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NCT06461676 · ClinicalTrials.gov registry record · 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)
A Phase 1 study, sponsored by Emory University.
- Not yet
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT06461676: Clinical Trial Phase 1 study, sponsored by Emory University.
NCT06461676 is a Phase 1 study that has not yet begun recruiting, run by Emory University. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06461676, a Phase 1 study, has not yet begun recruiting, sponsored by Emory University.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
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
Primary Outcome
Number of sustained/symptomatic ventricular tachycardia incidences requiring intervention with inotropic support or anti-arrhythmics
Interventions
- DRUG Ventrix Bio Extracellular Matrix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2025-08 |
| Est. Completion | 2028-09 |
| Phase | Phase 1 |
What is known before NCT06461676 opens enrollment
NCT06461676 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Ventrix Bio Extracellular Matrix is the first listed.
NCT06461676 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06461676 about?
NCT06461676 is a clinical study titled "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)". 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 prelim...
What is the current status of trial NCT06461676?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2025-08. Estimated completion is 2028-09.
What interventions are being tested in trial NCT06461676?
The interventions under investigation include: Ventrix Bio Extracellular Matrix (DRUG).
Who is sponsoring clinical trial NCT06461676?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06461676's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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