[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05262907":3,"trial-entities:NCT05262907":118,"trial-summary:NCT05262907":122},{"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":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":40,"secondary_outcomes":81,"sex":82,"minimum_age":83,"maximum_age":83,"healthy_volunteers":15,"eligibility_criteria":84,"std_ages":90,"locations":94,"central_contacts":108,"overall_officials":113,"references":116,"see_also_links":117},"NCT05262907","Pro00108548","Ventripoint Single Ventricle Study","Assessment of Ventricular Volumes and Function in Single Ventricle Patients Using Ventripoint 3D Echocardiography","RECRUITING","2027-08","2025-10","2025-10-23","2022-07-08","Duke University","OTHER",false,"This study will validate a coordinate-based 3-dimensional echocardiographic technique for the assessment of cardiac size and function in children and young adults with functional single ventricles.","The accuracy of current echocardiographic techniques for measuring ventricular size and function are limited by geometric assumptions, which are particularly problematic in malformed hearts or functional single ventricles, as well as the inability to visualize the entire heart at one time from a single imaging window, and higher heart rates degrading 3D imaging volume rates. This study will validate a coordinate-based 3-dimensional echocardiographic technique for the assessment of cardiac size and function in children and young adults with functional single ventricles, including a comparison to the gold standard of cardiac MRI.",[19,20],"Congenital Heart Disease","Single-ventricle",[],"INTERVENTIONAL","DIAGNOSTIC",[25],"NA",{"count":27,"type":28},100,"ESTIMATED",[30,35],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DEVICE","Transthoracic Echocardiogram or Cardiac MRI","Non-invasive imaging of the heart to evaluate structure and function.",[32],{"type":31,"name":36,"description":37,"armGroupLabels":38},"Ventripoint Echocardiogram","Non-invasive ultrasound of the heart to evaluate structure and function through 3D imaging.",[39],"Ventripoint 3D Echocardiogram",[41,45,47,50,53,55,57,60,63,66,69,72,75,78],{"measure":42,"description":43,"timeFrame":44},"Cardiac function of the right ventricle as measured by ejection fraction","Ejection Fraction (EF) is a measurement of the percentage of blood leaving your heart each time it squeezes (contracts)with each heart beat.","Day 1",{"measure":46,"description":43,"timeFrame":44},"Cardiac function of the left ventricle as measured by ejection fraction",{"measure":48,"description":49,"timeFrame":44},"Right ventricular dimension as measured by end diastolic volume","End Diastolic Volume (EDV) is the volume of blood in a ventricle at end load or filling in (diastole) or the amount of blood in the ventricles just before systole.",{"measure":51,"description":52,"timeFrame":44},"Right ventricular dimension as measured by end systolic volume","End Systolic Volume (ESV) is the volume of blood in a ventricle at the end of contraction, or systole, and the beginning of filling, or diastole.",{"measure":54,"description":49,"timeFrame":44},"Left Ventricular Dimension as measured by end diastolic volume",{"measure":56,"description":52,"timeFrame":44},"Left Ventricular Dimension as measured by end systolic volume",{"measure":58,"description":59,"timeFrame":44},"Left Ventricular Dimension as measured by end diastolic diameter","End Diastolic Diameter (EDD) is the diameter across the left ventricle of the heart at the end of diastole, that is, when the heart muscle is maximally relaxed, and usually corresponds to its largest diameter.",{"measure":61,"description":62,"timeFrame":44},"Left Ventricular Dimension as measured by end systolic diameter","End Systolic Diameter (ESD) is the diameter across the left ventricle of the heart at the end of systole, that is, when the heart muscle is maximally contracted, and usually corresponds to its smallest diameter.",{"measure":64,"description":65,"timeFrame":44},"Right Ventricular Function as measured by tricuspid annular plane systolic excursion","Tricuspid Annular Plane Systolic Excursion (TAPSE) is a measurement of the decent of the right ventricular base towards a relatively fixed apex.",{"measure":67,"description":68,"timeFrame":44},"Right Ventricular Function as measured by myocardial performance index","RV Myocardial Performance Index (MPI) is a measurement that incorporates tricuspid valve closure to opening time and right ventricular ejection time to evaluate efficiency of the ventricle.",{"measure":70,"description":71,"timeFrame":44},"Left Ventricular Function as measured by myocardial performance index","LV Myocardial Performance Index (MPI) is a measurement that incorporates mitral valve closure to opening time and left ventricular ejection time to evaluate efficiency of the ventricle.",{"measure":73,"description":74,"timeFrame":44},"Left Ventricular Function as measured by tissue doppler imaging","Tissue Doppler Imaging (TDI) a measurement of the velocity of myocardial motion.",{"measure":76,"description":77,"timeFrame":44},"Left ventricular function as measured by shortening fraction","Shortening fraction(SF) is a measurement of the percentage of change in left ventricular diameter during systole.",{"measure":79,"description":80,"timeFrame":44},"Presence of ventricular dysfunction as measured by strain","Strain is a measure of deformity in the muscle of the ventricle.",[],"ALL",null,{"inclusion":85,"exclusion":87,"raw_text":89},[86],"All patients with functional single ventricles will be included, regardless of age or surgical palliation stage, who have had or are having a clinically ordered transthoracic echocardiogram and\u002For cardiac MRI.",[88],"Patients with congenital heart disease other than functional single ventricles, patients with single ventricle physiology (but not single ventricle anatomy) following a biventricular conversion pathway, or patients unable to understand or consent in English will be excluded.","Inclusion Criteria:\n\n* All patients with functional single ventricles will be included, regardless of age or surgical palliation stage, who have had or are having a clinically ordered transthoracic echocardiogram and\u002For cardiac MRI.\n\nExclusion Criteria:\n\n* Patients with congenital heart disease other than functional single ventricles, patients with single ventricle physiology (but not single ventricle anatomy) following a biventricular conversion pathway, or patients unable to understand or consent in English will be excluded.",[91,92,93],"CHILD","ADULT","OLDER_ADULT",[95],{"facility":13,"status":8,"city":96,"state":97,"zip":98,"country":99,"contacts":100,"geoPoint":105},"Durham","North Carolina","27705","United States",[101],{"name":102,"role":103,"email":104},"Piers Barker, MD","CONTACT","piers.barker@duke.edu",{"lat":106,"lon":107},35.99403,-78.89862,[109],{"name":110,"role":103,"phone":111,"email":112},"Joan Wilson","999999999","joan.wilson@duke.edu",[114],{"name":102,"affiliation":13,"role":115},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":119,"biomarkers":121},[120],"Common Ventricle Disorder",[],{"nct_id":4,"found":123,"summary":124,"prompt_version":133},true,{"design":125,"status":126,"heading":6,"summary":127,"follow_up":128,"word_count":129,"commitments":130,"compensation":131,"drugs_mentioned":132},"This is an interventional study that plans to enroll 100 participants. It will compare a new 3D ultrasound technique to standard imaging methods.","completed","This study is looking at a new way to measure heart size and function in children and young adults who have a condition called functional single ventricle (a type of congenital heart disease where only one of the heart's two pumping chambers works effectively). It uses a special 3D ultrasound called Ventripoint Echocardiogram, which is a non-invasive way to look at your heart. Researchers want to see how accurate this new method is compared to standard imaging tests like a regular echocardiogram or a cardiac MRI. The main goal is to measure how well the heart's pumping chambers (right and left ventricles) are working and their size on the first day of the study. Anyone with a functional single ventricle, regardless of age or previous surgeries, who is already having a standard echocardiogram or cardiac MRI can join. The study is planning to enroll 100 participants, but its current status is unclear.","Cardiac function and ventricular dimension are measured on Day 1. No further follow-up is specified.",152,"You would undergo a Ventripoint Echocardiogram, which is a non-invasive ultrasound of the heart. This would be in addition to a clinically ordered transthoracic echocardiogram and\u002For cardiac MRI you are already having.","Not stated in the trial record.",[36],"v2"]