlation of a Novel Wearable Sensor to Detect Cardiovascular Mechanical and Electrical Properties Through Infrasonic Hemodynography","UNKNOWN","2025-12-01","2024-04","2024-04-16","2021-01-04","Scripps Health","OTHER",false,"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.","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.",[19,20,21,22,23,24],"Aortic Stenosis","Mitral Regurgitation","Pulmonary Hypertension","Heart Failure, Systolic","Cardiovascular Diseases","Coronary Artery Disease",[26,27],"infrasonic hemodynography","biomedical device","INTERVENTIONAL","DIAGNOSTIC",[31],"NA",{"count":33,"type":34},25,"ESTIMATED",[36],{"type":14,"name":37,"description":38,"armGroupLabels":39},"MindMics earbud","Novel noninvasive wearable infrasound sensor",[40,21,41,42,43],"Heart Failure with Reduced EF \u003C35%","Severe aortic stenosis","Severe mitral regurgitation","Suspected coronary artery disease",[45],{"measure":46,"description":47,"timeFrame":48},"Infrasound Hemodynography","Correlation of Infrasound data to hemodynamic parameter(s) and to cardiac time intervals","1 year",[],"ALL",null,{"inclusion":53,"exclusion":56,"raw_text":63},[54,55],"Normal Sinus Rhythm","LV systolic function \\>53%",[57,58,59,60,61,62],"1\\. Known history of carotid artery disease","2\\. Moderate or greater valvular disease in Group 1","3\\. Other implantable devices (pacemaker, ICD, CardioMems, TENS unit, continuous glucose monitors, etc)","4\\. Active arrhythmia","5\\. Reduced Ejection Fraction (\\\u003C 35%) other than Group 4","6\\. Hearing loss","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 (\\\u003C 35%) other than Group 4\n* 6\\. Hearing loss",[65,66,67],"CHILD","ADULT","OLDER_ADULT",[69],{"facility":13,"status":70,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":90},"RECRUITING","La Jolla","California","92037","United States",[76,80,83,86,88],{"name":77,"role":78,"email":79},"Curtiss Stinis, MD","CONTACT","stinis.curtiss@scrippshealth.org",{"name":81,"role":78,"email":82},"Sanjeev Bhavnani, MD","bhavnani.sanjeev@scrippshealth.org",{"name":84,"role":85},"Steven Romero, MD","PRINCIPAL_INVESTIGATOR",{"name":81,"role":87},"SUB_INVESTIGATOR",{"name":89,"role":85},"Curtis Stinnis, MD",{"lat":91,"lon":92},32.84727,-117.2742,[94,98],{"name":95,"role":78,"phone":96,"email":97},"Carly Waldman, MD","858-537-7792","waldman.carly@scrippshealth.org",{"name":81,"role":78,"phone":99,"email":82},"619-660-1842",[101],{"name":81,"affiliation":13,"role":85},[],[104,107],{"label":105,"url":106},"Wearable PPG prediction of cardiac output from arterial line measurement in a swine model","https:\u002F\u002Fwww.nature.com\u002Farticles\u002Fs41598-020-74686-6",{"label":108,"url":109},"Hearables: Multimodal physiological in-ear sensing","https:\u002F\u002Fpubmed.ncbi.nlm.nih.gov\u002F28761162\u002F",{"nct_id":4,"conditions":111,"biomarkers":116},[112,113,24,114,115,21],"Aortic Valve Stenosis","Cardiovascular Disorder","Heart Failure","Mitral Valve Insufficiency",[],{"nct_id":4,"found":118,"summary":119,"prompt_version":129},true,{"design":120,"status":121,"heading":122,"summary":123,"follow_up":124,"word_count":125,"commitments":126,"compensation":127,"drugs_mentioned":128},"This is a comparative diagnostic accuracy study involving 25 participants. It is an interventional study, meaning participants will receive a specific intervention (wearing the earbud).","completed","Evaluating the MindMics Earbud for Heart Conditions","This study is testing a new device called the MindMics earbud. It's a noninvasive (doesn't go inside your body) wearable sensor that listens to very low-frequency sounds (infrasound) from your heart. Researchers want to see how accurately this earbud can detect how well your heart is working, especially if you have conditions like Aortic Stenosis, Mitral Regurgitation, Pulmonary Hypertension, or Heart Failure. You might be able to join if you have a normal heart rhythm and good left ventricle (main pumping chamber) function. The main goal is to see if the infrasound readings from the earbud match up with other heart tests after one year. The current status of this study is unclear.","Your infrasound hemodynography will be measured at 1 year.",113,"You would wear an infrasonic earbud device while undergoing a comprehensive echocardiogram (ultrasound of the heart), electrocardiogram (ECG, measures electrical activity of the heart), and cardiac catheterization (a procedure to look at the heart's blood vessels).","Not stated in the trial record.",[37],"v2"]