[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551560":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":44,"collaborators":47,"id":53,"slug":29,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":29,"eligibilityCriteria":57,"healthyVolunteers":54,"sex":58,"minAge":29,"maxAge":59,"enrollmentInfo":60,"targetDuration":29,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":72,"whyStopped":29,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Emory University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Ventrix Bio Extracellular Matrix","EXPERIMENTAL","Treatment intervention of a total of 8 injections into the right ventricle of the heart will occur before the patient comes off of the heart-lung bypass machine used during the Stage II Glenn Operation. The treatment will be conducted according to clinical guidelines set in place while the patient is undergoing a surgical intervention before the patient comes off the heart\u002Flung bypass machine required for the stage II Glenn Procedure.",[13],"Drug: Ventrix Bio Extracellular Matrix",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","VentriGel will be administered by injection into the right ventricle of the heart in the following defined doses per injection. There will be a total of 8 injections. The proposed dose of up to 0.6 mL is administered as up to 8 sequential injections of 4 injections of 0.1 mL each and 4 injections of 0.05 mL each.",[9],[20],"VentriGel",[22],{"name":23,"affiliation":5,"role":24},"William Mahle, MD","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":29,"email":30},"CONTACT","404-256-2593",null,"MahleW@kidsheart.com",[32],{"facility":33,"status":29,"city":34,"state":35,"zip":36,"country":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":29},"Children's Healthcare of Altanta","Atlanta","Georgia","30322","United States",{"type":39,"coordinates":40},"Point",[41,42],-84.38798,33.749,{"lat":42,"lon":41},{"type":24,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"William T. Mahle","Professor",[48,51],{"name":49,"class":50},"Ventrix, Inc.","INDUSTRY",{"name":52,"class":6},"University of California, San Diego","100551560",false,"NCT06461676","Study of Intramyocardial Injection of Ventrix Bio Extracellular Matrix (VentriGel) to Assess the Safety and Feasibility in Pediatric Patients with Hypoplastic Left Heart Syndrome (HLHS)","Inclusion Criteria:\n\n* Subjects with Hypoplastic Left Heart Syndrome (HLHS) requiring Stage II Glenn operation under one year of age\n\nExclusion Criteria:\n\n* Subjects undergoing the Stage II Glenn operations who do not have HLHS\n* Subjects requiring mechanical circulatory support within 5 days pre pre-surgical intervention\n* Parent or guardian unwilling or unable to comply with necessary follow-up(s)\n* Immunosuppressive diseases or subjects who require treatment with interventions that cause immunosuppression\n* A history of tumor or malignancy\n* Coagulation disorders\n* Chromosomal abnormalities that limit expected survival to \\\u003C 1 year\n* Abnormal lab values that may increase the risk of the study procedure (WBC \\>20,000 cells\u002Ful or \\\u003C 1,000 cells\u002Ful; platelet count \\\u003C 50,000 cells\u002Ful; Hgb \\\u003C 8.0 gm\u002Fdl; LFTs \\> 2x reference lab upper limit of normal) at the time of screening\n* Subjects with conduction abnormalities, including atrioventricular block and bundle branch blocks\n* Ventricular arrhythmias due to antiarrhythmic pharmacological therapy","ALL","1 Year",{"count":61,"type":62},12,"ESTIMATED","INTERVENTIONAL",[65],"PHASE1","The goal of this Phase I Open-Label study is to demonstrate the safety and feasibility of VentriGel injection in children with Hypoplastic Left Heart Syndrome (HLHS).\n\nThe main questions it aims to answer are:\n\n* Whether VentriGel is safe in treating patients with HLHS\n* Whether there are any preliminary improvements in measures of cardiac function following Ventrigel injection",[68],"Hypoplastic Left Heart Syndrome",[70,71],"Stage II Glenn operation","HLHS","NOT_YET_RECRUITING","2025-03-06",{"date":75,"type":76},"2025-03-10","ACTUAL",{"date":78,"type":62},"2025-08",{"date":80,"type":62},"2028-09",{"name":5,"class":6},1]