[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07158450":3,"trial-entities:NCT07158450":113,"trial-summary:NCT07158450":116},{"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":21,"study_type":22,"primary_purpose":17,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":28,"secondary_outcomes":33,"sex":37,"minimum_age":38,"maximum_age":17,"healthy_volunteers":39,"eligibility_criteria":40,"std_ages":48,"locations":51,"central_contacts":109,"overall_officials":110,"references":111,"see_also_links":112},"NCT07158450","SKR-LVEF-001","Novel On-body Evaluation of Cardiac Health for Oncology","Evaluation of Wearable Sensor-Based Estimation of Left Ventricular Ejection Fraction (LVEF) - Pilot Study","ENROLLING_BY_INVITATION","2026-09","2026-05","2026-05-20","2025-10-09","Skribe Medical","INDUSTRY",false,"The goal of this study is to develop a wearable sensor system that can estimate left ventricular ejection fraction (LVEF), which is a measurement of the heart's function.",null,[19,20],"Cardiotoxicity","Heart Failure",[],"OBSERVATIONAL",[],{"count":25,"type":26},500,"ESTIMATED",[],[29],{"measure":30,"description":31,"timeFrame":32},"Correlation between wearable-derived and transthoracic echocardiography-derived left ventricular ejection fraction estimates","The primary analysis will compute the correlation coefficient (r) between wearable-derived model estimates of LVEF and transthoracic echocardiography-derived LVEF in the Hold-Out Test Set. The prespecified performance target is r \\> 0.70.","From baseline through study completion (up to 6 months) at each paired assessment",[34],{"measure":35,"description":36,"timeFrame":32},"Clinical accuracy of wearable-derived LVEF compared with echocardiography","Proportion of predictions within ±5 percentage points of TTE-derived LVEF in the Hold-Out Test Set. Error metrics will be calculated as Mean Absolute Error (MAE) between wearable-derived and TTE-derived LVEF. Differences across subgroups will be tested with ANOVA or Kruskal-Wallis as appropriate. Prespecified performance target: MAE ≤ 5 percentage points.","ALL","18 Years",true,{"inclusion":41,"exclusion":44,"raw_text":47},[42,43],"Undergoing an echocardiogram irrespective of participation in this study","Willing and able to provide informed consent prior to any study-related activity",[45,46],"Have a documented allergy to potential tissue contacting system materials","Have any condition that would cause inaccurate TTE measurements","Inclusion Criteria:\n\n* Undergoing an echocardiogram irrespective of participation in this study\n* Willing and able to provide informed consent prior to any study-related activity\n\nExclusion Criteria:\n\n* Have a documented allergy to potential tissue contacting system materials\n* Have any condition that would cause inaccurate TTE measurements",[49,50],"ADULT","OLDER_ADULT",[52,61,69,77,85,93,101],{"facility":53,"city":54,"state":55,"zip":56,"country":57,"geoPoint":58},"Colorado Heart and Vascular","Golden","Colorado","80401","United States",{"lat":59,"lon":60},39.75554,-105.2211,{"facility":62,"city":63,"state":64,"zip":65,"country":57,"geoPoint":66},"Clearwater Cardiovascular Consultants","Clearwater","Florida","33756",{"lat":67,"lon":68},27.96585,-82.8001,{"facility":70,"city":71,"state":72,"zip":73,"country":57,"geoPoint":74},"Midwest Cardiovascular Institute","Naperville","Illinois","60540",{"lat":75,"lon":76},41.78586,-88.14729,{"facility":78,"city":79,"state":80,"zip":81,"country":57,"geoPoint":82},"Cardiovascular Institute of the South","Houma","Louisiana","70360",{"lat":83,"lon":84},29.59577,-90.71953,{"facility":86,"city":87,"state":88,"zip":89,"country":57,"geoPoint":90},"Strong Memorial Hospital","Rochester","New York","14642",{"lat":91,"lon":92},43.15478,-77.61556,{"facility":94,"city":95,"state":96,"zip":97,"country":57,"geoPoint":98},"Cardiology Consultants of Philadelphia","Yardley","Pennsylvania","19067",{"lat":99,"lon":100},40.24566,-74.846,{"facility":102,"city":103,"state":104,"zip":105,"country":57,"geoPoint":106},"Stern Cardiovascular Center","Germantown","Tennessee","38138",{"lat":107,"lon":108},35.08676,-89.81009,[],[],[],[],{"nct_id":4,"conditions":114,"biomarkers":115},[19,20],[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]