[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pulmonary-regurgitation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pulmonary-regurgitation":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,70,95],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100406265","berlin-registry-of-right-heart-interventions-100406265",false,"NCT04570163","Berlin Registry of Right Heart Interventions","Inclusion Criteria:\n\n* Patients with planned or recent valve interventions of the right heart (tricuspid regurgitation\u002F stenosis, pulmonary regurgitation\u002F stenosis)\n* \\>18 years\n* Written, documented consent\n\nExclusion Criteria:\n\n* Patients in care or unable to consent\n* Patients who are unable to comply with follow-up examinations\n* Patients who are detained in an institution","ALL","18 Years","120 Years",{"count":19,"type":20},200,"ESTIMATED","24 Months","OBSERVATIONAL","The present study evaluates patients after interventional therapy of valvular diseases of the right heart. Follow-up examinations include medical history taking, laboratory measurements and an echo. The aim is to assess the different interventional therapies and their impact on patient's outcome.",[25,26],"Tricuspid Regurgitation","Pulmonary Regurgitation","RECRUITING","2026-03-18",{"date":30,"type":31},"2026-03-19","ACTUAL",{"date":33,"type":31},"2020-06-16",{"date":35,"type":20},"2035-12-31",{"name":37,"class":38},"Charite University, Berlin, Germany","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":59,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":39},"100567453","phase-4-sodium-glucose-cotransporter-2-inhibitors-for-repaired-tetralogy-of-fallot-patients-for-enhancement-of-cardio-pulmonary-status-trial-100567453","NCT06668389","Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial","Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial (STEPS Trial)","STEPS","Inclusion Criteria:\n\n* rTOF\n* Aged 18 years or above\n* Voluntarily agrees to participate in the clinical trial and provide written informed consent\n\nExclusion Criteria:\n\n* Heart failure with reduced ejection fraction (HFrEF) with LVEF \\\u003C 40%\n* Planned cardiac and\u002For non-cardiac surgery in 3 months\n* Chronic kidney disease stages 4 to 5\n* Unable to perform cardiopulmonary test\n* Recent use of SGLT2 inhibitors within 6 months\n* Known hypersensitivity to SGLT2 inhibitors\n* History of diabetic ketoacidosis\n* Recent symptomatic hypoglycaemia within 6 months\n* Insulin dependent diabetes mellitus\n* History of perineum infection\n* Recent urinary tract infection within 6 months\n* Recent genital infection within 6 months\n* Other known contraindication to SGLT2 inhibitor\n* Pregnancy or breast feeding",{"count":49,"type":20},106,"INTERVENTIONAL",[52],"PHASE4","Repaired Tetralogy of Fallot (rTOF) is the leading cause of congenital cyanotic heart disease worldwide, involving up to 7-10% of congenital heart disease. With advances in open-heart surgical repair techniques and medical therapies, there is a significant increase in patients with rTOF surviving till late adulthood. One sequalae that nearly all rTOF patients develop during their lifetime is significant pulmonary regurgitation. Pulmonary regurgitation causes progressive right ventricular dilatation and systolic dysfunction, which in turn impairs cardio-pulmonary function and overall survival.\n\nThere is currently no pharmacological therapy proven to improve cardio-pulmonary function in rTOF patients. In a double-blind, placebo controlled, randomized controlled trial involving 33 rTOF patients, the use of beta-adrenergic receptor blocker Bisoprolol failed to improve maximal oxygen uptake (VO2 max) in the treatment group. Furthermore, there was no significant change in dimension of right ventricle on cardiac imaging, or heart failure biomarkers including brain natriuretic peptide (BNP) and atrial natriuretic peptide (ANP). In the APPROPRIATE trial involving 64 patients, angiotensin-converting-enzyme inhibitor (ACEI) Ramipril similarly failed to improve VO2 max despite an improved right ventricular long-axis shortening. In REDEFINE trial, 95 rTOF patients were randomized in to receive angiotensin receptor blocker (ARB) Losartan and control. At the end of study, there was no significant difference between the two groups in VO2 max, right ventricular ejection fraction, and other key outcomes.\n\nSodium-glucose cotransporter 2 (SGLT2) inhibitor is a promising therapy for rTOF patients. Clinical trials consistently demonstrated that SGLT2 inhibitors reduce heart failure hospitalization and mortality among patients with heart failure with or without diabetes mellitus. There have been growing body of evidence that demonstrate that SGLT2 inhibitors improve right ventricular function. In a preclinical study of rat with pulmonary hypertension induced right ventricular failure, empagliflozin was found to reduce pulmonary pressure, alleviate right ventricular hypertrophy and reduce myocardial fibrosis. In a pilot study involving 10 patients with adult congenital heart disease and systemic right ventricular failure, SGLT2 inhibitors improved cardio-pulmonary function as reflected by 6-minute walk test performance and New York Heart Association functional status. Most recently, investigators from DAPA-SERVE randomized controlled trial reported that among 92 patients with systemic right ventricular failure, those randomized to receive SGLT2 inhibitors had superior systemic right ventricular function with larger fractional area change (FAC) and more negative free-wall global longitudinal strain. Nevertheless, as these trials involve patients with right ventricular connections to the systemic circulation rather than pulmonary circulation in rTOF, it is uncertain whether the trial results can be extrapolated to the rTOF population. The critical knowledge gap our proposed randomized controlled trial seeks to address is whether SGLT2 inhibitors improve cardio-pulmonary function in rTOF patients.",[55,56,26,57,58],"Congenital Heart Disease","Repaired Tetralogy of Fallot (rTOF)","Sodium-glucose Cotransporter 2 (SGLT2) Inhibitor","Dapagliflozin (Forxiga)",[55,56,26,60,58],"Sodium-glucose cotransporter 2 (SGLT2) inhibitor","2025-05-19",{"date":63,"type":31},"2025-05-20",{"date":65,"type":31},"2025-05-12",{"date":67,"type":20},"2026-12-31",{"name":69,"class":38},"The University of Hong Kong",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":15,"minAge":78,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":50,"phases":81,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":39},"100516901","venusp-valve-pivotal-study-proteus-study-100516901","NCT06010563","VenusP-Valve Pivotal Study (PROTEUS STUDY)","Evaluation of the Performance of the VenusP-ValveTM System in Patients with Native RVOT Dysfunction","PROTEUS","Inclusion Criteria:\n\n1. Weight ≥25kg (55 lbs.)\n2. Age ≥ 12 years olds\n3. Patients have a dysfunctional native RVOT with severe pulmonary regurgitation (i.e., severe pulmonary regurgitation as determined by echocardiography or pulmonary regurgitant fraction ≥30% as determined by cardiac magnetic resonance imaging) and without significant pulmonary stenosis (significant pulmonary stenosis is defined as gradient more than 25mmHg) and are clinically indicated for intervention:\n\n1\\) For symptomatic patients, fitting the following criteria:\n\n* Severe pulmonary regurgitation measured by echocardiogram or pulmonary regurgitant fraction ≥30% measured by CMR 2) For asymptomatic patients, including any 2 of the following criteria:\n* Mild or moderate RV or LV systolic dysfunction.\n* Severe RV dilation (RVEDVI ≥145 mL\u002Fm2 or RVESVI ≥ 75 mL\u002Fm2or RVEDV \\>2 × LVEDV).\n* Progressive reduction in objective exercise tolerance. 4. Patient is willing to consent to participate in the study and will commit to completion of all follow-up requirements.\n\nExclusion Criteria:\n\n1. Clinical or biological signs of infection including active endocarditis.\n2. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.\n3. Leukopenia, anemia, thrombocytopenia, or any known blood clotting disorder, deemed clinically significant after consultation with Haemato-oncology specialists.\n4. Inappropriate anatomy for femoral or right internal jugular vein (RIJ) introduction and delivery of the VenusP-ValveTM System.\n5. RVOT anatomy or morphology that is unfavorable for device anchoring.\n6. Anatomy unable to accommodate VenusP-Valve delivery system.\n7. Angiographic evidence of coronary artery compression that would result from transcatheter pulmonary valve replacement (TPVR).\n8. Emergency interventional\u002Fsurgical procedures within 30 days prior to the index procedure.\n9. Planned significant and relevant concomitant procedure at time of VenusP-Valve implant.\n10. Any planned interventional\u002Fsurgical procedures to be performed within the 30 days follow-up from VenusP-Valve implant.\n11. Known history of intravenous drug abuse in the past 5 years, without certificate of completion of rehabilitation from a specialist.\n12. Major or progressive non-cardiac disease resulting in a life expectancy of less than one year.\n13. Known hypersensitivity or contraindication to antiplatelet, antithrombotic medications, or nitinol (titanium or nickel) leading to be unable to undergo index procedure per physicians' judgement\n14. Positive pregnancy test at baseline (prior to CT angiography and again prior to implant procedure) in female patients of child-bearing potential.\n15. Currently participating in an investigational drug or another device study.\n16. Patient or guardian unwilling or unable to provide written informed consent or comply with follow-up requirements.\n17. The investigators consider that the patients are not suitable to participate in this research.","12 Years",{"count":80,"type":20},60,[82],"NA","A prospective, multi-center, non-randomized interventional study to evaluate the safety and effectiveness of the VenusP-ValveTM System in patients with native right ventricular outflow tract (RVOT) dysfunction.\n\nPost procedure, a clinical visit will be scheduled at pre-discharge, 30 days, 6 months, 12 months, and annually thereafter to 10 years.\n\nAbout 60 subjects will be enrolled in this study. Data analysis will be performed after all enrolled subjects complete 6-month follow-up and the primary endpoint analysis report will be submitted to FDA for PMA approval.",[26],"2025-02-25",{"date":87,"type":31},"2025-02-28",{"date":89,"type":31},"2024-06-11",{"date":91,"type":20},"2034-08-30",{"name":93,"class":94},"Venus MedTech (HangZhou) Inc.","INDUSTRY",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":15,"minAge":78,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":50,"phases":104,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":117},"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":103,"type":20},120,[82],"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.",[107,26],"Tetralogy of Fallot","2019-09-06",{"date":110,"type":31},"2019-09-10",{"date":112,"type":31},"2019-04-01",{"date":114,"type":20},"2031-12-31",{"name":116,"class":38},"Rigshospitalet, Denmark",3]