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)

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06461676
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Hypoplastic Left Heart Syndrome

Eligibility Criteria

Sex
ALL
Age
N/A - 1 Year
Healthy Volunteers
Not accepted

Interventions

  • Ventrix Bio Extracellular Matrix — 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.

Study Details

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 Dates

Start date
Aug 31, 2025
Status verified
Mar 2025
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ventrix Bio Extracellular Matrix
    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/lung bypass machine required for the stage II Glenn Procedure.

Primary Outcome Measure

Number of ventricular tachycardia events [ Time Frame: upto 30 days post operation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Healthcare of AltantaAtlantaGeorgia30322-

Find similar trials in Atlanta, GA

By research site
Children's Healthcare of Altanta· Atlanta, GA

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