[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mitral-annular-calcification\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mitral-annular-calcification":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,63],{"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},"100639190","mitral-valve-calcium-assessment-with-truevue-trans-illumination-3d-rendering-100639190",false,"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","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","OBSERVATIONAL","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.",[25,26],"Mitral Annular Calcification","Mitral Valve Disease","RECRUITING","2026-05-21",{"date":30,"type":31},"2026-05-28","ACTUAL",{"date":33,"type":31},"2025-12-17",{"date":35,"type":21},"2026-06-01",{"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":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":62},"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":49,"type":21},1000,"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.",[52,26,25],"Mitral Regurgitation","2026-05-03",{"date":55,"type":31},"2026-05-07",{"date":57,"type":31},"2020-11-01",{"date":59,"type":21},"2030-12-31",{"name":61,"class":38},"Universitätsklinikum Hamburg-Eppendorf",43,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":90},"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":72,"type":21},210,"INTERVENTIONAL",[75],"NA","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.",[25,78,52,26],"Mitral Stenosis",[80],"Transcatheter Mitral Valve Replacement","2026-01-12",{"date":83,"type":31},"2026-01-13",{"date":85,"type":31},"2021-03-08",{"date":87,"type":21},"2030-12",{"name":89,"class":38},"Mayra Guerrero",17]