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Extracellular Matrix

VentriGel for Hypoplastic Left Heart Syndrome

Phase 1
Waitlist Available
Led By William Mahle, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with Hypoplastic Left Heart Syndrome (HLHS) requiring Stage II Glenn operation under one year of age
Be younger than 18 years old
Must not have
Subjects undergoing the Stage II Glenn operations who do not have HLHS
Subjects with conduction abnormalities, including atrioventricular block and bundle branch blocks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months,12 months post operation
Awards & highlights

Summary

This trial is testing if it is safe to inject VentriGel into children with Hypoplastic Left Heart Syndrome. It wants to find out if VentriGel can be used safely and if

Who is the study for?
This trial is for pediatric patients with Hypoplastic Left Heart Syndrome (HLHS). Specific eligibility details are not provided, but typically participants must meet certain health criteria and may be excluded based on factors that could interfere with the study or their safety.
What is being tested?
The trial is testing VentriGel, an extracellular matrix product injected into the heart muscle. It's a Phase I Open-Label study to check if it's safe for children with HLHS and to see any initial improvements in heart function.
What are the potential side effects?
Since this is a Phase I trial primarily assessing safety and feasibility, specific side effects of VentriGel are not detailed here. However, potential risks may include reactions at the injection site or impacts on heart function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My child has HLHS and needs a Stage II Glenn operation before turning one.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am having the Stage II Glenn operation and do not have hypoplastic left heart syndrome.
Select...
I have a heart rhythm problem known as a conduction abnormality.
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I have heart rhythm problems from heart medication.
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I have a condition or take medication that weakens my immune system.
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I have a blood clotting disorder.
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I have had cancer before.
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My genetic tests do not show abnormalities that would shorten my life to under a year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months,12 months post operation
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months,12 months post operation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Adverse Events
Number of Cardiogenic shock events
Number of deaths
+4 more
Secondary study objectives
Change in right atrial volume indexed
Change in right ventricular Tricuspid Annular Plane Systolic Excursion (TAPSE)
Change in right ventricular ejection fraction
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ventrix Bio Extracellular MatrixExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of California, San DiegoOTHER
1,157 Previous Clinical Trials
1,571,407 Total Patients Enrolled
Emory UniversityLead Sponsor
1,679 Previous Clinical Trials
2,583,654 Total Patients Enrolled
5 Trials studying Hypoplastic Left Heart Syndrome
708 Patients Enrolled for Hypoplastic Left Heart Syndrome
Ventrix, Inc.Industry Sponsor
1 Previous Clinical Trials
15 Total Patients Enrolled
~8 spots leftby Sep 2027
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