[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mitral-insufficiency\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mitral-insufficiency":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,40,68,92,110,143,171,193,218],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100621426","transcatheter-mitral-and-tricuspid-interventions-a-cardiac-magnetic-resonance-study-100621426",false,"NCT07370467","Transcatheter Mitral and Tricuspid Interventions: a Cardiac Magnetic Resonance Study","TEMATIC-MR: Transcatheter Mitral and Tricuspid Interventions: a Cardiac Magnetic Resonance Study","TEMATIC-MR","Inclusion Criteria:\n\n* Age ≥ 18 anni\n* Signing informed consent\n* Patients who are candidates for transcatheter mitral or tricuspid surgery (TEER, TTVR).\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Contraindications to CMR or administration of contrast medium (gadolinium)","ALL","18 Years",{"count":20,"type":21},250,"ESTIMATED","OBSERVATIONAL","Mitral and tricuspid valve disease represents an increasing challenge in the management of patients with heart failure and other cardiovascular diseases. In recent years, the introduction of transcatheter techniques for valve repair and replacement (TVI) has revolutionised the treatment of these diseases, particularly for patients at high surgical risk or who are not candidates for traditional surgery. However, although these procedures are increasingly popular, their long-term effectiveness in terms of cardiac remodelling is still not well understood.\n\nCardiac magnetic resonance (CMR) techniques, with their advanced capabilities to provide anatomical and functional details of the heart, offer a unique opportunity to assess ventricular remodelling and valve function before and after transcatheter interventions. The ESC guidelines on valvulopathies published in 2021 recommend the use of cardiac magnetic resonance imaging not only to quantify the extent of mitral and tricuspid regurgitation when echocardiography is inconclusive, but also as the gold standard for the assessment of left and right ventricular size and function (limited, however, to the availability of this method in the various centres). Currently, there are few systematic data evaluating the effect of these procedures on CMR-assessed cardiac anatomy and function. This study aims to fill this gap by creating a multicentre registry in which clinical and advanced imaging data, including 3D echocardiography and CMR, are collected to assess the impact of these therapies.\n\nAnalysis of data derived from advanced imaging will not only provide a better understanding of the mechanism of operation of transcatheter techniques, but will also provide important information for improving long-term patient outcomes by identifying potential predictors of treatment success or failure.",[25,26],"Mitral Insufficiency","Transcatheter Aortic Valve Replacement","RECRUITING","2026-06-08",{"date":30,"type":31},"2026-06-09","ACTUAL",{"date":33,"type":31},"2026-01-30",{"date":35,"type":21},"2026-09-30",{"name":37,"class":38},"Centro Cardiologico Monzino","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":39},"100583481","mitral-regurgitation-risk-assessment-and-clinical-modelling-100583481","NCT06876883","MItral Regurgitation Risk Assessment and CLinical modElling","MItral Regurgitation Risk Assessment and CLinical modElling (MIRACLE Study)","MIRACLE","Inclusion Criteria:\n\n* Patients diagnosed with ≥ moderate mitral regurgitation during hospitalization.\n* Aged over 18 yrs.\n\nExclusion Criteria:\n\n* Patients unable to provide written consent.",{"count":49,"type":21},2000,"Mitral regurgitation (MR) is a common valvular heart disease worldwide, and untreated severe MR is associated with an elevated risk of heart failure and mortality. According to causes, MR could be divided into primary or secondary MR. The risk factors of mortality or heart failure hospitalization in different types of MR patients are under intensive investigation.\n\nMItral Regurgitation risk Assessment and CLinical modElling (MIRACLE) study is a prospective cohort study including adult patients diagnosed with ≥ moderate MR during hospitalization. Comprehensive echocardiographic examination was conducted at baseline evaluating valvular heart disease severity, atrial and ventricular systolic\u002Fdiastolic function, pulmonary artery systolic pressure (PASP), etc. We aim to evaluate the prognostic risk factors of patients with MR and construct a prognostic clinical model to guide clinical decision-making.",[25,52],"Mitral Regurgitation (MR)",[54,55,56,57,58],"mitral regurgitation","all-cause mortality","clinical modelling","cardiovascular mortality","heart failure hospitalization","2025-08-28",{"date":61,"type":31},"2025-09-05",{"date":63,"type":31},"2016-06-15",{"date":65,"type":21},"2030-06-15",{"name":67,"class":38},"Sun Yat-sen University",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":91},"100395513","miclasp-post-market-clinical-follow-up-pmcf-study-100395513","NCT04430075","MiCLASP Post Market Clinical Follow-Up (PMCF) Study","Transcatheter Repair of Mitral Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post Market Clinical Follow-Up (PMCF)","MiCLASP","Inclusion Criteria:\n\n1. Mitral TEER patients eligible per the current approved indication after Heart Team discussion and agreement\n2. Patient is willing and able to attend all follow-up visits and to perform all tests\n3. Provision of written informed consent\n\nExclusion Criteria:\n\n1. Patients are not eligible per the current Instructions for Use\n2. Non-elective or emergency TEER procedure for mitral regurgitation\n3. Patients in ICU prior to the index procedure",{"count":77,"type":21},1000,"This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter mitral valve repair.",[80,25],"Mitral Regurgitation","2025-06-25",{"date":83,"type":31},"2025-06-26",{"date":85,"type":31},"2019-08-23",{"date":87,"type":21},"2031-03-31",{"name":89,"class":90},"Edwards Lifesciences","INDUSTRY",37,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":39},"100594476","afterload-mismatch-predictive-modle-for-transcatheter-edge-to-edge-repair-ample-teer-100594476","NCT07019935","Afterload Mismatch Predictive modLE for Transcatheter Edge-to-Edge Repair (AMPLE-TEER)","Afterload Mismatch Predictive modLE for Transcatheter Edge-to-Edge Repair (AMPLE-TEER Study)","Inclusion Criteria:\n\n* Patients undergoing transcatheter mitral valve edge-to-edge repair (TEER) during hospitalization.\n* Aged over 18 yrs.\n\nExclusion Criteria:\n\n* Patients unable to provide written consent.",{"count":77,"type":21},"Mitral regurgitation (MR) is one of the most common valvular heart diseases in China, causing heart failure. Patients with moderate to severe MR have a very poor clinical prognosis if no intervention is performed. When symptoms are still poorly controlled after guideline-directed medical therapy (GDMT) or when surgical intervention is not suitable, transcatheter mitral valve edge-to-edge repair (TEER) can improve the patient's quality of life and reduce the hospitalization rate and mortality rate. However, some patients develop into afterload mismatch (AM) after TEER, persistent adverse ventricular remodeling, and a high mortality rate, which limits the surgical benefits of TEER surgery in these MR patients. Therefore, how to scientifically predict AM and intervene as early as possible has become a research hotspot for optimizing the postoperative management of TEER patients. Afterload Mismatch Predictive modLE for Transcatheter Edge-to-Edge Repair (AMPLE-TEER) study is a prospective cohort study including adult patients undergoing TEER during hospitalization. We aim to evaluate whether the patients develop into AM after TEER, evaluate the prognostic risk factors of AM and construct a prognostic clinical model to guide clinical decision-making.",[25],"2025-06-05",{"date":104,"type":31},"2025-06-13",{"date":106,"type":31},"2021-10-01",{"date":108,"type":21},"2030-10-01",{"name":67,"class":38},{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":126,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":142},"100551873","altavalve-pivotal-trial-100551873","NCT06465745","AltaValve Pivotal Trial","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Symptomatic New York Heart Association (NYHA) class II-IV.\n* Moderate-to-severe or severe MR (3+) despite optimal guideline-directed medical therapy (GDMT) as determined by an independent Echo Core Lab.\n* Unsuitable for surgery and Transcatheter Edge-toEdge Repair (TEER) as determined by the local site Heart Team.\n\nExclusion Criteria (Abbreviated List):\n\n* Inability to understand the trial or a history of non-compliance with medical advice.\n* Inability to provide signed Informed Consent Form (ICF).\n* History of any cognitive or mental health status that would interfere with participation in the trial.\n* Currently enrolled in any other pre-approval investigational trial (does not apply to long-term post-market trials unless these trials might clinically interfere with the current trial endpoints (e.g., limit use of trial-required medication, etc.)).\n* Female subjects who are pregnant or planning to become pregnant within the trial period.\n* Known hypersensitivity or contraindication to heparin, or warfarin without adequate alternative medications.\n* Known hypersensitivity to nitinol (i.e., nickel allergy) that cannot be adequately medicated.\n* Known hypersensitivity to contrast media that cannot be adequately medicated.\n* Evidence of current left ventricular ejection fraction (LVEF) ≤ 25%.\n* Concurrent medical condition with a life expectancy of less than 12 months.\n* Transcatheter aortic repair or replacement within 90 days prior to the index procedure.\n* Percutaneous coronary intervention (PCI) within 90 days prior to the index procedure.",{"count":117,"type":21},450,"INTERVENTIONAL",[120],"NA","This is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population.",[80,25,123,124,125],"Mitral Valve Incompetence","Mitral Valve Regurgitation","Mitral Incompetence",[80,127,128,129,130,131,132],"TMVR","Functional Regurgitation","Degenerative Regurgitation","Transcatheter Mitral Valve Replacement","Primary Regurgitation","Secondary Regurgitation","2025-04-30",{"date":135,"type":31},"2025-05-02",{"date":137,"type":31},"2024-09-03",{"date":139,"type":21},"2031-09",{"name":141,"class":90},"4C Medical Technologies, Inc.",29,{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":170},"100586109","assessment-of-transcatheter-edge-to-edge-repair-in-atrial-functional-mitral-regurgitation-atrial-mr-100586109","NCT06911099","Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation (ATRIAL-MR)","Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation","Inclusion Criteria:\n\n* functional mitral regurgitation\n* left ventricular ejection fraction ≥50%\n\nExclusion Criteria:\n\n* age under 18 years\n* known regional wall movement disorders",{"count":77,"type":21},"This investigator-initiated, multicenter, international, retrospective registry aims to investigate outcomes of patients with atrial functional mitral regurgitation, as treated in clinical routine.",[153,25],"Atrial Functional Mitral Regurgitation",[155,156,157,158,159,160],"atrial functional mitral regurgitation","AFMR","atrial secondary mitral regurgitation","ASMR","mitral valve transcatheter edge-to-edge repair","M-TEER","2025-04-03",{"date":163,"type":31},"2025-04-06",{"date":165,"type":31},"2010-01-01",{"date":167,"type":21},"2035-12-31",{"name":169,"class":38},"University Hospital of Cologne",22,{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":177,"enrollmentInfo":178,"targetDuration":4,"studyType":118,"phases":180,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":184,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":189,"leadSponsor":191,"locationsCount":39},"100578466","outcomes-of-complete-versus-partial-preservation-of-the-sub-valvular-apparatus-in-cases-of-mitral-valve-replacement-100578466","NCT06811662","Outcomes of Complete Versus Partial Preservation of the Sub-valvular Apparatus in Cases of Mitral Valve Replacement","Inclusion Criteria:\n\n* \\- Age between 18 and 60 years\n* Rheumatic mitral disease indicated for mitral valve replacement\n* Concomitant other valve disease\n\nExclusion Criteria:\n\n* \\- Patients who have undergone previous mitral valve surgery or other heart surgery.\n* Patients with ischemic mitral disease.\n* emergency operation.\n* patients with significant comorbidities (severe pulmonary disease or end stage renal disease).","60 Years",{"count":179,"type":21},80,[120],"The purpose of this study is to evaluate the outcomes of complete (preservation of both anterior and posterior leaflets) versus partial (preservation of posterior leaflet only) preservation of subvalvular apparatus in cases of mitral valve replacement",[183,25],"Mitral Valve Replacement","NOT_YET_RECRUITING","2025-02-01",{"date":187,"type":31},"2025-02-06",{"date":185,"type":21},{"date":190,"type":21},"2027-12",{"name":192,"class":38},"Assiut University",{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":200,"minAge":18,"maxAge":4,"enrollmentInfo":201,"targetDuration":203,"studyType":22,"phases":4,"briefSummary":204,"conditions":205,"keywords":206,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":39},"100572849","assessing-the-relationship-between-symptoms-and-mitral-regurgitnant-severity-100572849","NCT06738615","Assessing the Relationship Between Symptoms and Mitral Regurgitnant. Severity","Assessing the Impact of Diastolic Dysfunction on the Presence of Symptoms in Patients with Primary Mitral Regurgitation.","Inclusion Criteria:\n\n* Age \\>=18 years of age\n* Able to give informed consent\n* Primary (degenerative) mitral regurgitation\n* LVEF \\>=50%\n* Undergoing cardiac catheterization\n* Able to exercise on a treadmill\n\nExclusion Criteria:\n\n* Unable to give informed consent\n* Secondary (functional) mitral regurgitation\n* LVEF \\\u003C50%\n* Known coronary artery stenosis \\>=70% or past revascularization\n* More than mild aortic stenosis, mitral stenosis, aortic regurgitation, tricuspid regurgitation, or pulmonic regurgitation\n* Hypertrophic cardiomyopathy\n* Pregnancy","MALE",{"count":202,"type":21},40,"1 Year","The current American College of Cardiology\u002FAmerican Heart Association (ACC\u002FAHA) guidelines recommend surgery in patient with mitral regurgitation (MR) based on 1) the severity of MR and 2) the presence or absence of symptoms. Studies have shown that Cardiovascular Magnetic Resonance (CMR) is an accurate method to quantify the severity of MR. However, studies have also shown that symptoms are not necessarily related to the presence of symptoms. Thus, there appears to be a disconnect between the severity of MR and symptoms. Recent analysis of our data has shown that females and older patients with smaller ventricles, lower stroke volumes, and lower regurgitant volume relative to regurgitant fraction tend to be symptomatic. These findings suggest that decreased left ventricular compliance, i.e. diastolic dysfunction, may play an important role as an etiology of symptoms in patients with mitral regurgitation. The aim of this study is to study the presence of diastolic dysfunction in patients with MR and its association with symptom burden and exercise capacity.",[25],[54,207,208],"symptoms","exercise capacity","2024-12-13",{"date":211,"type":31},"2024-12-17",{"date":213,"type":21},"2025-01-02",{"date":215,"type":21},"2027-05-02",{"name":217,"class":38},"Atlantic Health System",{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":118,"phases":227,"briefSummary":228,"conditions":229,"keywords":237,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":39},"100545096","influence-of-lung-ultrasonography-on-the-prognosis-and-postoperative-outcomes-in-cardiac-surgical-patients-100545096","NCT06377449","Influence of Lung Ultrasonography on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients","Influence of Ultrasound Examination of the Lungs on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients","Inclusion Criteria:\n\n* open heart surgery with cardiopulmonary bypass (CPB) between 15 December 2023 and 15 December 2024\n* signed informed consent for participation in the study\n\nExclusion Criteria:\n\n* reoperations on the open heart with CPB\n* surgical procedures on lungs and lung cancer in the anamnesis\n* chronic obstructive pulmonary disease, stage III\n* chronic kidney disease, stages 4 and 5\n* patients with low Risk Score profile by the Society of Thoracic Surgeons",{"count":226,"type":21},186,[120],"The goal of this interventional is to assess advantages of the ultrasound examination of the lungs in the early postoperative period in cardiac surgical patients after heart surgeries requiring cardiopulmonary bypass. Evaluation of pulmonary complications and outcomes during mid-term follow-up, as well as comparison of ultrasound examination and traditional roentgenologic methods (X-ray examination and CT of the chest) will be performed. The main question\\[s\\] it aims to answer are:\n\n* Is ultrasound examination of the lungs a more specific and sensitive method in identification of early postoperative pulmonary complications after on-pump cardiac surgical procedures, in comparison with traditional X-ray methods.\n* Does early identification of interstitial pulmonary edema (based on number of visualised B-lines in the early postoperative period), influences mid-term outcomes in this cohort of patients Participants will undergo ultrasound examination of the lungs on postoperative day 1, 3, 5 and 7 after heart surgery. Based on ultrasound findings and degree of interstitial pulmonary edema, medical (diuretics, anti-inflammatory, e.t.c) therapy will be modified.\n\nResearchers will compare this group of patients with control group, in which ultrasound examination will be performed in the same time frames, but no changes in medical management based on ultrasound findings will be made to see if timely administered medical therapy, based on ultrasound findings, can significantly improve symptoms, hospital lengths of stay and outcomes of this patients.",[230,231,232,233,25,234,235,236],"Ischemic Heart Disease","Aortic Stenosis, Severe","Aortic Insufficiency","Mitral Stenosis","Mitral Stenosis With Insufficiency","Tricuspid Insufficiency","Ascending Aortic Aneurysm",[238,239,240,241,242,243],"Ultrasound examination of the lungs","B-lines","Coronary artery bypass grafting","Heart valve surgery","Cardiopulmonary bypass","On-pump cardiac surgery","2024-12-04",{"date":246,"type":31},"2024-12-09",{"date":248,"type":31},"2024-05-15",{"date":250,"type":21},"2026-01-01",{"name":252,"class":38},"Saint Petersburg State University, Russia"]