[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"valvular-heart-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:valvular-heart-diseases":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,88,117],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100638188","improving-management-and-secondary-prevention-through-azithromycin-comparative-trial-in-rheumatic-heart-disease-in-nigeria--impact-rhd-nigeria-100638188",false,"NCT07625228","Improving Management and Secondary Prevention Through Azithromycin Comparative Trial in Rheumatic Heart Disease in Nigeria)- IMPACT-RHD Nigeria","Oral Azithromycin Versus Intramuscular Penicillin for Secondary Prevention of Rheumatic Heart Disease in Nigerian Secondary School Students: A Comparative Study to Improve Outcomes in Rheumatic Heart Disease Management","IMPACT-RHD","Inclusion Criteria:\n\n* They must be between 10 and 18 years old and have a confirmed diagnosis of mild or moderate RHD.\n* They must be under follow-up care at one of the four trial sites and be capable of attending monthly visits or be picked during routine secondary school screening to be performed as part of the study.\n* At enrollment, patients must demonstrate cognitive capacity to consent (or assent, if a minor) and a willingness to adhere to the study schedule.\n* Females of childbearing potential must agree to avoid pregnancy during the trial.\n* Individuals must not have initiated any alternative RHD prophylaxis regimen before enrollment; the trial will provide all prophylaxis during the study\n\nExclusion Criteria:\n\n* known allergy to penicillin or any history of anaphylaxis to antibiotics.\n* Girls who are pregnant or breastfeeding will be excluded, as well as any patient with severe comorbidities likely to complicate prophylaxis or follow-up. For example, patients with advanced heart failure (NYHA class III-IV), significant chronic kidney or liver disease, uncontrolled diabetes, or other serious chronic illnesses (e.g. active tuberculosis, immunodeficiency).\n* Patients with psychiatric conditions or cognitive impairment that preclude informed consent or reliable adherence will also be excluded.\n* Any patient currently enrolled in another interventional trial, or who is unwilling or unlikely to comply with monthly visits, will be excluded.","ALL","10 Years","18 Years",{"count":21,"type":22},474,"ESTIMATED","INTERVENTIONAL",[25],"NA","Background: Nigeria, among other Low and Middle-income countries, bears one of the highest burdens of RHD in Africa, affecting young to middle-aged adults within their productive years. This leads to loss of productivity, high out-of-pocket costs, and increased mortality risk. Challenges such as such as poverty, overcrowding, limited antibiotic access, and inconsistent prophylaxis contribute to the persistence of the disease. Secondary prophylaxis using intramuscular Benzathine Penicillin G (BPG) serves as the current standard for prevention, but has demonstrated poor adherence due to injection pain, fear, physical, and socioeconomic constraints. Oral Azithromycin offers a potential alternative by overcoming these barriers, providing an effective, acceptable, affordable and sustainable preventive strategy in Nigeria.\n\nMethods and design: A randomised, non-inferiority, open-label, controlled clinical trial conducted across cardiology clinics of four tertiary hospitals in major Nigerian cities, for a duration of 24 months. This study will recruit participants aged 15 to 45 years with mild to moderate RHD cases (stage A or B as defined by World Heart Federation criteria) confirmed by a blinded adjudication panel, comprising 5 expert cardiologists, who will determine the echocardiographic stage of RHD on enrollment and at completion of the study period. Randomisation of participants will be done in a 1:1 ratio to receive either the standard regimen of intramuscular BPG (1.2 million units) every 28 days or a 3-day course of oral Azithromycin (500mg daily) repeated monthly. A total sample size of 474 participants will provide 90% power to demonstrate non-inferiority, using a margin of 4% with allowance for 15% on follow-up losses.\n\nObjectives: The proportion of participants in the oral Azithromycin arm versus the IM BPG arm who demonstrate echocardiographic progression to worsen RHD stages or experience a recurrence of Acute Rheumatic Fever (ARF) within the period of two years will be compared. Additionally, accessing the adherence rates, causes of RHD-related hospitalisations, safety profiles, cost-effectiveness, and patient-reported outcomes, including treatment satisfaction and Health-Related Quality of Life (HRQoL).\n\nSignificance: This trial is designed to highlight the most effective and readily adoptable secondary prevention strategy for Nigeria's young-to-middle-aged population by evaluating patients' adherence, ease of administration, safety profile, drug availability, cost effectiveness, and other practical considerations in resource-limited settings. Establishing a prevention strategy that addresses the socioeconomic, physical barriers of injection-based prophylaxis and improving long-term adherence and clinical outcomes in Nigeria.",[28,29,30],"Rheumatic Fever","Valvular Heart Diseases","Valvular Cardiomyopathy",[32,33,34,35],"secondary prevention","Rheumatic Valvular Heart Disease","Benzathine Penicillin","Azithromycin","NOT_YET_RECRUITING","2026-06-01",{"date":39,"type":40},"2026-06-04","ACTUAL",{"date":42,"type":22},"2027-01-05",{"date":44,"type":22},"2031-12-30",{"name":46,"class":47},"Ladoke Akintola University of Technology, Ogbomoso, Nigeria","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":68,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":4},"100623450","screening-for-cardiac-and-cardiac-associated-pathology-using-single-channel-electrocardiogram-100623450","NCT07396792","Screening for Cardiac and Cardiac-associated Pathology Using Single-channel Electrocardiogram","Screening for Cardiac and Cardiac-associated Pathology Using Single-channel Electrocardiogram Analyzed With Machine Learning Models","Inclusion Criteria:\n\n1. The presence of written informed consent of the patient to participate in the study\n2. Availability of examination data allowing for the verification or exclusion of cardiac and cardiac-associated pathology\n3. Age 18 years old and older\n\nNon-inclusion criteria:\n\n1. Patients with an implanted permanent pacemaker;\n2. ECG changes that prevent spectral analysis;\n3. Conditions that may impair the quality of the ECG recording (Parkinson's disease, essential tremor, etc.);\n4. Conditions that make ECG recording in lead I impossible (congenital anomalies of the upper limbs, traumatic amputation of the upper limbs).\n5. Lack of written informed consent from the patient to participate in the study.\n\nExclusion Criteria:\n\n1. Poor quality of the ECG recording on a single-channel ECG monitor\n2. Insufficient examination data to verify or exclude cardiac or cardiac-associated pathology;\n3. Patient's unwillingness to continue participating in the study for any reason.",true,{"count":57,"type":22},4000,"OBSERVATIONAL","It is a prospective, controlled, single-center, observational, non-randomized study. The study is planned to include at least 4000 patients 18 years old and older in the training sample and 1000 patients over 18 years old in the test sample (the total number of patients is at least 5000 people). Patients will be included in the study if they have undergone a full examination (laboratory, clinical and instrumental), allowing for the verification or exclusion of cardiac and cardiac-associated pathology in accordance with current recommendations. During the course of the study, the authors of the work do not interfere with the above-mentioned scope of the examination, which is carried out on patients in accordance with clinical guidelines. All patients included in the study will undergo ECG recording in standard lead I for 1 minute twice, followed by spectral analysis of the obtained data, which will be stored at the remote monitoring center of Sechenov University without being linked to the personal data of patients. A spectral analysis of the electrocardiogram will be performed using a continuous wavelet transform. The result of this study will be the identification of ECG parameters that will correlate with cardiac and cardiac-associated pathology",[61,62,29,63,64,65,66,67],"Arterial Hypertension","Heart Rhythm Disorders","Heart Failure","Diabetes Mellitus","Chronic Kidney Disease (Stage 3-4)","Metabolic Syndrome","Coronary Artery Disease",[69,70,71,72,73,74,75,76,77,78],"Screening","Electrocardiogramm","single-channel electrocardiogram","machine learning models","Coronary artery disease","diabetes mellitus","metabolic syndrome","anemia","hypercholesterolemia","arterial hypertension","2026-04-13",{"date":81,"type":40},"2026-04-16",{"date":83,"type":22},"2026-04-01",{"date":85,"type":22},"2028-05-13",{"name":87,"class":47},"I.M. Sechenov First Moscow State Medical University",{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":116},"100632627","robotic-transjugular-transcatheter-tricuspid-valve-replacement-100632627","NCT07516145","Robotic Transjugular Transcatheter Tricuspid Valve Replacement","Robotic Lux","Inclusion Criteria:\n\n* Age 18-90\n* Severe symptomatic TR\n* Deem high risk for tricuspid valve surgery determined by a multidisciplinary heart team (including cardiologists, cardiac surgeons and cardiac anesthetists) and\n* Anatomically feasible for transjugular transcatheter tricuspid valve replacement using the Lux-valve plus system\n* Able to consent\n\nExclusion Criteria:\n\n* Prior TV repair or replacement that would interfere with Lux-valve plus implantation\n* severe pulmonary hypertension (pulmonary artery systolic pressure \\>70 mm Hg or \\>2\u002F3 systemic with pulmonary vascular resistance \\>5 WU after vasodilator challenge)\n* Pregnant or nursing patients and those who plan pregnancy during the study period. Female patients of childbearing potential must have a negative pregnancy\n* Left Ventricular Ejection Fraction (LVEF) \\\u003C40% or;\n* Evidence of intracardiac mass, thrombus or vegetation or;\n* Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT or;\n* Surgical correction is indicated for other concomitant valvular disease (e.g., severe aortic, mitral and\u002For pulmonic valve stenosis and\u002For regurgitation); Subjects with concomitant valvular disease may treat their respective valve first and wait 2 months before being reassessed for the trial.\n* Sepsis or active endocarditis within 3 months, or infections requiring antibiotic therapy within 2 weeks prior to the planned procedure or;\n* Active peptic ulcer or active gastrointestinal (GI) bleeding precluding anticoagulation or antiplatelet therapy or;\n* Underwent any cardiac or non-cardiac interventional or surgical procedure within 30 days prior to the procedure or planned to have the interventional or surgical procedure within 60 days after implant procedure (e.g., cardioversion, ablation, percutaneous coronary intervention, etc);\n* Recent (within 90 days prior to procedure) stroke, transient ischemic attack, or myocardial infarction;\n* Life expectancy is less than 1 year;\n* Current participation in another investigational drug or device study.","90 Years",{"count":97,"type":22},10,[25],"Valvular heart disease (VHD), caused by abnormalities in heart valves, can lead to severe complications such as heart failure and death, with approximately 220 million affected patients worldwide. The prevalence of VHD continues to grow alongside the aging global population. Transcatheter heart valve interventions have emerged as minimally invasive alternatives, offering benefits like shorter recovery times and reduced discomfort. However, current manual catheter-based techniques are complex, highly dependent on clinicians' expertise, and involve significant physical risk due to prolonged exposure to X-ray radiation and cumbersome protective gear.\n\nTo address these challenges, a novel, universal intracardiac robotic system is proposed to improve precision, safety, and procedural efficiency. This system integrates a high-dexterity, load-capacity catheter instrument, a modular concentric robotic platform, and an augmented reality (AR) navigation interface. The catheter's design balances flexibility for navigating complex intracardiac paths with the rigidity needed for device deployment. The robotic platform's modular architecture enhances versatility, enabling control across various procedures and anatomical variations, while the AR system facilitates intuitive preoperative planning and real-time intraoperative guidance through multimodal image fusion.\n\nThe core innovation lies in overcoming existing limitations: balancing catheter flexibility and load capacity, expanding robotic system adaptability for different valve procedures, and improving integration with imaging modalities like computed tomography, transesophageal echocardiogram, and fluoroscopy. The project aims to develop sophisticated models for instrument design, control strategies for multi-instrument coordination, and advanced navigation tools. These technological advancements are intended to elevate the clinical utility of robotic intracardiac interventions, making them safer, more efficient, and easier to adopt widely. By establishing a systematic approach for intelligent, multimodal, robotic-assisted valvular procedures, this work promises significant contributions to minimally invasive cardiology and holds substantial potential for clinical translation.",[101,29,102],"Tricuspid Regurgitation (TR)","Transcatheter Valve Replacement",[104,105,102],"Tricuspid Regurgitation","Valvular heart diseases","RECRUITING","2026-03-31",{"date":109,"type":40},"2026-04-07",{"date":111,"type":40},"2026-03-12",{"date":113,"type":22},"2028-03-31",{"name":115,"class":47},"Prince of Wales Hospital, Shatin, Hong Kong",1,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":23,"phases":128,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":116},"100614792","clear-trial-ca330-cytokine-adsorption-column-for-anticoagulantantiplatelet-patients-in-non-elective-cpb-surgery-100614792","NCT07284199","CLEAR Trial: CA330 Cytokine Adsorption Column for Anticoagulant\u002FAntiplatelet Patients in Non-Elective CPB Surgery.","A Multicenter Randomized Controlled Trial of the CA330 Haemoadsorption Device in Patients for Limiting Excess Anticoagulation in Non-elective caRdiac Surgery With Cardiopulmonary Bypass","CLEAR","Inclusion Criteria:\n\n* Patients scheduled to undergo non-elective cardiovascular surgery requiring cardiopulmonary bypass;\n* Patients currently receiving one or more of the following medications - indobufen, ticagrelor, warfarin, cilostazol, dabigatran, rivaroxaban, or apixaban - with the last dose administered within the drug washout period.\n\nExclusion Criteria:\n\n* Patients with a history of chronic liver failure, stage 5 chronic kidney disease (CKD5), or requiring regular dialysis;\n* Patients in special physiological states: pregnancy or puerperium;\n* Patients with advanced-stage malignancy or scheduled cardiovascular surgery related to tumor management;\n* Patients with allergic reactions to cytokine adsorption column resin or related components;\n* Patients with known bleeding risk due to hematologic disorders such as heparin-induced thrombocytopenia, hemophilia, or acute sickle cell crisis;\n* Patients with severe infection, including severe sepsis.","80 Years",{"count":127,"type":22},120,[25],"The goal of this clinical trial is to evaluate whether the CA330 cytokine adsorption column can reduce perioperative severe bleeding adverse events in patients receiving anticoagulant and\u002For antiplatelet therapy who undergo non-elective cardiac surgery with cardiopulmonary bypass.\n\nThe main questions it aims to answer are:\n\n* Does the use of the CA330 cytokine adsorption column lower the incidence of perioperative severe bleeding compared with standard care?\n* Does the intervention improve short-term clinical outcomes, such as transfusion requirements, reoperation rates for bleeding, or overall postoperative recovery?\n\nIf there is a comparison group: Researchers will compare patients treated with the CA330 cytokine adsorption column versus patients receiving standard cardiopulmonary bypass management to see if cytokine adsorption provides additional safety and efficacy benefits.\n\nParticipants will:\n\n* Undergo non-elective cardiac surgery requiring cardiopulmonary bypass.\n* Be randomly assigned to receive either the CA330 cytokine adsorption column integrated into the CPB circuit (intervention arm) or standard CPB management without the device (control arm).\n* Be monitored for perioperative bleeding outcomes, transfusion needs, reoperation rates, and overall postoperative prognosis.",[131,132,29],"CABG","Aortic Dissection","2025-12-14",{"date":135,"type":40},"2025-12-16",{"date":137,"type":22},"2025-12-15",{"date":139,"type":22},"2028-06-30",{"name":141,"class":47},"Beijing Anzhen Hospital"]