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)
Starting soon · Phase 1
Conditions studied: Hypoplastic Left Heart Syndrome
In brief
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). The main questions it aims to answer are: * Whether VentriGel is safe in treating patients with HLHS * Whether there are any preliminary improvements in measures of cardiac function following Ventrigel injection
Key facts
- Study ID
- NCT06461676
- Run by
- Emory University
- People needed
- 12
- Starts
- 2025-08-01
- Expected to finish
- 2028-09-01
- Last updated by the study team
- 2025-03-10
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects with Hypoplastic Left Heart Syndrome (HLHS) requiring Stage II Glenn operation under one year of age
You may not qualify if…
- 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 < 1 year
- Abnormal lab values that may increase the risk of the study procedure (WBC >20,000 cells/ul or < 1,000 cells/ul; platelet count < 50,000 cells/ul; Hgb < 8.0 gm/dl; 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
Where it is running
- Children's Healthcare of Altanta — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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