[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mitral-annulus-calcification\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mitral-annulus-calcification":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100589281","treating-severe-mitral-valve-annular-or-valvular-calcification-using-shockwave-balloon-smartwave-100589281","NCT06952374","Treating Severe Mitral Valve Annular or Valvular Calcification Using Shockwave Balloon SMARTWAVE","Mitral Valve Lithotripsy Using the SMARTWAVE Balloon for Severe Mitral Annular or Valvular Calcification (SMART-MAC): First in Human Study","SMARTMAC","Inclusion Criteria:\n\n* Age \\>18 and\n* Able to give procedure and study consent and\n* Severe symptomatic mitral stenosis (MVA \\\u003C1.5cm\\^2 derived by 3D planimetry or continuity equation or pressure half time) and\n* Presence of mitral annular calcification or\n* CRHD with severe leaflet calcification with Wilkins score \\>8\n\nExclusion Criteria:\n\n* Baseline \\> moderate MR\n* Intracardiac thrombus as visualized by TEE\n* Pregnant patients. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure.\n* Active infection with bacteremia\n* Current participation in another investigational drug or device study",{"count":56,"type":19},10,"INTERVENTIONAL",[59],"NA","Mitral stenosis (MS) is a heavily symptomatic valvular heart disease. Common causes of MS included chronic rheumatic heart disease (CRHD) and mitral annular calcification (MAC). Current guideline recommends percutaneous balloon mitral valvuloplasty (PBMV) being the first line intervention for rheumatic MS with favorable anatomy. However, severely calcified mitral valve (i.e. those with Wilkins scores\\>8) makes the mitral valve non-pliable and carries high risk of severe mitral regurgitation (MR) (4-19%) with conventional balloon valvuloplasty. MAC is an increasingly recognized disease associated with atherosclerotic risk factors, and a well-recognized valve morphology that responses poorly with PBMV. Besides, conventional open-heart surgery for MAC-associated mitral valve dysfunction carries high mortality. Transcatheter mitral valve replacement with valve-in-MAC has become an alternative in treating these patients. However, valve-in-MAC is not always feasible and still carries operative and 30-day mortality.\n\nIntravascular lithotripsy is an approved adjunct interventional therapy in treating calcified lesions to facilitate stenotic lesion opening in peripheral vascular disease and coronary artery disease. The off-label use of current peripheral lithotripsy balloon in mitral valve as a compassionate treatment or as an adjunct treatment before mitral balloon valvuloplasty and transcatheter mitral valve replacement has been reported with success . A possible mechanism is that lithotripsy preferentially impacts hard tissue, disrupts calcium, and leaves soft tissue undisturbed, improving valve pliability, preventing leaflet damage, and making subsequent valvuloplasty safer. However, the off-label use of multiple peripheral lithotripsy balloons in mitral valve is technically complicated.\n\nSmartWave balloon was specifically designed lithotripsy balloon for calcified aortic stenosis. This first-in-human study aims to apply the SmartWave lithotripsy balloon in treating calcified mitral stenosis due to MAC or severely calcified rheumatic mitral valve.",[28,62],"Rheumatic Heart Disease",[64],"Mitral valve stenosis","2025-04-23",{"date":67,"type":38},"2025-04-30",{"date":69,"type":38},"2025-03-08",{"date":71,"type":19},"2027-03-31",{"name":73,"class":74},"Prince of Wales Hospital, Shatin, Hong Kong","OTHER",1]