[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551560":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":45,"collaborators":48,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":29,"eligibilityCriteria":59,"healthyVolunteers":56,"sex":60,"minAge":29,"maxAge":61,"enrollmentInfo":62,"targetDuration":29,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":74,"whyStopped":29,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"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,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":29},"Children's Healthcare of Altanta","Atlanta","Georgia","30322","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-84.38798,33.749,{"lat":43,"lon":42},{"type":24,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"William T. Mahle","Professor",[49,52],{"name":50,"class":51},"Ventrix, Inc.","INDUSTRY",{"name":53,"class":6},"University of California, San Diego","100551560","phase-1-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-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":63,"type":64},12,"ESTIMATED","INTERVENTIONAL",[67],"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",[70],"Hypoplastic Left Heart Syndrome",[72,73],"Stage II Glenn operation","HLHS","NOT_YET_RECRUITING","2025-03-06",{"date":77,"type":78},"2025-03-10","ACTUAL",{"date":80,"type":64},"2025-08",{"date":82,"type":64},"2028-09",{"name":5,"class":6},1]