[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tetralogy-of-fallot\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tetralogy-of-fallot":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,38,59,93,120,151,179,206,228,255,277],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":16,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":37},"100075986","molecular-and-cellular-characterization-of-cardiac-tissue-in-postnatal-development-100075986",false,"NCT00243776","Molecular and Cellular Characterization of Cardiac Tissue in Postnatal Development","Inclusion Criteria:\n\n* Patients undergoing cardiopulmonary bypass surgery\n* Patients undergoing surgery for repair of congenital heart disease such as ventricular septal defect or defective mitral or aortic valves.\n\nExclusion Criteria:\n\n* Prior cardiac surgery\n* History of atrial fibrillation or other atrial arrhythmias prior to operation\n* History of heart failure","ALL","20 Years",{"count":18,"type":19},600,"ESTIMATED","OBSERVATIONAL","The study team will use small pieces of human hearts which are removed as part of a required surgical procedure to study different objectives. One of the objective is how calcium ions pass through the membrane of heart cells in order to tell the heart cell how much force to contract with when the heart beats. Investigators will also study the proteins and RNA of these pieces to determine how the newborn heart cells control their force of contraction differently from adult heart cells. Investigators hypothesize that infant hearts have different regulation of calcium entry than adult hearts. The study team also wants to study combinations of 3D cardiac spheres with multiple environmental cues that can improve functional and metabolic maturation of Human pluripotent stem cell-derived cardiomyocytes (hPSC-CMs) and generate a more clinically relevant cell model.",[23,24],"Congenital Heart Disease","Tetralogy of Fallot","RECRUITING","2026-05-04",{"date":28,"type":29},"2026-05-06","ACTUAL",{"date":31,"type":4},"2005-04",{"date":33,"type":19},"2027-12",{"name":35,"class":36},"Emory University","OTHER",1,{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":15,"minAge":45,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":48,"conditions":49,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":37},"100448707","pathophysiologic-mechanism-for-arrhythmias-and-impaired-aerobic-capacity-in-tetralogy-of-fallot-and-other-congenital-heart-diseases-100448707","NCT05122962","Pathophysiologic Mechanism for Arrhythmias and Impaired Aerobic Capacity in Tetralogy of Fallot and Other Congenital Heart Diseases","PACT","Inclusion Criteria:\n\n* Moderate (or greater) PR based on quantitative Doppler echocardiography.\n* Repaired TOF\n* Congenital Heart Disease diagnosis including but not limited to Ebstein's anomaly, coarctation of the aorta (COA), Fontan palliation, transposition of the great arteries, congenitally corrected transposition of the great arteries.\n\nExclusion Criteria:\n\n* Pregnant Women\n* Unable to undergo CMRI","18 Years",{"count":47,"type":19},300,"This study is being done to determine the mechanism(s) contributing to the onset of symptoms (i.e. shortness of breath and\u002For palpitations) as well as changes in heart structure in patients with congenital heart disease (CHD)",[24,23],"2026-02-03",{"date":52,"type":29},"2026-02-05",{"date":54,"type":29},"2021-11-01",{"date":56,"type":19},"2026-10",{"name":58,"class":36},"Mayo Clinic",{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":15,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":92},"100575392","high-intensity-interval-training-in-patients-with-a-right-ventricle-to-pulmonary-artery-conduit-100575392","NCT06771687","High Intensity Interval Training in Patients With a Right Ventricle to Pulmonary Artery Conduit","Right HIIT","Inclusion Criteria:\n\n1. Congenital absence of an unobstructed connection between the right ventricle and pulmonary artery, requiring surgical implantation of a right ventricle to pulmonary artery conduit, including patients with:\n\n   1. Truncus arteriosus\n   2. Pulmonary atresia with ventricular septum defect\n   3. Severe tetralogy of Fallot\n   4. Other forms of pulmonary atresia with biventricular correction\n2. Age 12 to 45 years.\n3. Current follow-up in Academic Center for Congenital Heart Disease (ACAHA; Erasmus MC Rotterdam and Radboudumc Nijmegen).\n4. Signed informed consent.\n\nExclusion Criteria:\n\n1. Ventricular arrhythmias and\u002For channelopathy.\n2. Implantable cardioverter defibrillator implantation due to inherited arrhythmia syndromes.\n3. Left ventricular ejection fraction and\u002For right ventricular ejection fraction less than 30 percent.\n4. Elite athletes (i.e. national team, Olympians, professional athletes, exercising equal to or more than 10 h\u002Fweek, according to definition in 2020 European Society of Cardiology Guidelines for Sports Cardiology and Exercise in Patients with Cardiovascular Disease).\n5. Cardiovascular lesions requiring intervention (according to international guidelines).\n6. Cardiovascular intervention (surgery or catheterization) less than 6 months ago.\n7. Cardiovascular medication changes less than 3 months ago.\n8. Hospitalization for treatment of cardiovascular events less than 6 months ago.\n9. Comorbidities or developmental delay impeding exercise training (e.g. neuromuscular disease, symptomatic myocardial ischemia, syndromic diagnoses such as trisomy 21).\n10. Inability to provide informed consent.","12 Years","45 Years",{"count":69,"type":19},38,"INTERVENTIONAL",[72],"NA","The goal of this clinical trial is to learn if a specific type of exercise training (high intensity interval training) can improve exercise capacity in people with a congenital heart defect that required the creation of a new connection between the right ventricle and pulmonary artery. This includes people with a truncus arteriosus, pulmonary atresia with a ventricular septal defect or severe tetralogy of Fallot. This study focuses on people aged 12 to 45 years. The main questions it aims to answer are:\n\n* Can a 12-week home-based high intensity interval exercise training program increase the exercise capacity?\n* Can factors that predict whether or not the exercise training program can increase the exercise capacity in specific people be identified?\n\nResearchers will compare the results from the intervention group to the control group. Participants will be assigned to one of these two groups at inclusion. The control group will also receive the intervention, after the control period.\n\nParticipants will:\n\n* Participate in a 12-week home-based exercise training program (3x30 minutes a week, digitally supervised);\n* Attend 2 or 3 study visits (which partially is standard care) (2 visits for the intervention group, 3 visits for the control group);\n* Each study visit includes: echocardiography, magnetic resonance imaging (MRI) of the heart, cardiopulmonary exercise testing (CPET), blood and feces sampling, and questionnaires on quality of life and physical activity.",[23,75,76,24],"Truncus Arteriosus","Pulmonary Atresia",[78,79,76,24,80,81,82],"Heart Defects, Congenital","Truncus Arteriosus, Persistent","Physical Conditioning, Human","High-Intensity Interval Training","Exercise Test","2026-01-19",{"date":85,"type":29},"2026-01-21",{"date":87,"type":29},"2025-01-16",{"date":89,"type":19},"2028-10",{"name":91,"class":36},"Erasmus Medical Center",2,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":15,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":70,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":119},"100417282","phase-1-beta-blocker-administration-for-cardiomyocyte-division-100417282","NCT04713657","Beta-blocker Administration for Cardiomyocyte Division","Mechanistic Clinical Trial of Beta-Blocker Administration For Reactivating Cardiomyocyte Division In Tetralogy of Fallot","Inclusion Criteria:\n\n* Male and female infants \\\u003C 60 days of age with a diagnosis of tetralogy of Fallot (ToF) with pulmonary stenosis (PS) or double outlet right ventricle (DORV), tetralogy type by echocardiogram, who weigh greater than 2 kg at the time of consent and are tolerating enteral feeds.\n* DORV variant\n\nExclusion Criteria:\n\n* congenital atrio-ventricular block on EKG (PR interval \\> 120 ms),\n* concomitant medication administration that interacts with propranolol,\n* patient family is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason,\n* gestation age \\\u003C 35 weeks,\n* infants of diabetic mothers, asthma or underlying respiratory disease,\n* presence of metal implants in infants.","30 Days","60 Days",{"count":103,"type":19},40,[105],"PHASE1","Heart failure is a common long-term complication in patients with congenital heart disease (CHD). Medical treatments to promote regeneration of new healthy heart muscle cells have the potential to provide new heart failure treatments for these patients. The development of such therapies is limited by the poor understanding of the ways in which heart muscles grow after birth. Investigators have learned that humans without heart disease generate new heart muscles cells up to the age of 20 years old and that this is decreased in patients with congenital heart disease like Tetralogy of Fallot. Investigators are trying to determine if treatment with a medicine called Propranolol can increase heart muscle cell proliferation and, with that, normalize heart growth. Investigators will examine discarded heart muscle tissue that is obtained during surgery for the presence of new heart muscle cells. Propranolol is approved by the Food and Drug Administration (FDA) to treat a certain kind of benign tumor in infants (hemangioma), but it is not currently approved by the FDA to increase heart muscle growth.",[24,108],"Double Outlet Right Ventricle",[24,108],"2025-11-14",{"date":112,"type":29},"2025-11-18",{"date":114,"type":29},"2022-12-16",{"date":116,"type":19},"2030-12-31",{"name":118,"class":36},"Weill Medical College of Cornell University",3,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":15,"minAge":127,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":37},"100370678","nirs-in-congenital-heart-defects---correlation-with-echocardiography-100370678","NCT04106479","NIRS in Congenital Heart Defects - Correlation With Echocardiography","Do Cerebral and Renal Saturations Measured With Near-infrared Spectroscopy Correlate With Echocardiographic Markers of Perfusion and Cardiac Performance in Congenital Heart Disease?","Inclusion Criteria:\n\nA prospective study will be conducted of all newborns with tetralogy of fallot, trucus arteriosus, D-transposition of great arteries, PS, AS, coarctation of the aorta, DILV, AVC, DORV, HLHS, TA and PAIVS consecutively admitted at our institution (Montreal Children's Hospital) neonatal intensive care unit (NICU) from January 2018 to January 2020. Patients with CHD will be compared to a control population of term infants admitted and monitored in the NICU with antenatal suspicion of coarctation, ruled-out postnatally.\n\nExclusion Criteria:\n\nPatients will be excluded if premature less than 34 weeks of estimated gestational age (GA) at birth or if parents do not consent. Parental consent can be withdrawn at any time during the study.","0 Days","7 Days",{"count":130,"type":19},100,"Neonatal patients with congenital heart defects (CHD) have changing physiology in the context of transitional period. Patients with CHD are at risk of low perfusion status or abnormal pulmonary blood flow. Near infrared spectroscopy has been used in neonatal intensive care units (NICU) to measure end-organ perfusion. The investigator plan on monitoring newborns with CHD admitted to the NICU with NIRS and echocardiography during the first week of life and correlate measures of perfusion from Dopplers to cerebral and renal NIRS.",[133,134,135,136,137,138,139,140,76,141,24],"Congenital Heart Defect","Single-ventricle","Coarctation of Aorta","Atrioventricular Canal","Hypoplastic Left Heart","Transposition of Great Vessels","Interrupted Aortic Arch","Tricuspid Atresia","Aortic Atresia","2025-06-12",{"date":144,"type":29},"2025-06-17",{"date":146,"type":29},"2019-10-11",{"date":148,"type":19},"2025-12-01",{"name":150,"class":36},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":15,"minAge":158,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":70,"phases":161,"briefSummary":162,"conditions":163,"keywords":167,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":178},"100501442","effects-branch-pa-stenting-d-tga-tof-and-ta-100501442","NCT05809310","Effects Branch PA Stenting d-TGA, ToF and TA","The Effects of Branch Pulmonary Artery Stenting in d-TGA, ToF and TA: a Randomized Control Trial","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n* Patients with d-TGA post ASO, ToF or TA\n* ≥8 years\n\nExclusion Criteria:\n\nOne or more of the following inclusion criteria:\n\n* All class IIa indications for a branch PA intervention:\n* Persistent decreased RV function (based on gold standard CMR)\n\n  * \\\u003C18 years RVEF ≤55% (28)\n  * ≥18 years RVEF\\\u003C50% (29)\n* Progressive tricuspid regurgitation (TR) (≥moderate)\n* Isolated bifurcation stenosis:\n\n  * Significant unilateral stenosis (≥50%)\n  * Borderline bilateral PA stenosis (40-70%)\n* Unbalanced perfusion (≤35\u002F65%)\n* RV\u002FLV pressure ratio \\> 2\u002F3 based on echocardiography\n* Reduced lung perfusion or decreased objective exercise capacity (based of gold standard VO2 max during CPET)\n\n  * \\\u003C18 years VO2 peak \\\u003C35 mL∙kg-1∙min-1 (boys) VO2 peak \\\u003C30 mL∙kg-1∙min-1 (girls) (30)\n  * ≥18 years VO2 peak \\\u003C27 mL∙kg-1∙min-1 (men) VO2 peak \\\u003C19 mL∙kg-1∙min-1 (women) (31)","8 Years",{"count":160,"type":19},56,[72],"The goal of this randomized controlled trial is to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with d-TGA, ToF and TA.\n\nThe main question\\[s\\] it aims to answer are:\n\nThe primary study objective is to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with d-TGA, ToF and TA. The secondary objectives are 1) to assess the effects of percutaneous interventions for branch PA stenosis on RV function and 2) to define early markers for RV function and adaptation to improve timing of these interventions.\n\nParticipants will undergo the same series of examinations at baseline and approximately 6 months follow-up (within 6 week time-range) as part of standard care: conventional transthoracic echocardiogram (TTE), cardiopulmonary exercise testing (CPET) and conventional Cardiac Magnetic Resonance (CMR) including a low dose dobutamine stress MRI to assess RV functional reserve. The low dose dobutamine stress MRI will be performed in the interventional group from the UMC Utrecht\u002FWKZ and Erasmus MC because the LUMC and AUMC do not have a suitable infrastructure for the low dose dobutamine stress MRI and this cannot be achieved throughout the duration of this study. The baseline CMR in the interventional group will be performed as close as possible prior to the intervention but maximal 4 weeks prior to the intervention. In addition, the intervention group will undergo standard RV pressure measurements during the intervention. Quality of life (QoL) questionnaires will be obtained at baseline and 2 weeks post intervention (intervention group) or a similar time range in the control group, which is based on experts opinion. TTE, CPET and conventional CMR will be performed within 2-4 years follow-up to assess the long-term effects of percutaneous PA interventions.\n\nResearchers will compare the difference in VO2 max (% predicted) between the interventional group (TGA, ToF or TA patients with a class II indication for a PA intervention who will undergo a percutaneous intervention for a PA stenosis) and the control group (TGA, ToF or TA patients with a class II indication for a PA intervention who will undergo conservative management)",[138,24,75,164,165,166,23],"Pulmonary Artery Stenosis Supravalvular Congenital","Stent Stenosis","Right Ventricular Dysfunction",[168],"Exercise capacity","2025-03-25",{"date":171,"type":29},"2025-03-30",{"date":173,"type":29},"2023-04-18",{"date":175,"type":19},"2027-12-31",{"name":177,"class":36},"UMC Utrecht",4,{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":187,"sex":15,"minAge":188,"maxAge":4,"enrollmentInfo":189,"targetDuration":191,"studyType":20,"phases":4,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":37},"100461457","repaired-tetralogy-of-fallot-italian-registry-100461457","NCT05288894","Repaired Tetralogy of Fallot Italian Registry","Multicenter Italian Registry From the Italian Pediatric Cardiology Society (SICP) Working Group (WG) on CMR\u002FCT for the Repaired Tetralogy of Fallot","RETE-Fallot","Inclusion Criteria:\n\n* Patients with Repaired - TOF\n\nExclusion Criteria:\n\n* Age \\\u003C 10 years\n* Other associated complex pathology such as MAPCAs, Atrioventricular canal, Ebstein\n* Incomplete CMR exam",true,"10 Years",{"count":190,"type":19},150,"6 Years","The CMR\u002FCT WG of the Italian pediatric cardiology society set up a multi-center observational clinical database of repaired-TOF evaluated. This registry will enroll prospectively patients evaluated by CMR for clinical indication in most of the CHD Italian centers. Data collection will include surgical history, clinical data, imaging data, and also adverse cardiac events for a period of 6 years.",[24,194,195,196],"Cardiac Death, Sudden","Cardiac Arrhythmia","Cardiac Event","2024-04-15",{"date":199,"type":29},"2024-04-16",{"date":201,"type":29},"2021-03-01",{"date":203,"type":19},"2027-03",{"name":205,"class":36},"Azienda Ospedaliero, Universitaria Ospedali Riuniti",{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":70,"phases":214,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":37},"100457404","electroanatomic-interactions-between-transcatheter-pulmonary-valve-prostheses-and-anatomic-isthmuses-in-repaired-tetralogy-of-fallot-100457404","NCT05236153","Electroanatomic Interactions Between Transcatheter Pulmonary Valve Prostheses and Anatomic Isthmuses in Repaired Tetralogy of Fallot","Inclusion Criteria:\n\n* Diagnosis of tetralogy of Fallot (TOF) or double outlet right ventricle (DORV)\n* Referred for transcatheter pulmonary valve replacement (TPVR) per routine clinical indications\n* Weight \\>=25 kg",{"count":213,"type":19},60,[72],"Individuals with repaired Tetralogy of Fallot (rTOF) remain at risk for sudden cardiac death from ventricular tachycardia (VT). Transcatheter pulmonary valve replacement (TPVR) indications continue to broaden, yet its capability to reduce the risk of VT and sudden cardiac death remains unknown. Thus, in a cohort of participants with rTOF who are presenting for TPVR the investigators intend to: (1) quantify and localize right ventricular (RV) isthmuses with abnormal voltage and\u002For conduction velocity; (2) identify which RV isthmuses are at risk of being \"jailed\" by TPV prostheses; and (3) explore the feasibility of omnipolar technology to characterize wavefront directionality and differentiate slow conduction from conduction block.",[24,217,218],"Ventricular Tachycardia","Sudden Cardiac Death","2023-02-06",{"date":221,"type":29},"2023-02-08",{"date":223,"type":29},"2022-11-04",{"date":225,"type":19},"2024-01-01",{"name":227,"class":36},"Boston Children's Hospital",{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":15,"minAge":45,"maxAge":236,"enrollmentInfo":237,"targetDuration":188,"studyType":20,"phases":4,"briefSummary":239,"conditions":240,"keywords":4,"overallStatus":245,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":37},"100384660","canadian-adult-congenital-heart-disease-intervention-registry-100384660","NCT04288596","Canadian Adult Congenital Heart Disease Intervention Registry","The Canadian Registry for Adults With Congenital Heart Disease Interventions","C-ACHDiR","Inclusion Criteria:\n\n* participants must be 18 years or older referred for intervention for one of five ACHD conditions including diagnostic catheterization for complex ACHD patients (Tetralogy of Fallot, Fontan, and transposition of the great vessels, single ventricle, truncus arteriosus); transcatheter closure of atrial septal defects; transcatheter closure of patent foramen ovale; coarctation of aorta stenting, and percutaneous pulmonary valve implantation.\n\nExclusion Criteria:\n\n* participants below the age of 18\n* participants residing outside of Canada","110 Years",{"count":238,"type":19},9000,"The ACHDi Registry study will create a foundational database for adult congenital heart disease interventions. This Pan-Canadian Registry will collect clinical and patient-reported information that will enable the evaluation of care processes and outcomes in five most common ACHDi interventions by enabling prospective and retrospective registry-based studies to answer important clinical practice and policy-relevant questions.",[241,242,24,243,135,138,244],"Atrial Septal Defect","Patent Foramen Ovale","Fontan","Percutaneous Pulmonary Valve Implantation","NOT_YET_RECRUITING","2020-02-27",{"date":248,"type":29},"2020-02-28",{"date":250,"type":19},"2020-04-01",{"date":252,"type":19},"2030-04-01",{"name":254,"class":36},"University Health Network, Toronto",{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":15,"minAge":66,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":70,"phases":264,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":119},"100368962","early-versus-later-re-valving-in-tetralogy-of-fallot-with-free-pulmonary-regurgitation-100368962","NCT04084132","Early Versus Later Re-valving in Tetralogy of Fallot With Free Pulmonary Regurgitation","Early Versus Later Re-valving in Tetralogy of Fallot With Free Pulmonary Regurgitation - Combined Cross-sectional and Prospective, Multi-centre, Randomized, Parallel-group Clinical Trial","Inclusion Criteria:\n\n1. ToF with pulmonary stenosis repaired with a TAP within the first two years of life.\n2. RVOT anatomy is suitable for implantation of an adult sized conduit ( 18 mm homograft or Contegra graft) as assessed by MRI.\n\nExclusion Criteria:\n\n1. ToF with pulmonary atresia, ToF with common atrioventricular canal, ToF with absent pulmonary valve syndrome, major aortopulmonary collateral arteries and other significant associated anomalies.\n2. Palliation with a shunt (Blalock-Taussig or central) at any time.\n3. The patient is symptomatic.\n4. Sustained supraventricular or ventricular arrhythmia.\n5. RVEDVi \\> 140 mL\u002Fm2 as assessed by MRI (appendix 1).\n6. RVESVi \\> 60 mL\u002Fm2 as assessed by MRI.\n7. RVEF \\\u003C 50 % as assessed by MRI.\n8. Moderate or severe tricuspid regurgitation as assessed by echocardiography or MRI.\n9. Significant residual lesions requiring intervention (e.g. ventricular septal defect, aortic regurgitation, branch pulmonary artery stenosis).\n10. Co-morbidity preventing exercise testing (e.g. genetics, neuro-cognitive dysfunction, physical disability).\n11. Contraindication for MRI (e.g. permanent pacemaker, intra-cardiac defibrillator, intracranial ferro-magnetic device).\n12. Pregnancy at time of inclusion.\n13. Age \\\u003C 12 or unable to comply with instructions given during MRI or exercise testing.",{"count":263,"type":19},120,[72],"Tetralogy of Fallot (ToF) is a congenital heart defect with four major features including right ventricular outflow tract obstruction. About 25 children are born with this condition in Denmark every year. Corrective surgery is usually performed within the first year. In 50 % of patients, enlargement with a patch is necessary to achieve relief of the outflow tract obstruction. This however results in severe pulmonary regurgitation, which eventually leads to volume overload, right ventricular dysfunction and arrhythmia. To avoid these late complications, pulmonary valve replacement with a prosthesis if performed when patients meet the current guideline criteria. Most patients meet the guideline criteria for revalving when they are between 20 and 30 years of age. The current guidelines however, are based solely on retrospective studies and novel research reveals that in more than 50 % of patients who are treated according to current practice, right ventricular volumes and function as well as exercise capacity and burden of arrhythmia do not normalize or improve. 500 patients with ToF will be enrolled in a multicentre, cross-sectional study, which will yield information about the long-term outcomes after initial repair of ToF, as well as suggestions about the optimal timing for re-valving. Among patients included in the cross-sectional study, 120 patients with free pulmonary regurgitation, will be randomized evenly for early or later re-valving with at least 10-years of follow-up, for evaluation of long-term efficacy and safety of early re-valving.",[24,267],"Pulmonary Regurgitation","2019-09-06",{"date":270,"type":29},"2019-09-10",{"date":272,"type":29},"2019-04-01",{"date":274,"type":19},"2031-12-31",{"name":276,"class":36},"Rigshospitalet, Denmark",{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":11,"sex":15,"minAge":45,"maxAge":4,"enrollmentInfo":284,"targetDuration":16,"studyType":20,"phases":4,"briefSummary":285,"conditions":286,"keywords":289,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":301,"locationsCount":37},"100350035","french-national-registry-of-patients-with-tetralogy-of-fallot-and-implantable-cardioverter-defibrillator-100350035","NCT03837574","French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator","DAI-T4F","Inclusion Criteria:\n\n* tetralogy of Fallot\n* implantable cardioverter defibrillator\n\nExclusion Criteria:\n\n* age \\\u003C 18 years",{"count":190,"type":19},"National french registry of patients with tetralogy of Fallot and implantable cardioverter defibrillator.",[24,287,23,218,288],"Implantable Defibrillator User","Ventricular Arrythmia",[290,291,292,293,294],"tretalogy of fallot","implantable cardioverter defibrillator","congenital heart disease","sudden cardiac death","ventricular arrhythmia","2019-02-09",{"date":297,"type":29},"2019-02-12",{"date":299,"type":29},"2010-12-01",{"date":116,"type":19},{"name":302,"class":36},"Paris Sudden Death Expertise Center"]