[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07503236":3,"trial-entities:NCT07503236":106,"trial-summary:NCT07503236":110},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":33,"secondary_outcomes":38,"sex":39,"minimum_age":40,"maximum_age":41,"healthy_volunteers":42,"eligibility_criteria":43,"std_ages":68,"locations":71,"central_contacts":97,"overall_officials":103,"references":104,"see_also_links":105},"NCT07503236","CIP-002","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","RECRUITING","2032-12","2026-07","2026-07-28","2026-07-02","Nyra Medical, Inc.","INDUSTRY",true,"Safety and performance evaluation of the CARLEN System in patients with functional mitral valve regurgitation.","The purpose of this early feasibility study (EFS) is to evaluate the safety and performance of the CARLEN System in patients with symptomatic, moderate-to-severe or severe (MR ≥ 3+), functional (or secondary) mitral regurgitation.",[19],"Mitral Regurgitation Functional",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},30,"ESTIMATED",[29],{"type":30,"name":31,"description":31,"armGroupLabels":32},"DEVICE","CARLEN System",[31],[34],{"measure":35,"description":36,"timeFrame":37},"Primary Endpoint","Freedom from device- or procedure-related serious adverse events through 30-days post-procedure","30-days post-procedure",[],"ALL","21 Years",null,false,{"inclusion":44,"exclusion":50,"raw_text":67},[45,46,47,48,49],"Age \\> 21 years at time of enrollment","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","Moderate-to-severe or severe (MR ≥ 3+) functional (secondary) mitral valve regurgitation","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","Patient is suitable for transcatheter mitral valve repair as determined by the local multidisciplinary Heart Team and confirmed by the Eligibility Committee",[51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66],"Estimated life expectancy of less than 12 months","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","Left Ventricular Ejection Fraction (LVEF) \\\u003C 20%","Left ventricular end diastolic diameter (LVEDD) \\> 75 mm","Acute hemodynamic decompensation","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","Contraindicated for transesophageal echo (TEE)","Presence of other anatomical characteristics and\u002For significant comorbidities that in the judgement of the Investigator or Eligibility Committee precludes the subject from participation","Aortic valve disease requiring intervention or intervention","Severe or greater tricuspid regurgitation","Severe right ventricular dysfunction","Severe pulmonary hypertension","Presence of significant congenital heart disease","Planned or scheduled cardiac surgery within next 12 months","Endocarditis within last 90 days","Evidence of intracardiac mass, vegetation, or inflammatory or infectious valve disease","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",[69,70],"ADULT","OLDER_ADULT",[72,81,89],{"facility":73,"status":8,"city":74,"state":75,"zip":76,"country":77,"geoPoint":78},"University of California, Davis","Sacramento","California","95616","United States",{"lat":79,"lon":80},38.58157,-121.4944,{"facility":82,"status":8,"city":83,"state":84,"zip":85,"country":77,"geoPoint":86},"University of Michigan","Ann Arbor","Michigan","48109",{"lat":87,"lon":88},42.27756,-83.74088,{"facility":90,"status":8,"city":91,"state":92,"zip":93,"country":77,"geoPoint":94},"The Christ Hospital","Cincinnati","Ohio","45219",{"lat":95,"lon":96},39.12711,-84.51439,[98],{"name":99,"role":100,"phone":101,"email":102},"Jennifer Mischke, VP of Regulatory and Clinical","CONTACT","888 397 8046","jmischke@nyra-medical.com",[],[],[],{"nct_id":4,"conditions":107,"biomarkers":109},[108],"Mitral Valve Insufficiency",[],{"nct_id":4,"found":15,"summary":111,"prompt_version":121},{"design":112,"status":113,"heading":114,"summary":115,"follow_up":116,"word_count":117,"commitments":118,"compensation":119,"drugs_mentioned":120},"This is an early feasibility study, meaning it's one of the first times this device is being tested in people. It plans to include 30 participants.","completed","Early Feasibility Study of the Nyra Cardiac Leaflet Enhancer (CARLEN) System for Mitral Regurgitation","This study is testing the safety and performance of a new device called the CARLEN System. It's for people who have moderate-to-severe or severe functional mitral regurgitation (a condition where a heart valve doesn't close properly, causing blood to leak backward). You might be able to join if you are over 21, have symptoms from your mitral regurgitation, and are willing to participate in all study visits. The researchers will look at how safe and well the CARLEN System works for 30 days after the procedure. The study plans to enroll 30 participants, but its current recruitment status is unclear.","Your safety and performance will be evaluated for 30 days after the procedure.",100,"You would need to provide informed consent, be willing to participate in all testing, and agree to return for all required follow-up visits after the procedure.","Not stated in the trial record.",[31],"v2"]