[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fetal-cardiac-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fetal-cardiac-disorder":39},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,68,96],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":43,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"100345304","fetal-electrophysiologic-abnormalities-in-high-risk-pregnancies-associated-with-fetal-demise-100345304",false,"NCT03775954","Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise","Fetal Electrophysiologic Abnormalities in High-risk Pregnancies Associated With Fetal Demise","Inclusion Criteria:\n\n* Current pregnancy complicated by one of the five diagnostic categories\n\n  * prior unexplained Stillbirth at\u002Fafter 20 weeks gestation\n  * fetal major congenital heart defect\n  * fetal hydrops\n  * fetal gastroschisis\n  * monochorionic twin pregnancy\n* Subject must be 18 years of age or older\n* Subject must be English speaking and must be able to read and sign the consent form in English\n* Subject must be able to recline comfortably for 1-3 hours\n* Subject must be willing to complete all three procedures (fMCG, fMCG, nECG) as per protocol, unless medically unable\n* Subject must be willing to allow us to review her and her infants prenatal, deliver, and post-natal records to verify diagnosis, and clinical findings.\n\nExclusion Criteria:\n\n* Severe claustrophobia not reduced by taking breaks, or by having the light on, or by having someone in the room with them.\n* Active labor\n* Acute illness\n* Unable to recline comfortably with a pillow for more than 1-3 hours (assuming some breaks are provided)\n* Weight over 450 lbs\n* An electric stimulation device (TENS unit, pacemaker, or nerve stimulator) that could produce electric or magnetic noise.\n\n  * Note that the Tristan 624 Magnetometer does not pose a risk to the subject's device, (since fMCG does not produce any energy or magnetism), but stimulators themselves can cause interference for our recordings. Some devices may still qualify, and discussion with study nurse may be useful if subject has a pacemaker or similar device.\n\nThe subject will have a single 2-3 hour fetal magnetocardiogram at approximately 20 and 27 weeks GA, and again, if medical condition allows, between 30 and 37 weeks GA, then her infant will have an ECG between 0 and 4 weeks of age. Subjects will be paid a nominal fee for their participation each time, as well as transportation reimbursement if \\>25 miles. For subjects traveling a long distance, the ECG may be performed locally or at home.","FEMALE","18 Years",{"count":19,"type":20},30,"ESTIMATED","OBSERVATIONAL","Each year world-wide, 2.5 million fetuses die unexpectedly in the last half of pregnancy, 25,000 in the United States, making fetal demise ten-times more common than Sudden Infant Death Syndrome. This study will apply a novel type of non-invasive monitoring, called fetal magnetocardiography (fMCG) used thus far to successfully evaluate fetal arrhythmias, in order to discover potential hidden electrophysiologic abnormalities that could lead to fetal demise in five high-risk pregnancy conditions associated with fetal demise.",[24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42],"High Risk Pregnancy","Congenital Heart Disease","Fetal Hydrops","Twin Monochorionic Monoamniotic Placenta","Gastroschisis","Fetal Demise","Stillbirth","Fetal Arrhythmia","Long QT Syndrome","Intrauterine Fetal Death","Sudden Infant Death","Pregnancy Loss","Twin Twin Transfusion Syndrome","Birth Defect","Fetal Cardiac Anomaly","Fetal Cardiac Disorder","Fetal Death","Brugada Syndrome","Fetal Tachycardia",[44,30,45,46,47,24,48,49,50,51,52,53,54],"Fetal Magnetocardiography","Intrauterine Fetal Demise","Fetal Heart Rate Variability","Fetal Arrhythmias","Pregnancy","Fetal Anomaly","Fetal Echocardiography","Non-Stress Testing","New Technology","Birth Defects","Fetal Research","RECRUITING","2026-03-02",{"date":58,"type":59},"2026-03-04","ACTUAL",{"date":61,"type":59},"2018-07-01",{"date":63,"type":20},"2028-11-30",{"name":65,"class":66},"Medical College of Wisconsin","OTHER",2,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":67},"100600310","prognostic-model-of-postnatal-circulation-in-pulmonary-atresia-critical-stenosis-with-intact-ventricular-septum-100600310","NCT07095829","Prognostic Model of Postnatal Circulation in Pulmonary Atresia-critical Stenosis With Intact Ventricular Septum","Development and Validation of a Prognostic Model of Postnatal Circulation in Fetuses With a Diagnosis of Pulmonary Atresia-critical Stenosis With Intact Ventricular Septum A Prospective Observational Cohort Study","Inclusion Criteria:\n\n* Absence of flow at the pulmonary valve (PA) or presence of thickened and domed. pulmonary valve cusps with a pinhole jet of flow.\n* Doppler evidence of ductal-dependent pulmonary circulation.\n* Intact ventricular septum.\n\nExclusion Criteria:\n\n* Poor imaging windows and incomplete\u002Fpoor quality scan\n* Termination of pregnancy\n* Cases initially included that undergo prenatal pulmonary valvuloplasty later on in pregnancy.\n* Unconfirmed PA-CS\u002FIVS at birth.\n* Functional PA-CS\u002FIVS (Ebstein malformation, monochorionic twins)\n* Any associated cardiac defect except persistent left superior vena cava and aberrant right subclavian artery.\n* Any significant (i.e that might influence outcome) extracardiac anomaly and\u002For known genetic syndromes. Also, if such a condition is present at inclusion but diagnosed only after birth, the case will be retrospectively excluded.","ALL","16 Weeks","28 Weeks",{"count":79,"type":20},150,"Pulmonary atresia (PA)\u002Fcritical stenosis (CS) with intact ventricular septum (PA\u002FCS-IVS) is a rare congenital heart disease (CHD), that presents heterogeneously. Prognosis is conditioned by the possibility of achieving a primary repair with biventricular circulation (BV) or a one-and-a-half ventricle solution vs. a palliative approach bound to a univentricular (UV) circulation in which both survival and quality of life are significantly impaired. Predicting UV circulation prenatally is still a challenge.\n\nThe aim of this study is: 1\u002F to evaluate the natural history of the disease and develop a prognostic model for the prediction of transplantation-free survival with a biventricular or a one-and-a-half repair at 2 years postnatal age 2\u002F To develop a model to predict the risk of right ventricle dependent coronary circulation 3\u002F To evaluate prenatal and postnatal outcomes in non-intervened fetuses with a confirmed postnatal diagnosis of PA-CS\u002FIVS including Intrauterine death, neonatal\u002FInfant death, number of required postnatal procedures, need for oxygen support, need for cardiac transplantation",[82,25,39],"Pulmonary Atresia With Intact Ventricular Septum",[84,85,86],"Prognosis","Prenatal diagnosis","Ultrasound","2025-09-08",{"date":89,"type":59},"2025-09-15",{"date":91,"type":59},"2024-02-01",{"date":93,"type":20},"2029-12-31",{"name":95,"class":66},"Hospital Universitario 12 de Octubre",{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":75,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":108,"studyType":21,"phases":4,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":119,"locationsCount":121},"100468929","effect-of-fetal-aortic-valvuloplasty-on-outcomes-100468929","NCT05386173","Effect of Fetal Aortic Valvuloplasty on Outcomes","Effect of Fetal Aortic Valvuloplasty on Outcomes. A Prospective Observational Cohort Study With a Comparison Cohort","FASSprosp","Inclusion Criteria:\n\nA. All of the following echocardiographic criteria need to be satisfied between 23+0 and 31+6 weeks (z-scores according to Schneider et al):\n\n1. Aortic valve stenosis with antegrade flow through the valve\n2. Predominantly left-to-right shunt at the atrial level\n3. Predominantly retrograde flow in the aortic arch between the first two brachiocephalic vessels\n4. Qualitatively depressed left ventricular function\n5. Left ventricular end-diastolic diameter Z-score \\> ±0\n6. Left ventricular inlet length in diastole :\n\n   1. Gestational age ≤ 24+6: Z-score \\> ±0\n   2. Gestational age 25+0 to 27+6: Z-score \\> -0.75\n   3. Gestational age ≥ 28+0: Z-score \\> -1.50\n7. Mitral valve diameter in diastole Z-score \\> -2.0\n\nB. All of the following postnatal treatment options need to be available: 1. Surgical or catheter based aortic valvotomy 2. Ross-Konno surgery 3. Norwood or hybrid stage-one surgery\n\nExclusion Criteria:\n\n1. Any associated cardiac defect except persistent left superior vena cava and coarctation of the aorta\n2. Any significant (i.e. that might influence outcome) extracardiac anomaly and\u002For known chromosomal aberration. Also, if such a condition is present at inclusion but diagnosed only after birth the case will be retrospectively excluded.","23 Weeks","31 Weeks",{"count":107,"type":20},200,"3 Years","In one of the most severe congenital heart defects, hypoplastic left heart syndrome (HLHS), the left ventricle is underdeveloped and the prognosis is worse than in most other heart defects. The underdevelopment can occur gradually during fetal growth caused by a narrowing of the aortic valve. At some international centers, such fetuses are treated with a balloon dilation of the narrowed valve, but there is no scientifically sound evidence that this treatment is effective.\n\nThe aim of this study is: 1\u002F to evaluate whether balloon dilation during the fetal period of a narrowed aortic valve can reduce the risk of the left ventricle becoming underdeveloped and the baby being born with a so-called univentricular heart (HLHS); 2\u002F to investigate whether such treatment improves the prognosis for this group of children with a very complex and severe heart defect and 3\u002F to also describe side effects and risks in fetuses and mothers of the fetal procedure.",[25,111,39,112],"Aortic Valve Stenosis","Hypoplastic Left Heart Syndrome","2025-03-18",{"date":115,"type":59},"2025-03-21",{"date":117,"type":59},"2021-01-01",{"date":93,"type":20},{"name":120,"class":66},"Queen Silvia Children's Hospital, Gothenburg, Sweden",13]