[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rheumatic-heart-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rheumatic-heart-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,44,72,96,109,129,151,186,212,239,262,287,309],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100053888","testing-a-registry-based-strategy-act-to-reduce-loss-to-follow-up-in-rheumatic-heart-disease-screening-in-uganda-100053888",false,"NCT07606131","Testing a Registry-Based Strategy (ACT+) to Reduce Loss to Follow-Up in Rheumatic Heart Disease Screening in Uganda","Developing and Testing a Registry-Enabled Strategy (ACT+) to Reduce Loss to Follow-Up Between Screening and Confirmation of Rheumatic Heart Disease in Uganda","SHIELD 2","Inclusion Criteria: Community Members\n\n* 18 years of age or older\n* Received a positive ADUNU echocardiographic screening result within the past 24 months OR parent\u002Flegal guardian of a minor who received a positive ADUNU echocardiographic screening result within the past 24 months\n\nInclusion Criteria: Providers\n\n* Employed at an ADUNU-participating facility or confirmatory echo facilities at the time of study\n* Holds a designated ADUNU role (nurse screener, confirmatory provider, or referral support staff) or is involved in RHD screening, diagnosis or care\n* Ability to provide informed consent in Acholi, Luo, or English\n\nInclusion Criteria: Regional RHT ACT Nurse Coordinator\n\n* Employed as a Regional ACT Nurse at the time of study\n* Has familiarity with ADUNU program\n* Ability to provide informed consent in Acholi, Luo, or English\n\nInclusion Criteria: District Health Office Team Members and District RHD Focal Persons\n\n* Employed at District Health Office within an ADUNU-participating district\n* Has familiarity with ADUNU program\n* Ability to provide informed consent in Acholi, Luo, or English\n\nExclusion Criteria:\n\n* No formal exclusion criteria beyond inability to provide informed consent. Individuals with significant cognitive or communication impairment precluding interview participation will not be enrolled.",true,"ALL",{"count":20,"type":21},16,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study aims to improve follow-up care after positive rheumatic heart disease (RHD) screening in Northern Uganda. It will identify barriers and co-develop an enhanced ACT+ strategy, then evaluate its effectiveness in increasing linkage to confirmatory echocardiography, along with its adoption, acceptability, and feasibility. Secondary outcomes include time to diagnosis, initiation of treatment, and factors influencing implementation.",[27],"Rheumatic Heart Disease",[29,30],"Rheumatic heart disease","SHIELD","NOT_YET_RECRUITING","2026-07-10",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":21},"2026-08-01",{"date":39,"type":21},"2028-06-01",{"name":41,"class":42},"Children's Hospital Medical Center, Cincinnati","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":18,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":43},"100604171","phase-3-a-non-inferiority-trial-of-stopping-penicillin-in-early-rheumatic-heart-disease-goal-stop-100604171","NCT07146048","A Non-Inferiority Trial of Stopping Penicillin in Early Rheumatic Heart Disease: GOAL-Stop","GOAL-Stop","Inclusion Criteria:\n\n* Participated in GOALIE\n* Concluded GOALIE with either echocardiographic normalization or stable mild RHD\n* Between ages 5-20 years at time of enrollment\n\nExclusion Criteria:\n\n* RHD Stage C\u002FD at GOALIE end of study echocardiogram\n* Relocation to extremely distant residence or school\n* Clinically documented penicillin allergy","5 Years","20 Years",{"count":54,"type":21},922,[56],"PHASE3","GOAL-Stop is a randomized, controlled, non-inferiority trial designed to evaluate whether discontinuing secondary antibiotic prophylaxis (SAP) is non-inferior to continuing SAP in preventing progression of rheumatic heart disease (RHD) among children and adolescents. The trial will enroll participants aged 5-20 years with previously diagnosed mild RHD who have received at least 2 years of SAP and who demonstrate either echocardiographic normalization or stability (persistent mild RHD). Participants will be randomized to either continue SAP or discontinue SAP for 2 years. The primary outcome is echocardiographic progression of RHD at 2 years, assessed by blinded adjudicators using the 2023 World Heart Federation criteria. Subgroup analyses will evaluate outcomes in participants with echocardiographic normalization versus stable mild RHD, and an exploratory analysis will assess whether outcomes differ by prior prophylaxis route (oral vs. intramuscular).",[27],[29,60,61,62],"global health","secondary prophylaxis","children","RECRUITING","2026-06-18",{"date":66,"type":35},"2026-06-22",{"date":68,"type":35},"2026-03-23",{"date":70,"type":21},"2029-12-31",{"name":41,"class":42},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":43},"100640746","artificial-intelligence-to-scale-early-rheumatic-heart-disease-detection-100640746","NCT07599956","Artificial Intelligence to Scale Early Rheumatic Heart Disease Detection","SHIELD 1","Inclusion Criteria:\n\n* Employed at a participating ADUNU facility\n* Holds a designated role in the ADUNU program as a nurse screener\n\nExclusion Criteria:\n\n* None. The pragmatic trial design includes all eligible staff at participating facilities.",{"count":80,"type":21},62,[24],"The main goal of this project is to see if RADAR (Rapid AI-assisted Detection and Analysis of Rheumatic heart disease), which is a machine and deep-learning AI model, can help make rheumatic heart disease (RHD) screening easier to expand. Specifically, the project will test whether RADAR can screen as accurately-or more accurately-than current methods, and whether it can be used effectively in different low-resource settings. The aim is to show that RADAR could be adopted and used widely around the world.",[27],[29,85,86,87],"Artificial Intelligence","Deep Learning","Machine Learning","2026-05-22",{"date":90,"type":35},"2026-05-27",{"date":92,"type":21},"2026-06",{"date":94,"type":21},"2028-06",{"name":41,"class":42},{"id":97,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":25,"conditions":100,"keywords":101,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":108,"locationsCount":43},"100638280",{"count":20,"type":21},[24],[27],[29,30],"2026-05-19",{"date":104,"type":35},"2026-05-26",{"date":106,"type":21},"2026-06-01",{"date":39,"type":21},{"name":41,"class":42},{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":43},"100499447","accelerating-delivery-of-rheumatic-heart-disease-preventive-interventions-in-northern-uganda-100499447","NCT05783375","Accelerating Delivery of rheUmatic Heart Disease Preventive iNterventions in Northern Uganda","ADUNU","Inclusion Criteria:\n\n* residing in one of two involved districts in Uganda\n* providers at HCIIIs and HCIVs located in one of two involved Ugandan districts\n\nExclusion Criteria:\n\n* None",{"count":117,"type":21},221,[24],"The goal of this prospective study is to evaluate the feasibility, sustainability, and public health impact of a district-based program for secondary prevention of Rheumatic Heart Disease (RHD) in Uganda.",[27],"2026-05-13",{"date":123,"type":35},"2026-05-15",{"date":125,"type":35},"2024-05-01",{"date":127,"type":21},"2028-01-31",{"name":41,"class":42},{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":18,"minAge":136,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":139,"phases":4,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":4},"100604189","vitamin-k-antagonist-in-rheumatic-heart-disease-patients-with-mechanical-heart-valves-our-current-status-100604189","NCT07146282","Vitamin K Antagonist in Rheumatic Heart Disease Patients With Mechanical Heart Valves: Our Current Status","VKA and RHD","Inclusion Criteria:\n\n* Confirmed presence of a mechanical heart valve.\n* Aged ≥18 years\n\nExclusion Criteria:\n\n* Pregnancy.\n* Active bleeding disorders.\n* Severe liver\u002Fkidney disease (if affecting anticoagulation).","18 Years",{"count":138,"type":21},165,"OBSERVATIONAL","VKA in RHD patients with MHV: our current status",[27],"2025-08-21",{"date":144,"type":35},"2025-08-28",{"date":146,"type":21},"2025-09",{"date":148,"type":21},"2027-10",{"name":150,"class":42},"Ahmed Hassan Rostom Ibrahim",{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":17,"sex":18,"minAge":136,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":22,"phases":162,"briefSummary":165,"conditions":166,"keywords":172,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":43},"100598966","phase-1-clinical-trial-phase-iiia-to-evaluate-the-safety-and-immunogenicity-of-streptincor-100598966","NCT07078357","Clinical Trial Phase I\u002FIIa to Evaluate the Safety and Immunogenicity of StreptInCor","Phase I\u002FIIa Clinical Trial to Evaluate the Safety and Immunogenicity of StreptInCor, a Synthetic Vaccine Against Streptococcus Pyogenes, in Healthy Adult Volunteers.","StreptInCorVac","Inclusion Criteria:\n\n* • Healthy male or female volunteers, aged between 18 and 45 years;\n\n  * Availability to undergo all procedures throughout the study period;\n  * Provide free and informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Participation in clinical trials within the last year\n* Participation in cohort studies\n* Diagnosis of concomitant infections or diseases that may affect immunity, including active HIV infection, hepatitis B, hepatitis C, diabetes mellitus, neoplasms, and autoimmune diseases;\n* Current or previous diagnosis or family history of ARF, chorea, obsessive-compulsive disorder, or glomerulonephritis;\n* Current or previous diagnosis of heart diseases;\n* Severe asthma or chronic obstructive pulmonary disease (COPD);\n* Abnormal neurological clinical assessment, especially chorea;\n* Use of treatments that may affect immunity in the last four weeks, including immunomodulators, corticosteroids (only systemic use for two weeks or more), or antineoplastic agents;\n* Use of treatments that may affect heart valves in the last four weeks or planned during the study period, including fenfluramine and dexfenfluramine;\n* Renal insufficiency determined by estimated creatinine clearance below 45 ml\u002Fmin\u002F1.73m²;\n* History of intolerance or allergy to any component of the study product, including antigen or adjuvant;\n* Presence of valve abnormalities or alterations in cardiac anatomy as defined by echocardiogram;\n* Altered electrocardiogram;\n* Evidence or suspicion of recent S. pyogenes infection based on clinical symptoms in the last four weeks;\n* Pregnancy, breastfeeding mother, or intention to become pregnant during the study period (only female participants);\n* Any other condition that may interfere with the study process as assessed by the researchers, including sample size and statistical power.","45 Years",{"count":161,"type":21},60,[163,164],"PHASE1","PHASE2","This is a Phase I\u002FIIa, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to test the candidate vaccine StreptInCor. The study will include four different doses (25 µg, 50 µg, 100 µg, and 200 µg) of StreptInCor produced under Good Manufacturing Practices (GMP) and formulated with aluminum hydroxide as the vaccine adjuvant. The adjuvant alone will be used as a placebo in this trial. Five groups, each consisting of twelve healthy adult volunteers, will randomly receive two doses of the vaccine or placebo with a 28-day interval, along with a booster dose six months after the initial vaccination",[27,167,168,169,170,171],"Rheumatic Heart Disease in Children","Vaccine Adverse Reaction","Rheumatic Diseases","Vaccine Acceptance","Vaccine",[173,29,174,175,176],"Acute rheumatic fever","Vaccine development program","Group A streptococcus (GAS)","Streptococcus pyogenes","2025-07-17",{"date":179,"type":35},"2025-07-22",{"date":181,"type":21},"2025-10-01",{"date":183,"type":21},"2028-12-01",{"name":185,"class":42},"University of Sao Paulo General Hospital",{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":17,"sex":18,"minAge":192,"maxAge":136,"enrollmentInfo":193,"targetDuration":4,"studyType":22,"phases":195,"briefSummary":196,"conditions":197,"keywords":198,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":43},"100597975","effectiveness-of-edutainment-based-interventions-in-increasing-knowledge-of-rheumatic-fever-and-rheumatic-heart-disease-among-school-going-children-in-nepal-study-protocol-for-colors-to-save-hearts-quasi-experimental-pretest-posttest-study-100597975","NCT07065474","Effectiveness of Edutainment-Based Interventions in Increasing Knowledge of Rheumatic Fever and Rheumatic Heart Disease Among School-Going Children in Nepal: Study Protocol for Colors to Save Hearts Quasi-Experimental Pretest-Posttest Study","Inclusion Criteria:\n\n* Students will be eligible for inclusion in the study if they are formally enrolled in one of the selected public schools and are studying in grades 6 to 9 during implementation of this study.\n\nExclusion Criteria:\n\n* Students will be excluded from the study if they or their guardians decline to participate or fail to provide the required consent and assent. Students who are absent during both the baseline and post-intervention assessments will also be excluded from the final analysis.","10 Years",{"count":194,"type":21},2400,[24],"Background: Acute rheumatic fever (ARF) and its sequela, rheumatic heart disease (RHD), remain significant public health concerns in low- and middle-income countries, including Nepal. Despite their preventable nature, awareness of ARF and RHD among schoolchildren is limited. Innovative, age-appropriate health education strategies are urgently needed to promote early recognition and prevention.\n\nObjective: This study aims to evaluate the effectiveness of an edutainment-based intervention in improving knowledge of ARF and RHD among school-going children in Nepal.\n\nMethods: A quasi-experimental pretest-posttest study design with a waitlist control group will be employed across 24 public schools in six diverse districts. A total of 2,400 students from Grades 6 to 9 will be included. The intervention integrates creative educational tools-coloring books, activity books, storytelling, videos, and interactive sessions-tailored to different age groups. Knowledge change will be measured using a validated questionnaire administered at baseline and post-intervention. Secondary outcomes include the prevalence of RHD-related symptoms assessed through clinical screening.\n\nExpected Outcomes: It is hypothesized that students in the intervention group will demonstrate a statistically significant improvement in knowledge scores compared to their baseline levels and the control group. The study will also assess the feasibility and acceptability of the intervention and inform recommendations for broader school-based health education programs.\n\nConclusion: This study addresses a critical gap in child health education in Nepal using an innovative, scalable approach. Findings will contribute to the evidence base for integrating edutainment into school curricula to combat preventable diseases like RHD in resource-limited settings.",[27],[199,29,200,201,202],"Colour to Save Hearts","Rheumatic Fever","Health awarness","Youth intervention","2025-07-13",{"date":205,"type":35},"2025-07-15",{"date":207,"type":21},"2025-07-28",{"date":209,"type":21},"2025-11-12",{"name":211,"class":42},"Kathmandu Institute of Child Health",{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":18,"minAge":218,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":139,"phases":4,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":43},"100598218","korea-vhd-echo-study-surveillance-of-aortic-mitral--tricuspid-patients---insights-from-real-world-practice-100598218","NCT07068633","Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice","Inclusion Criteria:\n\n* Period: 2010.1.1\\~2020.12.31\n* Age \\> 18 years\n* Moderate or severe native VHD (AS, AR, MR and TR)\n* Perform echocardiography more than twice\n\nExclusion Criteria:\n\n* Poor image of echocardiography\n* Follow up loss","19 Years",{"count":220,"type":21},30000,"Valvular heart disease (VHD) is a growing public health concern globally, with increasing disease burden and rising interest in advanced treatment strategies such as transcatheter interventions. However, there remains a significant lack of real-world data regarding echocardiography practices, disease prevalence and progression, referral patterns, and treatment pathways. Addressing these gaps is critical for improving patient care and informing clinical decision-making.\n\nSouth Korea provides a unique opportunity to conduct a nationwide retrospective echocardiographic study due to its advanced healthcare infrastructure, high patient volume, and strong tradition in clinical research. The current study aims to evaluate the real-world burden and clinical journey of patients with moderate or severe valvular disease over a 10-year period, based on echocardiographic and electronic medical record (EMR) data collected from multiple tertiary centers across the country.",[223,224,225,226,227,228,27,229],"Heart Valve Diseases","Aortic Valve Stenosis","Aortic Valve Insufficiency","Mitral Valve Insufficiency","Mitral Valve Prolapse","Tricuspid Valve Insufficiency","Aortic Diseases","2025-07-07",{"date":232,"type":35},"2025-07-16",{"date":234,"type":21},"2025-08",{"date":236,"type":21},"2027-12-31",{"name":238,"class":42},"Yonsei University",{"id":240,"slug":241,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":18,"minAge":246,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":139,"phases":4,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":261},"100405193","the-clinical-influence-of-developing-a-sustainable-cardiac-surgery-service-to-reduce-the-burden-of-rheumatic-heart-disease-in-sub-saharan-africa-100405193","NCT04556188","The Clinical Influence of Developing a Sustainable Cardiac Surgery Service to Reduce the Burden of Rheumatic Heart Disease in Sub-Saharan Africa","RHD-CaSS","Inclusion Criteria:\n\n* Cardiac surgery due to rheumatic heart disease at the governmental Black Lion University Hospital during the bi-directional programme of education, training and Research to establish Cardiac surgery service\n\nExclusion Criteria:\n\n* Not willing or able to provide written informed consent","14 Years",{"count":248,"type":21},200,"In this bi-directional program of education, training and research activities based on sustainable development goals aim is to develop cardiac surgery service in Ethiopia.\n\nThe aim is to evaluate the short and long-term outcome of cardiac surgery for rheumatic heart disease in a low-income country compared to individuals not offered cardiac surgery due to limited availability of the service. Second aim is to evaluate the quality of anticoagulant therapy in patients after cardiac surgery for rheumatic heart disease in a low-income country .",[27,251],"Anticoagulant Adverse Reaction","2025-06-11",{"date":254,"type":35},"2025-06-12",{"date":256,"type":35},"2016-03-01",{"date":258,"type":21},"2026-06-30",{"name":260,"class":42},"Helse Nord-Trøndelag HF",4,{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":11,"sex":18,"minAge":136,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":22,"phases":272,"briefSummary":273,"conditions":274,"keywords":276,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":43},"100589281","treating-severe-mitral-valve-annular-or-valvular-calcification-using-shockwave-balloon-smartwave-100589281","NCT06952374","Treating Severe Mitral Valve Annular or Valvular Calcification Using Shockwave Balloon SMARTWAVE","Mitral Valve Lithotripsy Using the SMARTWAVE Balloon for Severe Mitral Annular or Valvular Calcification (SMART-MAC): First in Human Study","SMARTMAC","Inclusion Criteria:\n\n* Age \\>18 and\n* Able to give procedure and study consent and\n* Severe symptomatic mitral stenosis (MVA \\\u003C1.5cm\\^2 derived by 3D planimetry or continuity equation or pressure half time) and\n* Presence of mitral annular calcification or\n* CRHD with severe leaflet calcification with Wilkins score \\>8\n\nExclusion Criteria:\n\n* Baseline \\> moderate MR\n* Intracardiac thrombus as visualized by TEE\n* Pregnant patients. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure.\n* Active infection with bacteremia\n* Current participation in another investigational drug or device study",{"count":271,"type":21},10,[24],"Mitral stenosis (MS) is a heavily symptomatic valvular heart disease. Common causes of MS included chronic rheumatic heart disease (CRHD) and mitral annular calcification (MAC). Current guideline recommends percutaneous balloon mitral valvuloplasty (PBMV) being the first line intervention for rheumatic MS with favorable anatomy. However, severely calcified mitral valve (i.e. those with Wilkins scores\\>8) makes the mitral valve non-pliable and carries high risk of severe mitral regurgitation (MR) (4-19%) with conventional balloon valvuloplasty. MAC is an increasingly recognized disease associated with atherosclerotic risk factors, and a well-recognized valve morphology that responses poorly with PBMV. Besides, conventional open-heart surgery for MAC-associated mitral valve dysfunction carries high mortality. Transcatheter mitral valve replacement with valve-in-MAC has become an alternative in treating these patients. However, valve-in-MAC is not always feasible and still carries operative and 30-day mortality.\n\nIntravascular lithotripsy is an approved adjunct interventional therapy in treating calcified lesions to facilitate stenotic lesion opening in peripheral vascular disease and coronary artery disease. The off-label use of current peripheral lithotripsy balloon in mitral valve as a compassionate treatment or as an adjunct treatment before mitral balloon valvuloplasty and transcatheter mitral valve replacement has been reported with success . A possible mechanism is that lithotripsy preferentially impacts hard tissue, disrupts calcium, and leaves soft tissue undisturbed, improving valve pliability, preventing leaflet damage, and making subsequent valvuloplasty safer. However, the off-label use of multiple peripheral lithotripsy balloons in mitral valve is technically complicated.\n\nSmartWave balloon was specifically designed lithotripsy balloon for calcified aortic stenosis. This first-in-human study aims to apply the SmartWave lithotripsy balloon in treating calcified mitral stenosis due to MAC or severely calcified rheumatic mitral valve.",[275,27],"Mitral Annulus Calcification",[277],"Mitral valve stenosis","2025-04-23",{"date":280,"type":35},"2025-04-30",{"date":282,"type":35},"2025-03-08",{"date":284,"type":21},"2027-03-31",{"name":286,"class":42},"Prince of Wales Hospital, Shatin, Hong Kong",{"id":288,"slug":289,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":293,"eligibilityCriteria":294,"healthyVolunteers":17,"sex":18,"minAge":192,"maxAge":295,"enrollmentInfo":296,"targetDuration":4,"studyType":139,"phases":4,"briefSummary":298,"conditions":299,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":43},"100515416","screening-and-secondary-prevention-rheumatic-heart-disease-study-100515416","NCT05991219","Screening and Secondary Prevention Rheumatic Heart Disease Study","Screening and Secondary Prevention Rheumatic Heart Disease","S2-RHD","Inclusion Criteria:\n\n* Rural communities in Sindh\n\nExclusion Criteria:\n\n* Refused to participate in the study","30 Years",{"count":297,"type":21},5000,"After basic clinical screening including history and physical, Point of care ultrasound will be performed to look at Mitral, Aortic and Tricuspid Valves for regurgitation or stenosis. For patients with confirmed Rheumatic heart disease (RHD), treatment and referral depending on stage of disease. Antibiotic prescription could be shifted to community health workers delivering preventive medications via practical clinical algorithms, diagnostic tools, availability of appropriate antibiotics, and supportive supervision. Patients will have repeat imaging at 2 years and 5 years to look at the outcome of delayed progression of valve disease.",[27],"2023-08-12",{"date":302,"type":35},"2023-08-15",{"date":304,"type":35},"2022-09-26",{"date":306,"type":21},"2028-12-31",{"name":308,"class":42},"National Institute of Cardiovascular Diseases, Pakistan",{"id":310,"slug":311,"hasResults":11,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":315,"eligibilityCriteria":316,"healthyVolunteers":17,"sex":18,"minAge":51,"maxAge":317,"enrollmentInfo":318,"targetDuration":4,"studyType":22,"phases":320,"briefSummary":321,"conditions":322,"keywords":323,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":43},"100478050","effectiveness-of-a-school-centered-prevention-program-on-prevalence-of-latent-rheumatic-heart-disease-100478050","NCT05504928","Effectiveness of a School-centered Prevention Program on Prevalence of Latent Rheumatic Heart Disease","Effectiveness of a School-centered Primary and Secondary Prevention Program on Prevalence of Latent Rheumatic Heart Disease","NEPAL4","Inclusion Criteria:\n\n* Age 5-16 years\n* Attending Tulsi Secondary Boarding School in Tulsipur, Nepal.\n\nExclusion Criteria:\n\n* Children \u002F primary caregivers not providing informed consent to participate\n* Children not attending Tulsi Secondary Boarding School in Tulsipur.","16 Years",{"count":319,"type":21},2300,[24],"The overall objective is to evaluate the effectiveness of a school-centered primary and secondary prevention program on the prevalence of latent rheumatic heart disease among schoolchildren in Nepal, and to investigate the role of socioeconomic and environmental factors in the development and progression of rheumatic heart disease.",[27,167],[27,324,325,326],"Primary Prevention","Secondary Prevention","Screening","2022-08-15",{"date":329,"type":35},"2022-08-17",{"date":331,"type":35},"2022-06-01",{"date":333,"type":21},"2026-12-01",{"name":335,"class":42},"Insel Gruppe AG, University Hospital Bern"]