[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mitral-valve-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mitral-valve-disease":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,47,75,98,119,144,169,194,230,259,281,307,334,361,381,413,434,460,479,497],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":20,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100598298","abbott-cephea-mitral-valve-disease-registry-100598298",false,"NCT07069673","Abbott Cephea Mitral Valve Disease Registry","Inclusion Criteria:\n\n1. Symptomatic mitral valve disease resulting in mitral regurgitation and\u002For severe mitral valve stenosis.\n2. New York Heart Association (NYHA) Functional Class II, III, or ambulatory IV.\n3. In the judgement of the Site Heart Team, transcatheter therapy is deemed to be more appropriate than conventional mitral valve surgery, TMVR is more likely to provide an optimal result than TEER, and the subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, and heart failure.\n4. Age 18 years or older at time of consent.\n5. The subject agrees to the study requirements, permits all follow-up data entry, and has provided written informed consent.\n\nExclusion Criteria:\n\n1. Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.\n2. Subject is undergoing dialysis or experiencing chronic renal failure\n3. Subject has chronic lung disease requiring continuous home oxygen therapy or chronic outpatient oral steroid use\n4. Subjects with comorbidities that are likely to result in a life expectancy of less than 12 months.\n5. Pregnant or nursing subjects and those who plan pregnancy during the follow-up period.","ALL","18 Years",{"count":18,"type":19},1000,"ESTIMATED","2 Years","OBSERVATIONAL","The objective of this registry is to gather clinical data on symptomatic patients with mitral valve disease, including patients with mitral regurgitation, mitral stenosis, and mixed mitral valve disease. Data collected from this registry are expected to improve our understanding of the impact of correcting symptomatic mitral valve disease on clinical outcomes in patients that could be candidates for Transcatheter Mitral Valve Replacement and may also inform future regulatory or reimbursement submission strategies for the Cephea Mitral Valve System.",[24,25,26,27,28,29,30],"Mitral Regurgitation","Mitral Stenosis","Mitral Valve Disease","Mitral Valve (MV) Regurgitation","Mitral Annulus Calcification","Mitral Valve Replacement","Transcatheter Valve Replacement",[26,32,33],"registry","Cephea Mitral Valve System","RECRUITING","2026-06-18",{"date":37,"type":38},"2026-06-22","ACTUAL",{"date":40,"type":38},"2025-08-13",{"date":42,"type":19},"2028-12",{"name":44,"class":45},"Abbott Medical Devices","INDUSTRY",23,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":55,"targetDuration":20,"studyType":21,"phases":4,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100280084","management-and-clinical-outcomes-of-patients-with-severe-mitral-valve-disease-not-suitable-for-surgery-100280084","NCT02925819","Management and Clinical Outcomes of Patients With Severe Mitral Valve Disease Not Suitable for Surgery","Management And Clinical Outcomes Of Patients With Severe Mitral Disease Not Suitable For Surgery: A Prospective, Multicentric, Observational Study","MITRAGISTER","* Aged over 18 years\n* Presenting with severe mitral valve stenosis or regurgitation regardless of etiology (primary mitral regurgitation, secondary mitral regurgitation, deterioration of mitral valve repair or bioprosthesis, mitral annular calcification)\n* Symptomatic (NYHA functional class II-IV) despite optimized medical therapy\n* Judged not eligible for surgical treatment according to a specialized multidisciplinary meeting called \"heart team\" comprising at least one cardiothoracic surgeon, one interventional cardiologist, one echocardiographer, one clinical cardiologist and one anaesthesiologist.\n* Having received information about the study and not expressing opposition to the use of their data\n* Patient not included in a clinical trial\n\nExclusion Criteria:\n\n* Asymptomatic patients\n* Absence of severe mitral regurgitation or stenosis\n* Patient judged eligible for surgical treatment according to a specialized multidisciplinary meeting called \"heart team\" comprising at least one cardiothoracic surgeon, one interventional cardiologist, one echocardiographer, one clinical cardiologist and one anaesthesiologist.\n* Pregnant or breastfeeding women\n* Having not received information about the study or having expressed opposition to the use of their data",{"count":56,"type":19},500,"The objective of this study is to collect in a prospective registry all cases of French patients undergoing an assessment for percutaneous treatment of mitral valve disease on a native valve or due to deterioration after surgical valve repair or replacement. In these patients, valvular surgery should be considered contra-indicated or at prohibitive risk. This registry will evaluate the morbidity and mortality up to 24 months for those patients with severe mitral valve disease who are not included in a clinical trial. The association of demographic, clinical, laboratory, echocardiographic variables and treatment options with morbidity and mortality will be evaluated by univariate and multivariate analyses.",[26],[60,61,62,63],"Mitral regurgitation","Mitral stenosis","Mitral valve repair deterioration","Bioprosthesis degeneration","2026-06-11",{"date":66,"type":38},"2026-06-12",{"date":68,"type":38},"2016-10",{"date":70,"type":19},"2026-12",{"name":72,"class":73},"French Cardiology Society","OTHER",3,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100639190","mitral-valve-calcium-assessment-with-truevue-trans-illumination-3d-rendering-100639190","NCT07612553","MitrAl Valve Calcium aSsEssmEnt With TrueVue Trans-illumination 3D Rendering.","MitrAl Valve Calcium aSsEssmEnt With TrueVue Trans-illumination 3D Rendering (MAC SEE).","MAC-SEE","Inclusion Criteria\n\nRetrospective Cohort\n\n* Have already undergone, between February 2025 and September 2025, a contrast-enhanced CT scan and a transesophageal echocardiogram.\n* Are ≥ 18 years old.\n\nProspective Cohort\n\n* Are scheduled to undergo a contrast-enhanced CT scan and a three-dimensional transesophageal echocardiogram as part of their routine clinical assessment for their underlying cardiac condition, with or without mitral annular or leaflet calcifications.\n* Are ≥ 18 years old\n* who have provided written informed consent to participate in the study\n\nExclusion Criteria:\n\nRetrospective Cohort\n\n* The following patients will be considered not eligible:\n* Patients younger than 18 years.\n* Patients whose data are incomplete for the purposes of the planned study assessments\n* Patients who have explicitly refused the use of their data for research purposes.\n\nProspective Cohort\n\n* Patients younger than 18 years.\n* Patients who have not signed the study Informed Consent Form",{"count":84,"type":19},100,"The study of calcifications involving the mitral valve is extremely important for the planning of both surgical and percutaneous procedures. Computed tomography (CT) is the non-invasive imaging modality considered the gold standard for the assessment of mitral valve calcifications, thanks to its high spatial resolution and the strong X-ray attenuation of calcium deposits.\n\nEchocardiography has traditionally played a limited role in the evaluation of mitral valve calcifications, particularly with three-dimensional imaging. Three-dimensional transesophageal echocardiographic rendering with TrueVue transillumination (Philips Medical Systems, Eindhoven, NL) can provide additional information on the location and extent of calcium on the mitral valve by allowing the placement of a virtual light source beneath the mitral valve.\n\nSpecifically, the TrueVue system is an advanced software module integrated into Philips echographic equipment that uses data acquired by the transesophageal probe to generate photorealistic images of the heart.\n\nTherefore, the ability to evaluate the position and extent of calcifications through transesophageal echocardiography may represent an important step forward for echocardiographic imaging.",[87,26],"Mitral Annular Calcification","2026-05-21",{"date":90,"type":38},"2026-05-28",{"date":92,"type":38},"2025-12-17",{"date":94,"type":19},"2026-06-01",{"name":96,"class":73},"Centro Cardiologico Monzino",1,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":118},"100415327","choice-of-optimal-transcatheter-treatment-for-mitral-insufficiency-registry-100415327","NCT04688190","CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry","Choice of Optimal Transcatheter Treatment for Mitral Insufficiency Registry","CHOICE-MI","Inclusion Criteria:\n\n* clinically significant mitral insufficiency\n* patient underwent screening for TMVI\n* echocardiography data at baseline (and after TMVI, E2E and surgery)\n* follow-up of at least 30 days\n\nExclusion Criteria:\n\n\\- age under 18 years",{"count":18,"type":19},"This multinational, investigator-initiated registry aims to investigate clinical outcomes of patients undergoing transcatheter mitral valve replacement (TMVR). The registry primarily focuses on patients treated with TMVR in real-world clinical practice.\n\nPatients evaluated for TMVR but not undergoing the procedure are no longer systematically included. Historical data may include such patients who subsequently underwent alternative treatments, including transcatheter edge-to-edge repair, mitral valve surgery, or medical\u002Fconservative therapy.",[24,26,87],"2026-05-03",{"date":111,"type":38},"2026-05-07",{"date":113,"type":38},"2020-11-01",{"date":115,"type":19},"2030-12-31",{"name":117,"class":73},"Universitätsklinikum Hamburg-Eppendorf",43,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":97},"100558182","left-atrial-monitoring-in-patients-before-and-after-mitral-surgery---lambda-study-100558182","NCT06547788","LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY","LAMBDA","Inclusion Criteria:\n\n* Patients ≥18 years of age\n* Severe (4+) symptomatic Carpentier Type II MR due to degenerative disease\n* Planned surgical mitral valve repair\n* Right-to-left atrial pressure gradient ≥ 5 mmHg at baseline\n* Pulmonary vascular resistance ≤ 4 Wood units\n\nExclusion Criteria:\n\n* Secondary causes of MR and mixed mitral valve disease\n* Infective endocarditis within 30-days\n* Any prior mitral valve intervention\n* Need for emergency intervention or surgery\n* Left ventricular ejection fraction 2+",{"count":127,"type":19},50,"INTERVENTIONAL",[130],"NA","Mitral valve leakage, or mitral regurgitation (MR), is associated with heart failure symptoms including shortness of breath, fatigue, irregular heart rate. When left untreated, it may cause death. Patients with MR can be divided in two broad groups: those with primary MR, caused by disease of the mitral valve structures, and those with secondary MR, due to dilation of the heart chambers. Our study focuses on patients with primary MR.\n\nThe standard treatment for severe symptomatic primary MR is mitral valve surgery, a type of open-heart surgery. The outcomes following this procedure are excellent, however, a subset of patients continue to experience heart failure symptoms after surgery due to very high pressures in the heart, more specifically in the left atrium, which is one of the four heart chambers. This is called functional mitral stenosis (FMS).\n\nPrevious studies have shown that creating a small opening between the left and right atria can help relieve the pressure inside the left atrium. We would like to determine whether creating this opening between the two atria at the time of mitral valve surgery can help prevent FMS. To answer this question, we will study two groups of patients who need mitral valve surgery for primary MR. The first group will undergo mitral valve surgery, along with the creation of the opening between the two atria. The second group will undergo mitral valve surgery alone. We will then compare the outcomes between both groups, namely with regards to their heart failure symptoms after open-heart surgery.",[24,26,133],"Heart Failure","NOT_YET_RECRUITING","2026-04-29",{"date":137,"type":38},"2026-05-06",{"date":139,"type":19},"2026-09-30",{"date":141,"type":19},"2030-01-31",{"name":143,"class":73},"Ottawa Heart Institute Research Corporation",{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":128,"phases":154,"briefSummary":155,"conditions":156,"keywords":157,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":168},"100393852","the-mitral-ii-pivotal-trial-mitral-implantation-of-transcatheter-valves-100393852","NCT04408430","The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).","The Safety and Effectiveness of the Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA (SAPIEN 3\u002FUltra\u002FRESILIA) Valve in Patients With Symptomatic Severe Calcific Mitral Valve Disease With Severe Mitral Annular Calcification Who Are Not Candidates for Standard Mitral Valve Surgery.","MITRAL-II","Inclusion Criteria:\n\nAll Candidates must meet the following criteria:\n\n1. \\- 18 years of age or older\n2. -Severe mitral annular calcification with symptomatic mitral valve dysfunction including severe mitral stenosis defined as mitral valve area (MVA) of ≤1.5 cm2, or ≥ moderate to severe mitral regurgitation, or mixed ≥ moderated stenosis and ≥ moderate regurgitation. For this study, the severity of mitral regurgitation will be graded according to the 2017 American Society of Echocardiography Guidelines: None, Trivial, Mild 1(+), Moderate 2(+), Moderate to severe 3(+), and severe 4(+).\n3. \\- NYHA Functional Class ≥II.\n4. The heart team agrees that valve implantation will likely benefit the patient.\n5. High or prohibitive risk for standard mitral valve surgery as determined by the heart team (at least one site cardiac surgeon must personally examine the subject to determine operative risk in patients presented for inclusion to ViMAC arm). NOTE: Patients not interested in mitral intervention or who are being considered for inclusion in the Natural History of Disease Registry are not required to be evaluated in person by a surgeon.)\n6. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.\n7. The study patient agrees to comply with all required post-procedure follow-up visits including annual visits through 5 years.\n\nExclusion Criteria for ViMAC subjects (does not apply to the Natural History of Disease Registry):\n\n1. \\- The heart team considers the patient is a surgical candidate.\n2. \\- Mitral annulus is not severely calcified.\n3. \\- Myocardial infarction requiring revascularization within 30 days from procedure.\n4. \\- Clinically significant untreated coronary artery disease requiring revascularization.\n5. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker is not exclusionary.\n6. Any patient with a balloon valvuloplasty (BMV) within 30 days of the procedure (unless BMV is a bridge to ViMAC procedure after a qualifying Echo).\n7. Severe symptomatic tricuspid regurgitation (hepatic dysfunction, ascites, edema not controlled with diuretics) requiring surgery.\n8. Leukopenia (WBC \\\u003C 3000 cell\u002FmL), acute anemia (Hgb \\\u003C 9 g\u002FdL), Thrombocytopenia (Platelets \\\u003C 50,000 cell\u002FmL), history of coagulopathy or hypercoagulable state.\n9. Hypertrophic obstructive cardiomyopathy (HOCM) with mean LVOT gradient of ≥20 mm Hg at rest or ≥50 mmHg with Valsalva.\n10. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of screening evaluation.\n11. Need for emergency surgery for any reason.\n12. Severe left ventricular dysfunction with LVEF \\\u003C 20%.\n13. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.\n14. Active upper GI bleeding within 90 days prior to procedure.\n15. A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure.\n16. Cardiac anatomy that would preclude appropriate delivery and deployment of an Edwards SAPIEN 3\u002FUltra\u002FRESILIA valve in MAC via transseptal access, including but not limited to:\n\n    * Native neo mitral annulus size \\\u003C 275 mm2 or \\> 810 mm2 as measured by CT scan.\n    * Significant risk of LVOT obstruction or valve embolization as assessed by CT core lab\n17. Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 90 days of the procedure.\n18. Estimated life expectancy \\\u003C12 months due to non-cardiac conditions.\n19. Expectation that patient will not improve despite treatment of mitral valve dysfunction.\n20. Active bacterial endocarditis within 180 days of procedure.\n21. \\- Severe right ventricular dysfunction as assessed by Echo core lab\n22. \\- Active infection requiring antibiotic therapy (subject may be a candidate after 2 weeks of antibiotic discontinuation.\n23. \\- Female who is pregnant or lactating.\n24. \\- Participating in another investigational device study.\n25. \\- Aortic valve disease requiring intervention. If aortic valve intervention is required, the AVR procedure should be performed first and if the patient remains symptomatic after AVR, may be presented for consideration for inclusion in this trial.\n26. \\- Severe fixed pulmonary hypertension (PASP ≥70 mmHg and more than 2\u002F3 of the systemic systolic blood pressure).\n27. \\- Severe chronic obstructive pulmonary disease requiring continuous home oxygen.\n28. \\- The patient refuses mitral valve intervention\n29. \\- Recent symptomatic COVID-19 infection with residual symptoms that may affect the outcomes of this trial.",{"count":153,"type":19},210,[130],"A prospective multicenter study enrolling high surgical risk patients with severe mitral annular calcification (MAC) and symptomatic mitral valve dysfunction (severe stenosis, ≥ moderate to severe regurgitation, or mixed ≥ moderate stenosis and ≥ regurgitation). There are 2 Arms in this study: 1) \"Transseptal (TS) Valve-in-MAC\" (ViMAC) Arm, and 2) Natural History of Disease Registry (NHDR) for patients treated with medical treatment only (which includes patients who meet inclusion criteria but can't be treated with transeptal ViMAC due to the presence of anatomical exclusion criteria or other exclusion criteria) and have not had other procedures that may impact outcomes (i.e., alcohol septal ablation or radiofrequency ablation). The study also includes a Registry of Permanently Unassigned\" for subjects who undergo preemptive septal ablation procedures (alcohol or radiofrequency) in anticipation of continuing onto ViMAC arm, but are not accepted in the ViMAC Study arm or the patient chooses not to undergo ViMAC procedure.",[87,25,24,26],[158],"Transcatheter Mitral Valve Replacement","2026-01-12",{"date":161,"type":38},"2026-01-13",{"date":163,"type":38},"2021-03-08",{"date":165,"type":19},"2030-12",{"name":167,"class":73},"Mayra Guerrero",17,{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":128,"phases":178,"briefSummary":179,"conditions":180,"keywords":181,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":4},"100528933","alliance-mitral-safety-and-effectiveness-of-sapien-x4-transcatheter-heart-valve---mitral-100528933","NCT06167213","ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral","Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve - Mitral","Inclusion Criteria:\n\n1. Failing mitral surgical bioprosthetic valve or a failing native mitral valve with an annuloplasty ring demonstrating ≥ moderate stenosis and\u002For ≥ moderate insufficiency\n2. Bioprosthetic surgical valve or native mitral annulus size suitable for SAPIEN X4 THV\n3. NYHA functional class ≥ II\n4. Heart Team agrees the subject is at high or greater surgical risk\n5. The subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.\n\nExclusion Criteria:\n\n1. Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system\n2. Interatrial septum or left atrium not suitable for transcatheter transseptal access\n3. Failing valve has mild or greater paravalvular regurgitation\n4. Failing valve is unstable, rocking, or not structurally intact\n5. Annuloplasty ring dehiscence\n6. Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean gradient \\> 10 mmHg at the end of the index procedure for implantation of the original valve\n7. Annuloplasty ring type not favorable for THV implantation\n8. Increased risk of THV embolization\n9. Anatomical characteristics that would increase risk of left ventricular outflow tract (LVOT) obstruction\n10. Surgical or transcatheter aortic valve extending into LVOT that may impinge on the mitral implant\n11. Severe right ventricle (RV) dysfunction\n12. Severe regurgitation or stenosis of any other valve\n13. Need for aortic, tricuspid, or pulmonic valve intervention within the next 12 months\n14. Left ventricular ejection fraction \\\u003C 20%\n15. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation\n16. Myocardial infarction within 30 days prior to the study procedure\n17. Hypertrophic cardiomyopathy with subvalvular obstruction\n18. Subjects with planned concomitant ablation for atrial fibrillation\n19. Clinically significant coronary artery disease requiring revascularization\n20. Any surgical or transcatheter procedure within 30 days prior to the study procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator (ICD) is not considered an exclusion.\n21. Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure\n22. Endocarditis within 180 days prior to the study procedure\n23. Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure\n24. Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure\n25. Renal insufficiency and\u002For renal replacement therapy\n26. Leukopenia, anemia, thrombocytopenia\n27. Inability to tolerate or condition precluding treatment with antithrombotic therapy\n28. Hypercoagulable state or other condition that increases risk of thrombosis\n29. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication\n30. Subject refuses blood products\n31. Body mass index \\> 50 kg\u002Fm2\n32. Estimated life expectancy \\\u003C 24 months\n33. Female who is pregnant or lactating\n34. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments\n35. Participating in another investigational drug or device study that has not reached its primary endpoint\n36. Subject considered to be part of a vulnerable population",{"count":177,"type":19},125,[130],"This study will establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater surgical risk with a failing mitral surgical bioprosthetic valve or a failing native mitral valve with an annuloplasty ring.",[24,26,25],[182,183,184],"SAPIEN X4","Valve-in-Valve","Valve-in-Ring","2025-12-18",{"date":187,"type":38},"2025-12-22",{"date":189,"type":19},"2027-01",{"date":191,"type":19},"2038-03",{"name":193,"class":45},"Edwards Lifesciences",{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":204,"conditions":205,"keywords":217,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":229},"100613478","cohort-observing-mechanisms-progression-and-sequelae-of-valvular-heart-disease-100613478","NCT07267117","Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease","Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease (VALVE-COMPASS)","VALVE-COMPASS","Inclusion Criteria:\n\n* At least 18 years old;\n* Be willing and able to provide informed consent to participate in the study;\n* Patients with heart valve disease diagnosed by echocardiography who meet one of the following criteria:\n\n  1. Grade II or higher Aortic valve regurgitation: regurgitant jet width \\>3 mm, jet width \u002F LVOT diameter ≥25%, jet cross-sectional area\u002FLVOT cross-sectional area ≥5%, effective regurgitant orifice area (EROA) ≥0.1 cm², regurgitant volume per beat (R Vol)≥30 ml, or regurgitant fraction (RF) ≥30%.\n  2. Moderate or higher aortic valve stenosis: peak velocity ≥3.0 m\u002Fs, Mean gradient ≥20 mm Hg, aortic valve area ≤1.5 cm², Indexed aortic valve area ≤0.85 cm²\u002Fm², or velocity ratio ≤0.50.\n  3. Grade II or higher mitral valve regurgitation: regurgitant jet width ≥3 mm, regurgitant volume per beat ≥30 ml, regurgitant jet area\u002Fleft atrial area \\>30%, or effective regurgitant orifice area (EROA) ≥0.2 cm².\n  4. Moderate or higher valve stenosis: valve area (specific finding) ≤1.5 cm², or mean gradient (supportive finding) ≥10.0 mmHg.\n  5. Grade II or higher tricuspid valve regurgitation: regurgitant jet width ≥3 mm, proximal isovelocity surface area ≥6 mm, effective regurgitant orifice area (EROA) ≥0.2 cm², or regurgitant volume per beat ≥30 ml.\n  6. Significant tricuspid valve stenosis: mean pressure gradient ≥5.0 mmHg, inflow time-velocity integral \\>60 cm, T1\u002F2 ≥190 ms, or valve area ≤1.0 cm².\n  7. Grade II or higher pulmonary valve regurgitation: regurgitant jet width \\>3 mm, regurgitant volume per beat ≥30 ml, regurgitant fraction ≥30%, or effective regurgitant orifice area (EROA) ≥0.1 cm².\n  8. Moderate or higher Pulmonary valve stenosis: pulmonary valve transvalvular pressure gradient ≥40 mmHg, right ventricular systolic pressure ≥60 mmHg, or pulmonary valve opening \\\u003C1.5 cm².\n\nExclusion Criteria:\n\n* Patients who are unwilling to accept registration and follow-up;\n* Patients who cannot cooperate with information collection and follow-up due to mental illness or other conditions;\n* Patients whose life expectancy is less than 12 months due to non-cardiac diseases (such as cancer, liver disease, kidney disease, or end-stage lung disease).",{"count":203,"type":19},10000,"The objective of this study is to evaluate and predict the progression of moderate cardiac valve stenosis and regurgitation using clinical, biological, echocardiographic, computed tomography (CT), and magnetic resonance imaging (MRI) data. Additionally, the study aims to analyze the potential impact of device-based interventions, pharmacological therapy, and lifestyle modifications on disease progression.",[206,27,26,207,208,209,210,211,212,213,30,214,215,216],"Heart Valve Disease","Mitral Valve Stenosis","Aortic Valve Disease","Aortic Valve Stenosis","Tricuspid Valve Disease","Tricuspid Valve Regurgitation","Aortic Valve Regurgitation","Pulmonary Valve Disease","Transcatheter Aortic Valve Replacement (TAVR)","Transcatheter Pulmonary Valve Replacement (TPVR)","Transcatheter Edge-to-edge Repair",[218,219],"Heart Valve Disease Progression","Heart Valve disease sequelae","2025-11-25",{"date":222,"type":38},"2025-12-05",{"date":224,"type":38},"2025-06-01",{"date":226,"type":19},"2030-05-31",{"name":228,"class":73},"Second Affiliated Hospital, School of Medicine, Zhejiang University",15,{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":239,"conditions":240,"keywords":242,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":258},"100558937","safety-and-efficacy-of-the-coolcryo-system-for-cardiac-cryoablation-in-the-treatment-of-atrial-fibrillation-100558937","NCT06557616","Safety and Efficacy of the CoolCryo System for Cardiac Cryoablation in the Treatment of Atrial Fibrillation","Evaluation of the Safety and Efficacy of the CoolCryo System for Cardiac Cryoablation in the Treatment of Atrial Fibrillation in a Single-arm, Non-randomised, Open-label Clinical Trial","CoolCryo","Inclusion Criteria:\n\n1. Written consent from the patient to participate in the study.\n2. age ≥18 years.\n3. patient qualified for mitral valve surgery (mitral valve plication or mitral valve replacement \"with\" or \"without\" left atrial appendage closure).\n4. a documented diagnosis of co-occurrence of paroxysmal or persistent atrial fibrillation (AF) since at least 3 months prior to surgery with exclusion of acute conditions.\n\nExclusion Criteria:\n\n1. Lack of written consent from the patient to participate in the study.\n2. Failure to meet the inclusion criteria.\n3. Contraindications to the cryoablation procedure.\n4. Patient breastfeeding, pregnant or planning pregnancy within 6 months of study treatment.\n5. co-morbidities and\u002For conditions that may cause atrial fibrillation (uncompensated hyperthyroidism or hypothyroidism, acute infection, pheochromocytoma, significant dyselectrolitemia).\n6. significant calcification of the left atrium.\n7. Condition after previous cardiac surgery.\n8. significant left atrial enlargement (size greater than 10 cm on echocardiography in one of the projections performed). projection).\n9. the patient is currently a participant in another clinical trial.\n10. The patient is on active biological therapy.\n11. emergency surgery.\n12. Life expectancy \\\u003C12 months.\n13. Any circumstances that, in the opinion of the Investigator, may prevent the patient from participating in the study, limit the ability to perform the procedures outlined in the study protocol or place an unreasonable risk on the patient.",{"count":5,"type":19},"The study involves endocardial cryoablation of the left and\u002For right atrium of the heart using the CoolCryo system as an adjunct to mitral valve surgery, with the aim of eliminating atrial fibrillation (AF), which is a common sequelae of mitral valve defects and is associated with an increased risk of ischaemic stroke, heart failure and death.",[241,26],"Atrial Fibrillation, Paroxysmal or Persistent",[243,244,245,246,247,248],"cryoablation","cardiac cryoablation","arrhythmia","atrial fibrillation","mitral valve","concomitant ablation","2025-09-19",{"date":251,"type":38},"2025-09-23",{"date":253,"type":38},"2024-07-03",{"date":255,"type":19},"2026-06-30",{"name":257,"class":45},"Medinice S.A.",2,{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":267,"targetDuration":268,"studyType":21,"phases":4,"briefSummary":269,"conditions":270,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":280},"100419049","mitral-valve-screening-survey-100419049","NCT04736667","Mitral Valve Screening Survey","Mitral Valve Screening Survey (MVSS)","MVSS","Inclusion Criteria:\n\n* Subject failed screening for TMVI\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Subject unable or unwilling to give informed consent\n* Subject proceeded with TMVI.",{"count":18,"type":19},"5 Years","This study aims to examine the clinical profile\u002Fanatomical characteristics and natural history of patients who subsequently fail screening for transcatheter mitral valve intervention (TMVI).",[26],"2025-08-25",{"date":273,"type":38},"2025-08-29",{"date":275,"type":38},"2021-08-06",{"date":277,"type":19},"2027-02",{"name":279,"class":73},"Medstar Health Research Institute",16,{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":15,"minAge":289,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":128,"phases":292,"briefSummary":293,"conditions":294,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":97},"100600457","early-feasibility-study-of-surgical-implantation-of-a-polymer-prosthetic-mitral-and-aortic-valve-100600457","NCT07097740","Early Feasibility Study of Surgical Implantation of a Polymer Prosthetic Mitral and Aortic Valve","A Prospective Early Feasibility Clinical Study of Surgical Implantation of a Polymer Prosthetic Heart Valve","POLYVALVE-FIH","Inclusion Criteria:\n\n* Adults requiring surgical replacement of either mitral or aortic valve\n* Capable of undergoing cardiopulmonary bypass\n* Able to tolerate anticoagulation therapy\n* Able to understand study purpose, willing to provide informed consent and comply with follow-up\n\nExclusion Criteria:\n\n1. History of previous cardiac valve surgery or percutaneous valve replacement, including surgical aortic or mitral valve replacement (excluding Percutaneous Balloon Mitral Valvuloplasty \\[PBMV\\], which is permitted).\n2. Requirement for urgent or emergency cardiac surgery.\n3. Planned concurrent aortic valve surgery or combined valve procedure (e.g., simultaneous aortic and mitral valve surgery).\n4. Scheduled coronary artery bypass graft (CABG) during the same admission.\n5. Anticipated need for additional non-valve cardiac surgery within 12 months.\n6. Active systemic infection, including pneumonia or infective endocarditis.\n7. Intracardiac thrombus detected on echocardiography or imaging.\n8. Stroke or transient ischemic attack within the prior 3 months.\n9. Myocardial infarction, unstable coronary syndrome, or coronary revascularization within the prior 3 months.\n10. Severe comorbidities with expected life expectancy \\\u003C12 months, including Child-Pugh C liver disease, end-stage malignancy, or advanced pulmonary disease.\n11. Participation in another interventional clinical trial involving investigational devices or drugs.\n12. Anatomical risk factors such as ascending aortic aneurysm (≥50 mm), bicuspid aortic valve with ascending aorta ≥45 mm, or other high-risk features identified on imaging.\n13. Left ventricular ejection fraction (LVEF) ≤35%, indicating severe systolic dysfunction.\n14. Severe renal insufficiency, e.g., estimated GFR \\\u003C30 mL\u002Fmin\u002F1.73 m² or requirement for chronic dialysis.\n15. Coagulopathy or active bleeding disorders, e.g., INR \\>1.5 without anticoagulation therapy.\n16. Hematologic abnormalities: hematocrit \\\u003C30%, hemoglobin \\\u003C100 g\u002FL, platelet count \\\u003C100 × 10⁹\u002FL, or WBC \\\u003C4 × 10⁹\u002FL or \\>10 × 10⁹\u002FL.\n17. History of substance abuse, chronic alcoholism, or significant psychiatric illness impairing study compliance.\n18. Preoperative or intraoperative anatomical unsuitability of the valve apparatus or cardiac structure.\n19. Known allergy or hypersensitivity to polyurethane, polyester, or sulfonate-based biomaterials used in the valve prosthesis.\n20. Withdrawal from the study after valve implantation (such participants are not allowed to re-enroll).","50 Years",{"count":291,"type":19},10,[130],"The goal of this clinical trial is to explore the early feasibility, initial safety, and efficacy of surgical implantation of a polymer prosthetic heart valve in patients requiring either mitral valve replacement or aortic valve replacement.\n\nThe main question it aims to answer is:\n\n\\-- What is the rate of valve-related complications, including thromboembolism, valve thrombosis, severe perivalvular leak, severe bleeding, and endocarditis, at 12 months post-operation?\n\nParticipants will undergo:\n\n* Surgical implantation of a polymer prosthetic valve (mitral valve replacement for mitral valve group and aortic valve replacement for aortic valve group).\n* Regular follow-up visits at 30 days, 3-6 months, and 12 months post-operation to evaluate clinical outcomes, including echocardiographic assessment and clinical event monitoring.",[295,26,296,297,25,24],"AORTIC VALVE DISEASES","Aortic Stenosis","Aortic Regurgitation","2025-07-24",{"date":300,"type":38},"2025-07-31",{"date":302,"type":38},"2025-06-27",{"date":304,"type":19},"2027-06",{"name":306,"class":45},"Mitrassist Lifesciences Limited Co., Ltd.",{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":15,"minAge":314,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":317,"conditions":318,"keywords":319,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":97},"100527884","evaluation-of-the-elasticity-of-the-mitral-valve-100527884","NCT06153563","Evaluation of the Elasticity of the Mitral Valve","Evaluation of the Elasticity of the Mitral Valve Chordae by Uniaxial Traction in the Context of Mitral Valve Regurgitation With a Comparison of the Results: Mitral Valve Prolapse vs Restriction of Mitral Valve Movement","Inclusion Criteria:\n\nAll patients programmed for mitral valve replacement who have more than 45 years old\n\nExclusion Criteria:\n\n* Patients with mitral calcification\n* Mitral valve rheumatic disease\n* Mitral valve infections\n* Redo surgery on the mitral valve","45 Years",{"count":316,"type":19},30,"There is no information in the literature on the mechanobiological characteristics of mitral valve chords in living humans. All examinations were carried out on tissues taken from animals, either from cadavers or from frozen human tissues. The objective is to determine mechanobiological and histological characteristics of the mitral valve chords in living humans, as well as to compare differences in elasticity in different groups (Group A: patients with mitral valve prolapse versus Group B: patients with restrictive ischemic mitral valve).",[26],[320,321,322,323,324],"Mitral valve","mitral valve chords","elasticity","Young's modulus","mitral valve histology","2025-01-03",{"date":327,"type":38},"2025-01-06",{"date":329,"type":38},"2021-10-18",{"date":331,"type":19},"2025-03",{"name":333,"class":73},"Centre Hospitalier Universitaire de Saint Etienne",{"id":335,"slug":336,"hasResults":11,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":340,"eligibilityCriteria":341,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":342,"enrollmentInfo":343,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":345,"conditions":346,"keywords":347,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":97},"100518023","the-study-on-the-use-of-uniline-bioprosthesis-in-the-treatment-of-isolated-aortic-and-mitral-valve-diseases-100518023","NCT06025149","The Study on the Use of \"UniLine\" Bioprosthesis in the Treatment of Isolated Aortic and Mitral Valve Diseases","Open, Prospective, Multicenter Study of the Safety and Efficacy of \"UniLine\" Epoxy-treated Prosthesis Made From Xenopericardium in the Treatment of Isolated Aortic and Mitral Valve Diseases","Uniline","Inclusion Criteria:\n\n1. Provided informed consent to participate in the study.\n2. Must be aged 18 years and older.\n3. Patients with isolated acquired mitral or aortic valve disease.\n4. No prior heart valve replacement, current replacement must be planned (not conducted in an urgent\u002F emergency manner), using the \"UniLine\" biological prosthesis made from xenopericardium.\n5. Patient must be able to visit the Research Center.\n\nExclusion Criteria:\n\n1. Mechanical or biological prosthesis in another position. Patients with tricuspid valve repair may be included in the study.\n2. Prior heart valve replacement.\n3. Concomitant interventions on the heart (coronary artery bypass grafting, coronary heart disease treatment, surgical reconstruction of a left ventricular aneurysm) and thoracic aorta.\n4. Patients with cancer in history.\n5. Patients with musculoskeletal conditions with severe movement disorders and diseases of the central nervous system, accompanied by cognitive disorders (disorientation, inability to independently reach the destination).\n6. Acute or subacute stages of infective endocarditis.\n7. Class IV heart failure according to the New York Heart Association Functional Classification with ongoing therapy, left ventricular ejection fraction less than 40%, myocardial infarction less than 90 days old, angina pectoris grade 4.\n8. The presence of severe somatic, neurological, mental and infectious diseases that worsen the prognosis of long-term survival: tuberculosis, human immunodeficiency virus, Alzheimer's disease, epilepsy, chronic kidney disease stage 3b (Glomerular Filtration Rate less than 30 mL\u002F min \u002F 1.73 m²), chronic lung diseases requiring constant intake of corticosteroids and bronchodilators, multifocal atherosclerosis (grade 3 chronic lower limb ischemia, stenosis of the carotid arteries more than 50%, prior and planned interventions on the abdominal aorta, carotid arteries or arteries of the lower extremities).","80 Years",{"count":344,"type":19},300,"The goal of this open, prospective, multicenter study is analyze long-term outcomes of aortic\u002Fmitral valve replacement using the \"UniLine\" bioprosthesis in patients with acquired aortic or mitral valve diseases.\n\nMain research objectives:\n\nTo analyze long-term (up to 12 years) outcome of aortic or mitral valve replacement using the \"UniLine\" bioprosthesis.\n\nTo study the hemodynamic characteristics of normally functioning \"UniLine \" prostheses in the mitral or aortic valve position based on the transthoracic echocardiography data.\n\nTo assess the number, type, time frames of dysfunctions of UniLine bioprostheses and the results of their treatment.\n\nTo analyze the frequency of major serious adverse events associated with the \"UniLine\" bioprosthesis or procedure.",[208,26],[348,349,350,351],"UniLine biological prosthesis","Acquired valve disease","Acquired aortic valve disease","Acquired mitral valve disease","2024-09-24",{"date":354,"type":38},"2024-09-25",{"date":356,"type":38},"2018-09-01",{"date":358,"type":19},"2035-01-31",{"name":360,"class":73},"Closed Joint-Stock Company NeoCor",{"id":362,"slug":363,"hasResults":11,"nctId":364,"briefTitle":365,"officialTitle":365,"acronym":4,"eligibilityCriteria":366,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":367,"targetDuration":4,"studyType":128,"phases":368,"briefSummary":369,"conditions":370,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":97},"100516205","the-effects-of-360-degree-virtual-reality-on-pre-procedural-anxiety-in-patients-awaiting-elective-cardiac-surgery-involving-a-sternotomy-100516205","NCT06001489","The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy","Inclusion Criteria:\n\n* Patients awaiting elective cardiac surgery involving a sternotomy\n* 18 years or older\n\nExclusion Criteria:\n\n* Under the age of 18\n* History of previous cardiac surgery\n* (concomitant) aortic surgery\n* Cardiac surgery for congenital heart defects\n* Hearing or visual impairments\n* Language barriers (inability to understand, speak or read Dutch)\n* History of severe mental or psychiatric disorders",{"count":84,"type":19},[130],"Rationale: Patients awaiting cardiac surgery can experience pre-procedural anxiety. This anxiety is associated with increased analgesic needs, increased risk of mortality and prolonged recovery time. Adequate patient education can help diminish pre-procedural anxiety and minimize postoperative complications. Recent studies have demonstrated that Virtual Reality (VR) can function as a useful tool to diminish pre-procedural anxiety in several medical fields. Especially 360 degree VR could familiarize patients with their clinical pathway. Nevertheless, limited to no research on the application of 360 degree VR has been conducted in the context of cardiothoracic surgery yet.\n\nObjective: The aim of this study is to explore the effects and possible benefits of 360 degree VR on pre-procedural anxiety in patients awaiting elective cardiac surgery involving a sternotomy, compared to standard forms of patient education.\n\nStudy design: Single-center, randomized controlled trial\n\nStudy population: Patients aged 18 or older awaiting elective cardiac surgery involving a sternotomy.",[371,208,26,210],"Cardiac Valve Disease","2024-07-09",{"date":374,"type":38},"2024-07-10",{"date":376,"type":38},"2023-07-01",{"date":378,"type":19},"2024-12",{"name":380,"class":73},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",{"id":382,"slug":383,"hasResults":11,"nctId":384,"briefTitle":385,"officialTitle":385,"acronym":386,"eligibilityCriteria":387,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":388,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":390,"conditions":391,"keywords":401,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":97},"100534173","european-association-of-cardiovascular-imaging-multiple-and-mixed-valvular-disease-study-100534173","NCT06235385","European Association of Cardiovascular Imaging Multiple and Mixed Valvular Disease Study","EACVI-MMVD","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Patient referred to the cardiovascular imaging department.\n3. Diagnosis of MMVD confirmed by transthoracic echocardiography, defined as:\n\n   1. Multiple VHD: at least 2 moderates to severe VHD involving ≥ 2 different valves, using the current ESC guidelines.\n\n      and\u002For\n   2. Mixed VHD: at least moderate stenosis and at least moderate regurgitation of a single valve, using the current ESC guidelines.\n4. Patient not refusing to have their data involved in the protocol after information.\n\nExclusion Criteria (patients fulfilling any of the following criteria are not eligible for inclusion in this study):\n\n1. History of prior valve surgery or percutaneous valve intervention (concerning a valve other than those involved in the definition of MMVD).\n2. Acute infective endocarditis at the time of evaluation for inclusion (confirmed according to modified Duke criteria) or history of endocarditis ≤ 6 months.\n3. Complex congenital heart diseases.",{"count":389,"type":19},1500,"This study aims to investigate the prevalence and characteristics of multiple and mixed valvular heart disease (MMVD), which includes combinations of stenotic or regurgitant lesions on cardiac valves. The research will be conducted as a multicenter observational study, involving several centers worldwide, and will have a one-year follow-up period (with a possible extension to 5 years). The primary aim is to determine the proportion of MMVD among patients evaluated for valvular heart disease. Secondary aims include the evaluation of the epidemiologic distribution of clinical, biological, and cardiovascular imaging characteristics at baseline, management strategies, and their impact on prognosis. The study will also evaluate clinical outcomes such as mortality, hospitalization for heart failure, and changes in echocardiographic parameters. This research aims to provide valuable insights into the diagnosis, management, and prognosis of MMVD, addressing an important knowledge gap in this area.",[392,393,208,209,394,26,207,395,396,397,398,399,210,400],"Heart Valve Diseases","Multiple Valve Disease, Unspecified","Aortic Valve Insufficiency","Mitral Valve Insufficiency and Aortic Valve Insufficiency","Mitral Valve Insufficiency","Aortic Valve Stenosis With Insufficiency","Mitral Valve Disease Mixed","Tricuspid Valve Insufficiency","Tricuspid Stenosis",[402,403],"Multiple Valvular Heart Disease","Mixed Valvular Heart Disease","2024-05-31",{"date":406,"type":38},"2024-06-03",{"date":408,"type":38},"2024-02-07",{"date":410,"type":19},"2029-08-01",{"name":412,"class":73},"Assistance Publique - Hôpitaux de Paris",{"id":414,"slug":415,"hasResults":11,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":419,"eligibilityCriteria":420,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":421,"targetDuration":4,"studyType":128,"phases":422,"briefSummary":423,"conditions":424,"keywords":4,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":97},"100524793","explore-mrace-early-feasibility-experience-of-posterior-leaflet-restoration-to-reduce-mitral-regurgitation-using-the-mrace-implant-100524793","NCT06113354","EXPLORE MRace: Early Feasibility Experience of Posterior Leaflet Restoration to Reduce Mitral Regurgitation Using the MRace Implant","Early Feasibility Experience of Posterior Leaflet Restoration to Reduce Mitral Regurgitation Using the MRace Implant (EXPLORE MRace)","EXPLORE MRace","Inclusion Criteria:\n\n1. 18 years of age or older\n2. Greater than moderate mitral regurgitation (Grade 3+ or higher) as confirmed by transesophageal echocardiography (TEE) within 90 days prior to study procedure\n3. Patient must present with an STS Score less than 10%\n4. High surgical risk for conventional mitral repair or replacement due to morphological criteria (e.g. leaflet or annulus calcifications), but operable, as assessed by the local heart team comprised of a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in treating mitral valve disease and heart failure\n5. New York Heart Association (NYHA) Functional Class III or IV\n6. Patient willing to participate in study and provide signed IRB\u002FEC-approved informed consent\n7. Treating physician and patient agree that patient is able to return for all required post-procedure follow-up visits\n\nExclusion Criteria:\n\n1. Severe tricuspid regurgitation\n2. Severe aortic stenosis or insufficiency\n3. Severe mitral annulus calcification\n4. Diseased mitral anterior leaflet such as flail \u002F prolapse\u002F heavy calcification\n5. Implanted vena cava filter\n6. Femoral veins with severe angulation and calcification\n7. Contraindication for transesophageal echocardiography (TEE) or MDCT scan\n8. Active infection or endocarditis\n9. Previous mitral valve surgery\n10. Prior orthotopic heart transplantation\n11. Pulmonary artery systolic hypertension \\> 70mmHg\n12. Evidence of intra-cardiac, inferior vena cava (IVC) or femoral venous thrombus\n13. Left ventricular ejection fraction (LVEF) \\\u003C 30%\n14. Implant or revision of any pacing device \\\u003C 30 days prior to intervention\n15. Symptomatic coronary artery disease treated \\\u003C 30 days prior to study procedure\n16. Myocardial infarction requiring intervention \\\u003C 30 days prior to study procedure\n17. Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis), hypertrophic or restrictive cardiomyopathies, and constrictive pericarditis\n18. Active peptic ulcer or upper gastrointestinal bleeding \\\u003C 90 days prior to study procedure\n19. Stroke \\\u003C 180 days prior to study procedure\n20. Severe renal insufficiency (creatinine \\> 3.0 mg\u002FdL) or patient requiring dialysis\n21. Cardiogenic shock at time of enrolment\n22. Hemodynamic instability requiring inotropic support or mechanical heart assistance\n23. Concurrent medical condition with a life expectancy of less than 2 years\n24. Pregnancy at time of enrolment\n25. History of bleeding diathesis or coagulopathy or leukopenia (WBC \\\u003C 3,000 mcL) or acute anemia (Hb \\\u003C 9 g\u002FdL) or thrombocytopenia (platelets \\\u003C 50,000 cells mcL)\n26. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be pre-medicated\n27. Severe dementia or lack of capacity due to conditions that result in either inability to provide informed consent for the trial\u002Fprocedure, prevent independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up assessments\n28. Emergency situations\n29. Company employees or their immediate family members\n30. Patient is under guardianship\n31. Patient is participating in another clinical study for which follow-up is currently ongoing",{"count":291,"type":19},[130],"An early feasibility study to evaluate the safety and feasibility of the MRace Implant and Delivery System to treat severe mitral regurgitation and to gather preliminary data on its performance thereby providing guidance for future clinical development. The study is a single-arm registry with the last follow-up visit at 5 years post-intervention. The study will enroll up to 10 patients at one (1) center in Brazil.",[26],"2023-11-09",{"date":427,"type":38},"2023-11-13",{"date":429,"type":19},"2023-12",{"date":431,"type":19},"2029-12",{"name":433,"class":45},"Polares Medical SA",{"id":435,"slug":436,"hasResults":11,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":440,"eligibilityCriteria":441,"healthyVolunteers":442,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":443,"targetDuration":4,"studyType":128,"phases":445,"briefSummary":446,"conditions":447,"keywords":448,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":291},"100506253","munich-transcatheter-mitral-valve-safety-and-effectiveness-100506253","NCT05871983","Munich Transcatheter Mitral Valve Safety and Effectiveness","Clinical Evaluation of Safety and Effectiveness of the Munich Transcatheter Mitral Valve Replacement (TMVR) System","MUSE","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Moderate or severe mitral regurgitation (\\> 3+)\n\n   1. For Degenerative MR: EROA ≥ 40 mm2 or regurgitant volume ≥ 60ml\n   2. For Secondary MR: EROA \\> 30 mm2 or regurgitant volume \\> 45ml (i.e., MR moderate or severe by ASE criteria)\n3. New York Heart Association (NYHA) Functional Class II, III or ambulatory IV\n4. Subject is under guideline directed medical therapy for at least one month\n5. Subject is high-risk for open-heart surgery based on the assessment of the multidisciplinary Heart Team using standard scoring systems and consideration of co-morbidities, frailty and disability\n6. Subject meets the anatomical criteria for Munich TMVR System\n7. Patient is willing to participate in the study and provides signed informed consent.\n\nExclusion Criteria:\n\nGeneral Conditions\n\n1. Subject who is currently participating in an investigational study, other than this study\n2. Subjects allergic to bovine tissue\n3. Subjects with uncontrolled hypotension\n4. Hemodynamic instability\n5. Subject has contrast agent hypersensitivity that cannot be adequately pre-medicated and has an allergy to Nitinol alloys\n6. Intolerance to antiplatelet, anticoagulant or thrombolytic medications\n7. Bleeding diathesis or hypercoagulable state\n8. Active peptic ulcer or active gastrointestinal bleeding\n9. Pulmonary artery systolic pressure \\>70 mmHg\n10. Renal insufficiency\n11. Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.\n12. Subject with hepatic insufficiency\n13. Subject has a co-morbid illness that may result in a life expectancy of less than one year\n14. Active infection that requires antibiotic therapy\n15. Subject is pregnant, breastfeeding or intend to become pregnant within one year, and female subjects in childbearing age NOT using a highly effective method of contraception with a failure rate of less than 1% per year.\n\n    Comorbidities\n16. Prior stroke or TIA within 3 months or Modified Rankin Scale ≥4 disability\n17. Acute myocardial infarction within the previous 30 day\n18. Any prior heart valve surgery or transcatheter mitral intervention\n19. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days\n20. Rheumatic heart disease or endocarditis within the previous 3 months\n21. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis\n22. Severe organic lesion with retracted chordae or congenital malformation and lack of valvular tissue\n23. Any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.\n24. Existence of inferior vena cava filter or atrial septal device (contraindicating femoral access and transseptal catheterization)\n25. Untreated clinically significant coronary artery disease requiring revascularization\n26. Tricuspid valve disease requiring surgery or severe tricuspid regurgitation\n27. Aortic or pulmonic valve disease requiring surgery\n28. CRT\u002FICD implant within 30 days\n29. NYHA class IVb\n30. UNOS stadium 1 heart transplantation or previous orthotopic heart transplantation\n\n    Anatomical and Functional\n31. Left Ventricular Ejection Fraction (LVEF) \\\u003C30%\n32. LV end diastolic diameter \\> 70mm\n33. Significant abnormalities of the sub-valvular apparatus.\n34. Severe mitral annular or leaflets calcification\n35. Left atrial or LV thrombus or vegetation\n36. Severe right ventricular dysfunction\n37. Severe tricuspid or aortic valve disease",true,{"count":444,"type":19},60,[130],"The Munich Trascatheter Mitral Valve System is intended for beating heart, mitral valve replacement in patients with a diseased, damaged, or malfunctioning mitral valve. Access is provided through the Femoral Vein and transseptal approach by means of a 27Fr catheter.\n\nThe bioprosthetic valve consists of a self-expanding, tri-leaflet, dry bovine-pericardial valve. The dry tissue allows the valve to be conveniently pre-loaded. The valve is available in three sizes and has been designed to reduce the complexity of implantation in comparison to other TMVR systems.",[24,26],[449,450],"mitral regurgitation","heart failure","2023-07-07",{"date":453,"type":38},"2023-07-11",{"date":455,"type":19},"2023-07-30",{"date":457,"type":19},"2029-12-30",{"name":459,"class":45},"P+F Products + Features GmbH",{"id":461,"slug":462,"hasResults":11,"nctId":463,"briefTitle":464,"officialTitle":464,"acronym":4,"eligibilityCriteria":465,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":466,"targetDuration":4,"studyType":128,"phases":468,"briefSummary":469,"conditions":470,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":97},"100435759","transcatheter-mitral-valve-intervention-single-center-registry-in-chinese-patients-with-mitral-valve-disease-torch-m-100435759","NCT04954404","Transcatheter Mitral Valve InterventiOn Single Center Registry in CHinese Patients With Mitral Valve Disease (TORCH-M)","Inclusion Criteria:\n\n1. Patients with mitral valve disease, as determined by the site from a transthoracic echocardiogram (TTE), and in the judgment of the investigator intervention is likely to provide clinical benefit for the patient.\n2. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.\n3. The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed.\n4. Patients are technical and anatomical eligible for interventions.\n\nExclusion Criteria:\n\n1. In the judgment of the investigator, subjects are not anatomical eligible for interventions.\n2. Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically.\n3. Active endocarditis or active rheumatic heart disease.\n4. History of severe bleeding diathesis or coagulopathy or subject will refuse blood transfusions.\n5. Subject has any kind of conditions that might prevent patients benefiting from therapeutic benefit (i.e., Severe mental illness) or life expectancy is less than one year.\n6. Subject has any kind of disorder per investigator's judgement that compromises his\u002Fher ability to give written informed consent and\u002For to comply with study procedures.",{"count":467,"type":19},2000,[130],"The purpose of this study is to evaluate the safety and effectiveness of transcatheter mitral valve intervention in Chinese population with mitral valve disease.",[26],"2021-06-29",{"date":473,"type":38},"2021-07-08",{"date":475,"type":38},"2021-05-01",{"date":477,"type":19},"2031-05-01",{"name":228,"class":73},{"id":480,"slug":481,"hasResults":11,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":485,"eligibilityCriteria":486,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":487,"enrollmentInfo":488,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":489,"conditions":490,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":495,"leadSponsor":496,"locationsCount":97},"100432696","hamburg-transcatheter-mitral-valve-replacement-registry-100432696","NCT04914468","Hamburg TranscathEteR Mitral Valve REplacement RegiStry","Hamburg Transcatheter Mitral Valve Replacement Registry","HERMES","Inclusion Criteria:\n\n* Ability to provide written informed consent in accordance with Good Epidemiological Practice and local legislation.\n* Individuals over the age of 18 years.\n* Patients with clinically relevant mitral valve disease, who undergo screening for TMVR.\n\nExclusion Criteria:\n\n* Insufficient knowledge of the German language, to understand study documents and interview without translation\n* Physical or psychological incapability to cooperate in the investigation","110 Years",{"count":344,"type":19},"The Hamburg TranscathEteR Mitral Valve REplacement RegiStry (HERMES) is a prospective clinical cohort registry aiming to gather follow-up information on short- and long-term outcome of patients with mitral valve disease that undergo transcatheter mitral valve replacement (TMVR) screening. In particular, long-term durability and function of implanted bioprosteses is of utmost interest for both patients and clinicians. Moreover, this study aimes to investigate and compare the different treatment strategies patients undergo after successful or unsuccessful screening for TMVR.",[26],"2021-06-02",{"date":493,"type":38},"2021-06-04",{"date":163,"type":38},{"date":115,"type":19},{"name":117,"class":73},{"id":498,"slug":499,"hasResults":11,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":503,"eligibilityCriteria":504,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":505,"targetDuration":268,"studyType":21,"phases":4,"briefSummary":506,"conditions":507,"keywords":509,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":522},"100377136","multicenter-post-market-observational-registry-of-the-neochord-artificial-chordae-delivery-system-100377136","NCT04190602","Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System","The AcChord Study: A Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System","AcChord","Inclusion Criteria:\n\n* Has Grade III Moderate or Grade IV Severe degenerative or mixed disease mitral valve regurgitation\n* Study procedure completed after 31 December 2016\n\nExclusion Criteria:\n\n* Heavily calcified valves\n* Valvular retraction with severely reduced mobility\n* Active bacterial endocarditis\n* Complex mechanism of MR (leaflet perforation, etc.)\n* Significant tethering of leaflets\n* Inflammatory valve disease",{"count":56,"type":19},"The objective of this study is to evaluate the 5-year outcomes of participants with degenerative mitral valve disease treated with the NeoChord Artificial Chordae System, Model DS1000 in a post-market setting.",[24,26,396,508,392],"Mitral Valve Prolapse",[510,511,512,513],"NeoChord","DS1000","Artificial Chordae","Mitral Valve Repair","2020-07-09",{"date":516,"type":38},"2020-07-10",{"date":518,"type":38},"2020-02-09",{"date":520,"type":19},"2027-12",{"name":510,"class":45},5]