[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06461676":3,"trial-entities:NCT06461676":133,"trial-summary:NCT06461676":136},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":37,"secondary_outcomes":67,"sex":91,"minimum_age":92,"maximum_age":93,"healthy_volunteers":94,"eligibility_criteria":95,"std_ages":110,"locations":112,"central_contacts":122,"overall_officials":128,"references":131,"see_also_links":132},"NCT06461676","STUDY00006965","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)","NOT_YET_RECRUITING","2028-09","2025-03","2025-03-10","2025-08","Emory University","OTHER",true,"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","HLHS, a type of congenital heart disease, presents a unique challenge where the left ventricle fails to develop, necessitating the right ventricle to manage both systemic and pulmonary blood flow. This condition, once fatal, has become manageable due to advancements in surgical techniques, with reported 5-year survival rates of 70-90%. However, these staged procedures, while lifesaving, can strain the right ventricle, leading to long-term issues such as weakened muscle and reduced cardiac function. Additionally, even with surgical intervention, patients often face a diminished quality of life.\n\nAddressing these challenges, ongoing clinical trials explore regenerative therapies, particularly stem cell injections, aiming to improve heart function. Yet, concerns persist regarding the practicality and efficacy of these treatments, including issues with cell survival and coordination of injections within narrow timeframes.\n\nInnovatively, the investigator and the team propose an alternative approach using VentriGel, an injectable hydrogel derived from decellularized porcine myocardium. Originally designed for treating heart failure post-myocardial infarction in adults, VentriGel has shown promising results in animal models, demonstrating significant improvements in cardiac function. Notably, its shelf-stable nature and flexible timing for administration offer advantages over traditional stem cell therapies.\n\nMoreover, VentriGel's effectiveness in addressing right-ventricular failure, as demonstrated in recent studies, highlights its potential as a solution for HLHS patients. Leveraging approved extracellular matrix devices, such as Alloderm and SurgiSIS, further underscores the feasibility and safety of this approach, paving the way for potentially transformative treatments in congenital heart diseases.",[18],"Hypoplastic Left Heart Syndrome",[20,21],"Stage II Glenn operation","HLHS","INTERVENTIONAL","TREATMENT",[25],"PHASE1",{"count":27,"type":28},12,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Ventrix Bio Extracellular Matrix","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.",[32],[36],"VentriGel",[38,42,46,50,52,55,58,61,64],{"measure":39,"description":40,"timeFrame":41},"Number of ventricular tachycardia events","Number of sustained\u002Fsymptomatic ventricular tachycardia incidences requiring intervention with inotropic support or anti-arrhythmics","upto 30 days post operation",{"measure":43,"description":44,"timeFrame":45},"Number of Cardiogenic shock events","Cardiogenic shock (i.e. tissue hypoperfusion presented by hypotension due to decreased cardiac output, determined by rising lactate levels (5x normal levels in first 24 hours, 2.5x normal levels in first 30 days)","Day 1, 30 days post operation",{"measure":47,"description":48,"timeFrame":49},"Number of unplanned cardiovascular operation events","Unplanned cardiovascular operation due to right ventricular intramyocardial injection site bleeding in the first 5 days after Stage II operation decreased cardiac output, determined by rising lactate levels (5x normal levels in first 24 hours, 2.5x normal levels in first 30 days)","30 days post operation",{"measure":51,"description":51,"timeFrame":41},"Number of patients requiring new permanent pacemaker",{"measure":53,"description":54,"timeFrame":41},"Stroke or embolic event","Stroke or embolic event to the brain determined by CT scan",{"measure":56,"description":57,"timeFrame":41},"Number of Adverse Events","Number of adverse events occurring post op",{"measure":59,"description":60,"timeFrame":41},"Number of deaths","Number of deaths occurring post op",{"measure":62,"timeFrame":63},"Number of VentriGel products manufactured and delivered to subjects","12 months",{"measure":65,"timeFrame":66},"Number of patients receiving Cardiac MRIs","Baseline, 6 months, 12 months",[68,72,74,76,80,83,85,87,89],{"measure":69,"description":70,"timeFrame":71},"Change in right ventricular ejection fraction","This will be measured by serial echocardiograms and MRI scans","Baseline, 6 months, 12 months post operation",{"measure":73,"description":70,"timeFrame":71},"Change in right ventricular end diastolic volume",{"measure":75,"description":70,"timeFrame":71},"Change in right ventricular end systolic volume",{"measure":77,"description":78,"timeFrame":79},"Change in tricuspid regurgitation","This will be measured by serial echocardiograms and MRI scans. tricuspid regurgitation measured by tricuspid valve vena contracta width","Baseline, 6 months,12 months post operation",{"measure":81,"description":82,"timeFrame":79},"Change in right ventricular function Fractional Area Change","This will be measured by serial transthoracic echocardiogram (TTE)",{"measure":84,"description":82,"timeFrame":79},"Change in right ventricular global longitudinal strain",{"measure":86,"description":82,"timeFrame":79},"Change in right ventricular global circumferential strain",{"measure":88,"description":82,"timeFrame":79},"Change in right ventricular Tricuspid Annular Plane Systolic Excursion (TAPSE)",{"measure":90,"description":82,"timeFrame":79},"Change in right atrial volume indexed","ALL",null,"1 Year",false,{"inclusion":96,"exclusion":98,"raw_text":109},[97],"Subjects with Hypoplastic Left Heart Syndrome (HLHS) requiring Stage II Glenn operation under one year of age",[99,100,101,102,103,104,105,106,107,108],"Subjects undergoing the Stage II Glenn operations who do not have HLHS","Subjects requiring mechanical circulatory support within 5 days pre pre-surgical intervention","Parent or guardian unwilling or unable to comply with necessary follow-up(s)","Immunosuppressive diseases or subjects who require treatment with interventions that cause immunosuppression","A history of tumor or malignancy","Coagulation disorders","Chromosomal abnormalities that limit expected survival to \\\u003C 1 year","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","Subjects with conduction abnormalities, including atrioventricular block and bundle branch blocks","Ventricular arrhythmias due to antiarrhythmic pharmacological therapy","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",[111],"CHILD",[113],{"facility":114,"city":115,"state":116,"zip":117,"country":118,"geoPoint":119},"Children's Healthcare of Altanta","Atlanta","Georgia","30322","United States",{"lat":120,"lon":121},33.749,-84.38798,[123],{"name":124,"role":125,"phone":126,"email":127},"William Mahle, MD","CONTACT","404-256-2593","MahleW@kidsheart.com",[129],{"name":124,"affiliation":12,"role":130},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":134,"biomarkers":135},[18],[],{"nct_id":4,"found":14,"summary":137,"prompt_version":147},{"design":138,"status":139,"heading":140,"summary":141,"follow_up":142,"word_count":143,"commitments":144,"compensation":145,"drugs_mentioned":146},"This is an open-label study, meaning both you and the study team will know you are receiving VentriGel. It aims to enroll 12 participants.","completed","VentriGel for Hypoplastic Left Heart Syndrome in Infants","This study is testing a new treatment called VentriGel for infants (up to 1 year old) with Hypoplastic Left Heart Syndrome (HLHS), a serious heart condition where the left side of the heart is underdeveloped. VentriGel is a special gel made from pig heart tissue that will be injected into the right side of the heart during a planned surgery called the Stage II Glenn operation. Researchers want to see if VentriGel is safe to use in these young patients and if it can help improve their heart function. The study plans to enroll 12 infants with HLHS who need this specific surgery. The main goals are to check for serious heart-related problems like abnormal heart rhythms or heart failure shortly after the operation.","Participants will be monitored for heart-related events up to 30 days after the operation.",124,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]