[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Prince of Wales Hospital, Shatin, Hong Kong\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":278},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,46,74,98,121,145,168,186,208,233,257],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100632627","robotic-transjugular-transcatheter-tricuspid-valve-replacement-100632627",false,"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.","ALL","18 Years","90 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27,28,29],"Tricuspid Regurgitation (TR)","Valvular Heart Diseases","Transcatheter Valve Replacement",[31,32,29],"Tricuspid Regurgitation","Valvular heart diseases","RECRUITING","2026-03-31",{"date":36,"type":37},"2026-04-07","ACTUAL",{"date":39,"type":37},"2026-03-12",{"date":41,"type":21},"2028-03-31",{"name":43,"class":44},"Prince of Wales Hospital, Shatin, Hong Kong","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":4},"100627969","lambre-ii-left-atrial-appendage-occluder-and-occluder-delivery-system-for-patients-with-non-valvular-atrial-fibrillation-100627969","NCT07455539","LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System for Patients With Non-Valvular Atrial Fibrillation","A First-in-Man (FIM) Study of the LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System for Patients With Non-Valvular Atrial Fibrillation","LAmbre2","Inclusion Criteria:\n\n* The patient age ≥18 years;\n* The patient has documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation;\n* The patient has a CHA2DS2-VASc score of ≥ 2 in men and CHA2DS2-VASc score of ≥ 3 in women;\n* The patient is recommended for oral anticoagulation therapy, but there is an appropriate rationale for seeking a non-pharmacologic alternative to oral anticoagulation;\n* The patient is deemed suitable for LAA closure by the site investigator and a clinician not a part of the procedural team in the shared decision-making process, and this determination has been documented in the patient's medical record;\n* The patient is willing and able to comply with the required medication post-procedure and follow-up evaluations;\n* The patient (or his or her legally authorized representative) has been informed of the nature of the study, agrees to its provisions, and has been provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC).\n\nExclusion Criteria:\n\n* 1\\. Pregnant or nursing patients and those who plan pregnancy during the study period. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to the index procedure;\n* Patients with atrial fibrillation that is defined by a single occurrence, or that is transient or reversible (e.g., secondary to CABG, an interventional procedure, pneumonia, or hyperthyroidism);\n* Patients who require long-term anticoagulation for a condition other than atrial fibrillation;\n* Bleeding diathesis or coagulopathy;\n* Patients with rheumatic mitral valve disease, known severe mitral stenosis requiring surgical or percutaneous valve replacement, or existing mechanical valve prosthesis;\n* Active infection with bacteremia;\n* Known hypersensitivity or contraindication to aspirin, clopidogrel, heparin, any device material or component (nickel titanium, PET, polypropylene), and\u002For contrast sensitivity;\n* Prior atrial septal defect (ASD) or patient foramen ovale (PFO) surgical repair or implantation of closure device;\n* Left atrial appendage is obliterated and surgical ligated;\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, cataract surgery, etc.);\n* Recent (within 90 days prior to procedure) stroke, transient ischemic attack, or myocardial infarction;\n* New York Heart Association Class IV;\n* Patients with severe renal failure (estimated glomerular filtration rate\\\u003C30 ml\u002Fmin\u002F1.73m2);\n* Known asymptomatic carotid artery disease with\\>70% diameter stenosis OR symptomatic carotid disease (\\>50% diameter stenosis with ipsilateral stroke or TIA). Subjects with prior carotid endarterectomy or carotid stent placement may be enrolled, provided that known diameter stenosis is \\\u003C50%;\n* Life expectancy is less than 1 year;\n* Current participation in another investigational drug or device study.\n\nEchocardiographic Exclusion Criteria:\n\n* Left atrial appendage anatomy cannot accommodate the LAmbre II LAA Occluder per manufacturer IFU;\n* LVEF \\\u003C30%;\n* Intracardiac thrombus or dense spontaneous echo contrast, as visualized by TEE prior to implant;\n* Presence of a high-risk patent foramen ovale (PFO), defined as an atrial septal aneurysm (excursion \\>15 mm or length \\>15 mm) or large shunt (early, within 3 beats and\u002For substantial passage of 20 bubbles);\n* Existing circumferential pericardial effusion \\>5 mm;\n* Moderate or severe mitral valve stenosis (mitral valve area \\\u003C1.5 cm2);\n* Complex atheroma with mobile plaque of the descending aorta and\u002For aortic arch;\n* Presence of a cardiac tumor",{"count":20,"type":21},[24],"Worldwide, atrial fibrillation (AF) is the most common cardiac arrhythmia in adults. The prevalence of AF gradually increases with age; its prevalence is 0.5% \\~ 0.8% among 45 \\~ 59 year-olds, 1.8% \\~ 5.9% among 60 \\~ 69 year-olds, and 6.7% \\~17.9% among \\> 79 year-olds. Thromboembolic complications are the leading cause of death and disability in patients with AF, with ischemic stroke being the most common complication. AF significantly increases the risk of stroke by 3- to 5-fold due to thrombosis caused by abnormal atrial beat. The overall risk of ischemic stroke in patients with AF is 20% \\~ 30%, and strokes due to atrial fibrillation account for 20% of all strokes.\n\nIn the current 2023 ACC\u002FAHA\u002FACCP\u002FHRS Guideline, percutaneous LAAC has been classified as a Class 2a indication for stroke prevention in patients with AF, a moderate to high risk of stroke, and a contraindication to long-term oral anticoagulation due to a nonreversible cause. However, the implantation procedure does have adverse effects which include serious pericardial effusion, procedure-related ischemic stroke, and device embolization. Due to the anatomical diversity of the LAA, certain patients are not candidates for this device.\n\nThe LAmbre™ Left Atrial Appendage Closure System, manufactured by Lifetech Scientific (Shenzhen) Co.Ltd., is the first generation of LAmbre LAAO device which is CE-marked and is current approved in Hong Kong Hospital Authority for regular clinical use. It consists of a LAA Occluder and a Delivery System and is a percutaneous transcatheter device intended to prevent thrombus embolization from the left atrial appendage in patients who have nonvalvular atrial fibrillation.\n\nThis self-expanding LAA Occluder consists of an umbrella and a cover connected by a central waist. Although the first generation of LAmbre LAAO device is associated with high implantation success rate of 99.7% and a relatively low major procedure-related complication rate of 2.9%, to better match the challenging anatomy of the LAA and to further improve procedural safety, the first generation of LAmbre LAAO device has been upgraded.\n\nThe LAmbre™ II Left Atrial Appendage Occluder, designed to prevent thrombus embolization and reduce the risk of bleeding events in patients with non-valvular atrial fibrillation, is being evaluated in a prospective, single-center, single-arm First In Man (FIM) study. The study, conducted at the Prince of Wales Hospital, Chinese University of Hong Kong, aims to assess the preliminary safety and feasibility of the device and its Occluder Delivery System in 10 subjects who are at increased risk for stroke and systemic embolism, either due to their anticoagulation therapy eligibility or contraindications.\n\nThe enrollment period is expected to take approximately 6 months and subjects will have follow-up before discharge and at 30 days, 3M, 6M, 12M months post-operation. The total study duration is expected to be approximately 19 months.",[58],"Non Valvular Atrial Fibrillation",[60,61,62,63,64],"non valvular atrial fibrillation","Left Atrial Appendage","Left Atrial Appendage Occluder","Left Atrial Appendage Occlusion","Stroke prevention","NOT_YET_RECRUITING","2026-03-02",{"date":68,"type":37},"2026-03-06",{"date":70,"type":21},"2026-04-01",{"date":72,"type":21},"2028-05-01",{"name":43,"class":44},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":95,"leadSponsor":97,"locationsCount":45},"100617793","hong-kong-cardiogenic-shock-initiative-100617793","NCT07323238","Hong Kong Cardiogenic Shock Initiative","HK CSI","Inclusion Criteria:\n\n* Diagnosis of acute myocardial infarction (AMI) with the ECG and\u002For biomarker evidence of S-T elevation myocardial infarction (STEMI) or non -S-T elevation myocardial infarction (NSTEMI)\n* Cardiogenic Shock is defined as presence of at least two of the following\n\n  1. Hypotension (systolic blood pressure ≤ 100 mmHg, or inotropes\u002Fvasopressors to maintain systolic blood pressure ≥ 100 mmHg)\n  2. Evidence of end organ perfusion: elevated serum lactate levels (venous or arterial), cool extremities, oliguria\u002Fanuria\n  3. Hemodynamic criteria represented by cardiac index of \\\u003C2.2 L\u002Fmin\u002Fm² or a cardiac ≤ 0.6 watts\n* Patient is supported with a transvalvular MCS as the initial device (criteria for GCSI-eligible Cohort)\n* Patients undergo PCI within 12 hours of hospital presentation (criteria for GCSI-eligible Cohort)\n* Subject or legally designated representative (LDR) has provided written informed consent. For patients not able to provide consent, data collection will be conducted in retrospective manner with study consent waived.\n\nExclusion Criteria:\n\n* Unwitnessed out of hospital cardiac arrest or any cardiac arrest in which return of spontaneous circulation (ROSC) is not achieved within 20 minutes\n* Patients demonstrate any signs of anoxic brain injury prior to the INDEX PCI (signs of anoxic injury include, posturing, seizures).\n* IABP placed prior to MCS (criteria for GCSI-eligible Cohort)\n* Septic, anaphylactic, hemorrhagic, and neurologic causes of shock\n* Non-ischemic causes of shock\u002Fhypotension (pulmonary embolism, pneumothorax, myocarditis, tamponade, etc.)\n* Active bleeding for which MCS in contraindicated\n* Recent major surgery for which MCS is contraindicated\n* Mechanical complication of AMI (acute ventricular septal defect (VSD) or acute papillary muscle rupture)\n* Known left ventricular thrombus for which MCS in contraindicated (criteria for GCSI-eligible Cohort)\n* Mechanical aortic prosthetic valve (criteria for GCSI-eligible Cohort)\n* Contraindication to intravenous systemic anticoagulation which precludes placement of MCS.\n\nPatients who fulfills all Eligibility Criteria would be recruited and considered GSCI-eligible. AMI-CS patients that did not use MCS, ie. Not fulfiliing both Inclusion Criteria 3, 4, would not be considered screen failure and would still be screened and recruited into HKCSI GCSI-ineligible cohort. Likewise, patients who meet any of Exclusion Criteria will not be GCSI-eligible. Specifically, patients who met exclusion criteria 3, 9, 10 only will be recruited into GCSI-ineligible cohort.",{"count":82,"type":21},320,"OBSERVATIONAL","Acute myocardial infarction complicated by cardiogenic shock (AMI-CS) is a severe condition with high mortality. Early revascularization and Impella device (Abiomed) support improve outcomes. Observational studies like the National Cardiogenic Shock Initiative (NCSI), Inova-Shock registry, and J-PVAD (Japan registry for percutaneous ventricular assist device) registry emphasize the importance of structured care systems when using mechanical circulatory support (MCS).\n\nFollowing the release of the Danger Shock trial, MCS use is expected to rise. Hospitals will need to monitor practices and work with payers to ensure coverage. Using regional real-world data can assist this process, making the collection and analysis of MCS outcomes essential.\n\nThe NCSI (NCT03677180) aimed to evaluate outcomes with a protocolized approach prioritizing rapid diagnosis, timely MCS delivery, and invasive hemodynamic monitoring via pulmonary artery (PA) catheters. The study involved 406 patients from 2016 to 2020, with an average age of 64 years. Most (67%) had shock, with 85% on vasoactive drugs. Witnessed outof-hospital cardiac arrest occurred in 17%, and in-hospital arrest in 30%. During MCS implantation, 9% were actively resuscitating. Patients mostly in SCAI stage C\u002FD (73%) and stage E (27%) presented with low blood pressure, high lactate, and reduced cardiac power output. About 70% received MCS before PCI, with 90% using PA catheters. Most had STEMI, with median door-to-support and door-to-balloon times of about 78 and 81 minutes. Survival rates were high: 99% procedural, 79% to discharge, 77% at 30 days, and 62% at one year for stage C\u002FD shock. Patients with stage E shock had lower survival. Early use of MCS improved hemodynamics and survival. Further research, like the CERAMICS (Can Escalation Reduce Acute Myocardial Infarction in Cardiogenic Shock) study, aims to refine escalation strategies. The Danger Shock trial highlighted the importance of minimizing complications such as bleeding, limb ischemia, haemolysis, and kidney injury.\n\nCurrently in Hong Kong, prevalence of CS among AMI patients is 5-10%, in-line with global statistics. Among which, 30-day and 1-year mortality of AMI-CS patients in Hong Kong was reported at 29% and 39.5% respectively. Although the use of MCS has been shown in the above overseas studies to improved survival rates of AMI-CS patients, the utilisation rate of MCS among AMI-CS patients in Hong Kong was reported at 36.5% in a previous single-centre study, limited by an array of factors including limited device availability, allocations of resources and patient selection strategy, lack of region-specific evidence and device affordability. Global Cardiogenic Shock Initiative (GCSI) is an ongoing international multicenter registry involving centers from USA, Germany, and Hong Kong, and focus on the outcomes of AMI-CS patients received Impella support. The GCSI is expanding to many other regions. In the Hong Kong Cardiogenic Shock Initiative (HK-CGSI) study we aim to include sites with experience in MCS, all of whom have the capability of MCS escalation and evaluate outcomes across these centers.\n\nThe goal is not only to capture the effects of previously established best practices but gain insights into regional best practices, and together with data from the global cardiogenic shock initiative (GCSI), to better establish the adoption of novel best practices and their effect on complication rates.\n\nIn parallel to GCSI-eligible cohort, i.e. Impella used as the first supporting device for patients with AMI-CS, given the significant portion of patients who could not receive MCS under current limitations in Hong Kong, in the HK-CSI, we will include also the GCSI-ineligible cohort, i.e. AMI-CSI without using Impella or not as the first MCS used, to understand the full picture of clinical outcomes of AMI-CS patients of Hong Kong.\n\nThe HK-CSI study is an observational registry solely and not a treatment study. This single-arm registry captures data generated during procedures which are considered standard of care. Participation in this registry will be performed with waiver of consent of the patient and will have no influence on the type and extent of treatment.",[86,87,88,89,90],"Cardiogenic Shock Acute","STEMI - ST Elevation Myocardial Infarction","Cardiogenic Shock","Cardiogenic Shock Post Myocardial Infarction","Mechanical Circulatory Support","2026-01-07",{"date":93,"type":37},"2026-01-09",{"date":70,"type":21},{"date":96,"type":21},"2030-10-02",{"name":43,"class":44},{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":4,"enrollmentInfo":106,"targetDuration":108,"studyType":83,"phases":4,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":45},"100615700","the-asia-pacific-mitral--tricuspid-valve-in-valvevalve-in-ring-registry-100615700","NCT07296016","The Asia-Pacific Mitral & Tricuspid Valve-in-Valve\u002FValve-in-Ring Registry","AP ViV","Inclusion Criteria:\n\n1. Age ≥ 21\n2. Had at least one documented Mitral valve-in-valve\u002Fvalve-in-ring procedure done during the period of 1 Jan 2023 to current date. (Retrospective) OR Planned to undergo a Mitral valve-in-valve\u002Fvalve-in-ring procedure. (Prospective) OR Had at least one documented Tricuspid valve-in-valve\u002Fvalve-in-ring procedure done during the period of 1 Jan 2023 to current date. (Retrospective) OR Planned to undergo a Tricuspid valve-in-valve\u002Fvalve-in-ring procedure. (Prospective)\n\nExclusion Criteria:\n\n1. Active endocarditis\n2. Any other conditions which investigator deems unsuitable for participation.","21 Years",{"count":107,"type":21},15,"10 Years","A significant number of patients with severe mitral and tricuspid valve disease have been previously treated with either valve repair with annuloplasty rings or valve replacement with bioprosthetic\u002Fmechanical valves. Over time, these bioprosthetic valves and rings may fail resulting in recurrence of the valvular disease. The technical aspects of a re-do operation are complex and these patients are often times at high risk for repeat open surgery. The emergence of transcatheter options may provide a safer and less invasive alternative to open surgery. Majority of the data currently exist for Western cohorts with limited longer-term outcomes. Data on this therapy is particularly lacking in the Asia-Pacific region, especially important in the light of known differences in body habitus and size.",[111,112],"Structural Heart Disease","Mitral Valve Regurgitation","2025-12-16",{"date":115,"type":37},"2025-12-22",{"date":117,"type":21},"2026-01-05",{"date":119,"type":21},"2035-12-31",{"name":43,"class":44},{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":128,"targetDuration":130,"studyType":83,"phases":4,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":142,"leadSponsor":144,"locationsCount":45},"100612748","left-atrial-appendage-occlusion-in-dialysis-patients-with-atrial-fibrillation-a-multicentre-pilot-study-100612748","NCT07257614","Left Atrial Appendage Occlusion in Dialysis Patients With Atrial Fibrillation: A Multicentre Pilot Study","LAAO-DAF","Inclusion Criteria:\n\n* Age \\>=18\n* End stage renal failure on peritoneal dialysis or haemodialysis\n* documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation;\n* CHADS2-VASc \\>=2\n* The patient is willing and able to comply with the required medication post-procedure and follow-up evaluations;\n* Able to consent\n\nExclusion Criteria:\n\n* Patients who require long-term anticoagulation for a condition other than AF, e.g. pulmonary embolism, deep vein thrombosis, anti-phospholipid syndrome\n* Mechanical valve replacement\n* Active infection with bacteraemia;\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* Known hypersensitivity or contraindication to aspirin, clopidogrel, heparin, any device material or component (nickel titanium, PET, polypropylene), and\u002For contrast;\n* Left atrial appendage is obliterated and surgical ligated;\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* New York Heart Association Class IV;\n* Life expectancy is less than 1 year;\n* Current participation in another investigational drug or device study.\n* Echocardiogram exclusion:\n\n  i. Moderate mitral stenosis or above ii. LVEF \\\u003C30% iii. Intracardiac thrombus iv. Presence of a cardiac tumour. v. Existing circumferential pericardial effusion \\>5 mm; vi. Presence of a high-risk Patent Foramen Ovale (PFO), defined as an atrial septal aneurysm (excursion \\>15 mm or length \\>15 mm) or large shunt (early, within 3 beats and\u002For substantial passage of 20 bubbles)",{"count":129,"type":21},40,"1 Year","Objectives: This pilot study aims to evaluate the safety and efficacy of left atrial appendage occlusion (LAAO) in dialysis patients and atrial fibrillation (AF) to establish a novel stroke prevention strategy and determine an optimal post-occlusion antithrombotic regime. Page 3 of 50 Hypothesis: The study tests the hypotheses that LAAO is safe for dialysis patients, that a single antiplatelet regimen postprocedure is safe, and that LAAO effectively reduces the composite endpoint of stroke\u002Ftransient ischemic attack and major bleeding compared to standard care. Instruments: The study employs a multicenter, single-arm prospective registry design. Eligible participants, aged ≥18 with documented AF and ESRF on peritoneal dialysis (PD) or hemodialysis (HD), will undergo LAAO using the Watchman Flx PRO device. Propensity score matched historical cohort from dialysis registry will be identified for comparison.\n\nMain Outcome Measures: The primary endpoint is the composite of stroke\u002Ftransient ischemic attack\u002Fsystemic embolism and non-procedural-related major bleeding at one year. Secondary endpoints include individual rates of these events, procedural safety and device occlusion effectiveness. Data Analysis and Expected Results: Statistical analysis will involve descriptive statistics, chi-squared tests, and propensity score matching. A p-value of \\\u003C0.05 will be deemed significant. The pilot study anticipates a low peri-procedural complication rate (≤5%) and confirms LAAO's efficacy in stroke and major bleeding reduction in Chinese PD and HD patients compared to standard care. This data will inform the design of a larger randomized controlled trial aimed at validating LAAO as a safe alternative for AF management in dialysis populations.",[133,134,135,136,137,63],"Dialysis","Chronic Kidney Disease (Stages 3b-5)","Atrial Fibrillation","End Stage Kidney Failure","Stroke Prevention in Patients With Atrial Fibrillation","2025-12-02",{"date":140,"type":37},"2025-12-04",{"date":117,"type":21},{"date":143,"type":21},"2028-07-05",{"name":43,"class":44},{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":152,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":45},"100597283","phase-3-rankl-inhibition-to-combat-sarcopenia-in-hip-fracture-patients-100597283","NCT07056478","RANKL Inhibition to Combat Sarcopenia in Hip Fracture Patients","RANKL Inhibition to Combat Sarcopenia in Hip Fracture Patients: A Pragmatic, Randomized Double-blind, Active-Controlled Trial","Inclusion Criteria:\n\n* Elderly aged 65 years or older\n* Diagnosed with sarcopenia following AWGS guidelines - low appendicular skeletal muscle mass measured by dual-energy x-ray absorptiometry (Cutoff: Male \\\u003C7.0kg\u002Fm2, and female \\\u003C5.4kg\u002Fm2) AND low handgrip strength (Cutoff: Male \\\u003C 28kg, Female \\\u003C18 kg) OR low physical performance (6-metre walk, cutoff: \\\u003C1.0m\u002Fs or 5-time chair stand test \\>=12s)\n* Diagnosed with a hip fracture from low-energy mechanism (e.g., falling from standing height) requiring an operation\n* Willing and able to comply with study protocol including follow-up evaluations.\n\nExclusion Criteria:\n\n* open fracture\n* multiple fractures\n* pathological fractures e.g., tumour, infection, etc.\n* history of medication or disease affecting bone metabolism e.g., hypo\u002Fhyperthyroidism\n* malignancy\n* chairbound or bedbound (unable to perform assessments)\n* serious cognitive problems e.g., severe dementia (unable to agree for consent) - renal impairment with glomerular filtration rate \\\u003C30 mL\u002Fmin\n* prior anti-osteoporotic medication e.g. bisphosphonates, denosumab, etc.\n* active infection,\n* severe malnutrition i.e. Mini Nutritional Assessment \\\u003C 17 points\n* serious neurological or neuromuscular conditions e.g. Parkinson's disease\n* uncontrolled chronic conditions e.g. poorly controlled diabetes mellitis\n* not anaesthetically fit for operation or conservative management","65 Years",{"count":154,"type":21},130,[156],"PHASE3","The objective of this study is to conduct a pragmatic, randomized, double-blind, active-controlled trial to assess the efficacy of receptor activator of nuclear factor-kB ligand (RANKL) inhibition in the treatment of sarcopenia in hip fractures.",[159],"Sarcopenia in Elderly","2025-06-29",{"date":162,"type":37},"2025-07-09",{"date":164,"type":21},"2026-01-01",{"date":166,"type":21},"2030-01-01",{"name":43,"class":44},{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":45},"100596200","application-of-comprehensive-non-invasive-assessment-to-phenotype-tricuspid-regurgitation-100596200","NCT07042360","Application of Comprehensive Non-invasive Assessment To Phenotype Tricuspid Regurgitation","TRIREF","Inclusion Criteria:\n\n* Patients with \\>=moderate TR\n* able to consent for the study.\n\nExclusion Criteria:\n\n1. LVEF \\\u003C=40%\n2. Have significant left sided organic valvular heart disease (i.e. \\>=moderate AS, \\>=moderate MS, \\>=moderate MR of organic or mixed aetiology), dysfunctional mitral valve replacement or aortic valve replacement\n3. Prior tricuspid valve interventions (eg TriClip, tricuspid valve repair or replacement) (To allow accurate transient elastography)\n4. Known hepatocellular carcinoma\n5. Known portal vein thrombosis\n6. Established liver cirrhosis with a known liver-related aetiology\n7. Hepatitis C infection and not on treatment\n8. Uncontrolled hepatitis (e.g. hepatitis B infection, autoimmune hepatitis)\n9. Fatty liver with evidence of non-alcoholic fatty liver disease or cirrhosis (to allow accurate non-invasive lung fluid assessment)\n10. recent rib fracture (\\\u003C3 months) with or without flail chest\n11. BMI \\\u003C20 or \\>36\n12. Height \\\u003C155cm or \\>195cm\n13. Patients with right lung tumor\n14. Patients with right sided pacemaker\n15. Patients with known underlying exudative right pleural effusion",{"count":176,"type":21},450,"Tricuspid regurgitation (TR) is an increasingly recognized valvular heart disease associated with high morbidity and mortality. With the availability of various novel transcatheter tricuspid interventions, it is no longer considered a \"forgotten valve.\" Heart failure with preserved ejection fraction (HFpEF) is a prevalent condition also characterized by high morbidity and mortality. The prevalence of moderate to severe TR in the general population is 3% to 6%; however, in patients with heart failure (with reduced or preserved ejection fraction \\[EF\\]), the prevalence is 10% to 29%, rising to up to 39% in patients with HFpEF and atrial fibrillation (AF). The EuroTR registry, an international registry including patients who underwent percutaneous treatment for severe TR, reported that 72% of patients had a left ventricular ejection fraction (LVEF) ≥50%. In a subgroup of patients with right heart catheterization data, 68% had a pulmonary capillary wedge pressure (PCWP) ≥15 mm Hg, indicating that many of these patients may have HFpEF. Patients with significant TR have also been shown to experience irreversible liver derangement and cirrhosis. Non-invasive evaluation of liver stiffness (LS), measured by transient elastography, has recently received increased attention in patients with heart failure and has been shown to closely correlate with right-sided filling pressures. LS has been used to predict adverse outcomes in patients undergoing transcatheter aortic valve (TA) surgery with concomitant left-sided valve surgery.\n\nOn the other hand, the Remote Dielectric Sensing System (ReDS; Sensible Medical Innovations, Israel) is a device that measures lung fluid non-invasively and provides an objective and reproducible index of volume status. It is an FDAapproved device for heart failure patients. ReDS measurements are presented as the percentage of fluid relative to lung volume, with normal values ranging between 20% to 35%. Studies have demonstrated excellent correlations between the ReDS index and computed tomography (CT)-measured lung water and invasively determined hemodynamics. Additionally, it has been shown to predict heart failure rehospitalization in patients with acute heart failure.\n\nGiven the emergence of novel transcatheter tricuspid interventions and the established link between TR, HFpEF, and markers such as liver stiffness and lung fluid index (measured by ReDS), this study will examine the intricate interplay between these conditions and their shared pathophysiology. By analyzing left and right heart function, risk factors, and treatment outcomes, the research aims to phenotype TR using non-invasive assessment tools to predict clinical outcomes and improve treatment strategies for patients with different types of TR. Our findings will contribute to developing more effective and personalized treatment plans for patients with TR.",[31],"2025-06-19",{"date":160,"type":37},{"date":182,"type":37},"2025-04-01",{"date":184,"type":21},"2029-03-31",{"name":43,"class":44},{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":194,"targetDuration":130,"studyType":83,"phases":4,"briefSummary":196,"conditions":197,"keywords":199,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":205,"leadSponsor":207,"locationsCount":45},"100594604","a-clinical-and-imaging-registry-of-transcatheter-aortic-valve-implantation-using-jenavalve-system-j-valve-system-for-patients-with-pure-aortic-regurgitation-100594604","NCT07021612","A Clinical and Imaging Registry of Transcatheter Aortic Valve Implantation Using JenaValve System\u002F J-Valve System for Patients With Pure Aortic Regurgitation","A Clinical and Imaging Registry of Transcatheter Aortic Valve Implantation Using JenaValve System\u002F J-Valve System for Patients With Pure Aortic Regurgitation: An Observational Study","CAIR-JAR","Inclusion Criteria:\n\n1. receiving transcatheter aortic valve implantation (TAVI) (using Jenavalve\u002FJ-Valve) in PWH\n2. with severe symptomatic AR (NYHA III-IV) despite optimal medical therapy\n3. Deemed high risk for aortic valve surgery determined by a multidisciplinary heart team (including cardiologists, cardiac surgeons and cardiac anesthetists)\n4. Capable of providing informed consent\n\nExclusion Criteria:\n\n1. Evidence of intracardiac mass, thrombus or vegetation\n2. Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT\n3. Sepsis or active endocarditis within 3 months, or infections requiring antibiotic therapy within 2 weeks prior to the planned procedure\n4. Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint.\n5. Chronic Kidney Disease with eGFR \\\u003C30 ml\u002Fmin\u002F1.73m2.\n6. Cardiogenic shock or other hemodynamic instability requiring inotropic support or ventricular assist device\n7. Contraindicated for CT or MRI assessment",{"count":195,"type":21},30,"Aortic regurgitation (AR) is not uncommon. Transcatheter aortic valve implantation (TAVI) for treating pure aortic regurgitation is a potential future treatment option for pure AR especially in patients having high risk for open heart surgery.\n\nTAVI using dedicated device for pure AR has a different anchor mechanism to TAVI for aortic stenosis (AS). AR patientsalso have different cardiac flow pattern, aortic root pathology and left ventricular remodeling pattern compared to AS patients. Subclinical leaflet thrombosis has been described in AS patient receiving TAVI, which will affect the durability and antithrombotic regime. Follow-up imaging for dedicated TAVI device in AR patient is limited.",[198],"Aortic Valve Disease",[200],"Transcatherter Aortic Valve Intervention","2025-06-13",{"date":203,"type":37},"2025-06-15",{"date":182,"type":37},{"date":206,"type":21},"2028-09-30",{"name":43,"class":44},{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":218,"briefSummary":219,"conditions":220,"keywords":222,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":227,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":45},"100594603","artificial-intelligence-versus-sonographer-echocardiogram-analysis-and-reporting-in-patients-with-heart-failure-100594603","NCT07021599","Artificial Intelligence Versus Sonographer Echocardiogram Analysis and Reporting in Patients With Heart Failure","Artificial Intelligence Versus Sonographer Echocardiogram Analysis and Reporting in Patients With Heart Failure: A Randomized Controlled Trial","AISEARHF","Inclusion Criteria:\n\n* Aged 18 years or above\n* Has new or worsening of heart failure symptoms\n* Elevated heart failure blood markers (N-terminal prohormone of brain natriuretic peptide, \"NTproBNP\") within 3 months from enrolment or by point-of-care blood test, to ensure that the patient's symptoms are cardiac origin\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Known severe valvular heart disease\n* Prior prosthetic valve implantation\n* Previously known or suspected \\>=severe tricuspid regurgitation, \\>=moderate aortic regurgitation, \\>=moderate mitral stenosis or pericardial disease during detected during image acquisition\n* Insufficient image quality for proper analysis determined by the scanning sonographer (estimated to be 15% of all echocardiograms screened)",{"count":217,"type":21},514,[24],"This is a non-inferiority, three-year, multicenter, double-blinded randomized controlled study of an AI versus experienced sonographer echocardiogram analysis in HF patients. Consecutive patients presented for echocardiogram examination with new or worsening HF symptom and positive HF blood markers will be recruited. A target of 514 patients will be randomized 1:1 to receive either AI or sonographer echocardiogram analysis. The primary endpoint of diagnostic accuracy is the complete agreement of disease grading with an experienced cardiologist (American Society of Echocardiography level III) using a standardized grading chart. Important secondary endpoints include the time used for echocardiogram report drafting and report endorsement, 6-month heart failure symptom and hospitalization, and the cost-effectiveness of AI to increase echocardiogram service. Clinical, biochemical and echocardiographic predictors of worsening of heart failure and hospitalization will be identified.",[221],"Heart Failure",[223,224,225,226],"Echocardiogram","Artificial Intelligence","Alogrithm","Echocardiological image analysis",{"date":203,"type":37},{"date":229,"type":21},"2025-07-01",{"date":231,"type":21},"2028-12-03",{"name":43,"class":44},{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":239,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":22,"phases":242,"briefSummary":243,"conditions":244,"keywords":247,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":45},"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":20,"type":21},[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.",[245,246],"Mitral Annulus Calcification","Rheumatic Heart Disease",[248],"Mitral valve stenosis","2025-04-23",{"date":251,"type":37},"2025-04-30",{"date":253,"type":37},"2025-03-08",{"date":255,"type":21},"2027-03-31",{"name":43,"class":44},{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":16,"minAge":152,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":22,"phases":266,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":45},"100565561","phase-4-rank-ligand-inhibition-to-combat-sarcopenia-with-underlying-osteoporosis-100565561","NCT06643780","RANK-ligand Inhibition to Combat Sarcopenia with Underlying Osteoporosis","RANK-ligand Inhibition to Combat Sarcopenia with Underlying Osteoporosis: a Randomized, Double-blind, Double-dummy, Active-Controlled Trial","Inclusion Criteria:\n\n* Elderly males or females aged 65 years or older\n* diagnosed with osteosarcopenia (sarcopenia diagnosis based on AWGS 2019 guidelines - low appendicular skeletal muscle mass (ASM) by Dual-energy X-ray absorptiometry (DXA) (M:\\<7.0kg\u002Fm2, F:\\<5.4kg\u002Fm2) AND low handgrip strength (M:\\<28kg, F:\\<18kg) OR low physical performance (6-metre walk: \\<1.0m\u002Fs or 5-time chair stand test ≥ 12 s); osteoporosis diagnosed based on World Health Organization (WHO) criteria with DXA scan T-score ≤ -2.5)\n* Willing and able to comply with study protocol including follow-up evaluations.\n\nExclusion Criteria:\n\n* history of recent fracture i.e., within 3 months\n* history of prior anti-osteoporotic drug\n* disease or medication affecting bone or muscle metabolism\n* Chairbound or bedbound\n* Unable to agree for consent\n* contraindication to drug i.e., Denosumab or Zoledronic Acid\n* Underlying malignancy or disease known to cause cachexia\n* severe renal impairment e.g., Creatinine Clearance (CrCl) \\< 35ml\u002Fmin\n* moderate to severe liver failure (Child-Pugh Class B or C).",{"count":265,"type":21},120,[267],"PHASE4","The objective of this study was to conduct a randomized, double-blind, double-dummy active controlled trial to determine the efficacy of denosumab in treating sarcopenia with underlying osteoporosis.",[159],"2024-10-13",{"date":272,"type":37},"2024-10-16",{"date":274,"type":37},"2024-04-09",{"date":276,"type":21},"2027-10",{"name":43,"class":44},""]