[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631634":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":17,"centralContacts":18,"locations":17,"responsibleParty":24,"collaborators":17,"id":26,"slug":27,"hasResults":28,"nctId":29,"briefTitle":30,"officialTitle":31,"acronym":32,"eligibilityCriteria":33,"healthyVolunteers":28,"sex":34,"minAge":35,"maxAge":17,"enrollmentInfo":36,"targetDuration":17,"studyType":39,"phases":40,"briefSummary":42,"conditions":43,"keywords":17,"overallStatus":45,"whyStopped":17,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":17},{"fullName":5,"class":6},"Nyra Medical, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":9,"interventionNames":11},"CARLEN System","EXPERIMENTAL",[12],"Device: CARLEN System",[14],{"type":15,"name":9,"description":9,"armGroupLabels":16,"otherNames":17},"DEVICE",[9],null,[19],{"name":20,"role":21,"phone":22,"phoneExt":17,"email":23},"Jennifer Mischke, VP of Regulatory and Clinical","CONTACT","888 397 8046","jmischke@nyra-medical.com",{"type":25,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","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":37,"type":38},30,"ESTIMATED","INTERVENTIONAL",[41],"NA","Safety and performance evaluation of the CARLEN System in patients with functional mitral valve regurgitation.",[44],"Mitral Regurgitation Functional","NOT_YET_RECRUITING","2026-04-06",{"date":48,"type":49},"2026-04-13","ACTUAL",{"date":51,"type":38},"2026-06",{"date":53,"type":38},"2032-12",{"name":5,"class":6}]