[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mitral-valve-incompetence\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mitral-valve-incompetence":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100551873","atlas-altavalve-pivotal-trial-100551873",false,"NCT06465745","ATLAS (AltaValve) Pivotal Trial","ATLAS (A Transseptal Left Atrial System for Treatment of Mitral Regurgitation) Pivotal Trial","ATLAS","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 baseline required tests.\n* Percutaneous coronary intervention (PCI) within 30 days prior to the index procedure.","ALL","18 Years",{"count":20,"type":21},450,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31],"Mitral Regurgitation","Mitral Insufficiency","Mitral Valve Incompetence","Mitral Valve Regurgitation","Mitral Incompetence",[27,33,34,35,36,37,38],"TMVR","Functional Regurgitation","Degenerative Regurgitation","Transcatheter Mitral Valve Replacement","Primary Regurgitation","Secondary Regurgitation","RECRUITING","2026-07-31",{"date":42,"type":43},"2026-08-03","ACTUAL",{"date":45,"type":43},"2024-09-03",{"date":47,"type":21},"2031-09",{"name":49,"class":50},"4C Medical Technologies, Inc.","INDUSTRY",58]