[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nyra Medical, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":40},{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100631634","early-feasibility-study-efs-of-the-nyra-cardiac-leaflet-enhancer-carlen-system-100631634",false,"NCT07503236","Early Feasibility Study (EFS) of the Nyra Cardiac Leaflet Enhancer (CARLEN) System","ENHANCE EFS: Early Feasibility Study (EFS) of the Nyra Cardiac Leaflet Enhancer (CARLEN) System","ENHANCE EFS","Key Inclusion Criteria:\n\n* Age \\> 21 years at time of enrollment\n* Patient has provided informed consent, is willing and capable of participating in all testing, and agrees to return for all required post-procedure follow-up visits\n* Moderate-to-severe or severe (MR ≥ 3+) functional (secondary) mitral valve regurgitation\n* Symptomatic with mitral regurgitation (NYHA Class II, III, or ambulatory IV) despite maximally-tolerated guideline-directed medical therapy (GDMT) as determined by the local multidisciplinary Heart Team\n* Patient is suitable for transcatheter mitral valve repair as determined by the local multidisciplinary Heart Team and confirmed by the Eligibility Committee\n\nKey Exclusion Criteria:\n\n* Estimated life expectancy of less than 12 months\n* Women who are pregnant, lactating, or planning to become pregnant during the clinical study. Women of child-bearing potential must have negative pregnancy test result within 2 weeks prior to the procedure\n* Left Ventricular Ejection Fraction (LVEF) \\\u003C 20%\n* Left ventricular end diastolic diameter (LVEDD) \\> 75 mm\n* Acute hemodynamic decompensation\n* Known hypersensitivity or contraindications to necessary and routine medications including contrast compounds or components used in the CARLEN System that cannot be successfully pre-medicated, including nitinol, an alloy of nickel and titanium\n* Contraindicated for transesophageal echo (TEE)\n* Presence of other anatomical characteristics and\u002For significant comorbidities that in the judgement of the Investigator or Eligibility Committee precludes the subject from participation\n* Aortic valve disease requiring intervention or intervention\n* Severe or greater tricuspid regurgitation\n* Severe right ventricular dysfunction\n* Severe pulmonary hypertension\n* Presence of significant congenital heart disease\n* Planned or scheduled cardiac surgery within next 12 months\n* Endocarditis within last 90 days\n* Evidence of intracardiac mass, vegetation, or inflammatory or infectious valve disease","ALL","21 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","Safety and performance evaluation of the CARLEN System in patients with functional mitral valve regurgitation.",[27],"Mitral Regurgitation Functional","NOT_YET_RECRUITING","2026-04-06",{"date":31,"type":32},"2026-04-13","ACTUAL",{"date":34,"type":21},"2026-06",{"date":36,"type":21},"2032-12",{"name":38,"class":39},"Nyra Medical, Inc.","INDUSTRY",""]