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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.

Study design
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.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for heart-related events up to 30 days after the operation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06461676

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
PHASE1Up to 1InterventionalTreatment
Emory University
~12 participants
Updated 2025-03-10 on ClinicalTrials.gov
What's tested:Ventrix Bio Extracellular Matrix

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of ventricular tachycardia events
Measured over upto 30 days post operation
+8 more outcomes measured

Conditions

Hypoplastic Left Heart Syndrome

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Hypoplastic Left Heart Syndrome

NCT06461676

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Children's Healthcare of Altanta

    Atlanta, Georgiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • William Mahle, MD · PRINCIPAL_INVESTIGATOR · Emory University

Who to contact

William Mahle, MD
[email protected]
404-256-2593
Email the study team

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Eligibility criteria

Inclusion

Subjects with Hypoplastic Left Heart Syndrome (HLHS) requiring Stage II Glenn operation under one year of age

Exclusion

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

What this trial measures

  • Number of ventricular tachycardia eventsupto 30 days post operation

    Number of sustained/symptomatic ventricular tachycardia incidences requiring intervention with inotropic support or anti-arrhythmics

  • Number of Cardiogenic shock eventsDay 1, 30 days post operation

    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)

  • Number of unplanned cardiovascular operation events30 days post operation

    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)

  • Number of patients requiring new permanent pacemakerupto 30 days post operation

    Number of patients requiring new permanent pacemaker

  • Stroke or embolic eventupto 30 days post operation

    Stroke or embolic event to the brain determined by CT scan

  • Number of Adverse Eventsupto 30 days post operation

    Number of adverse events occurring post op

  • Number of deathsupto 30 days post operation

    Number of deaths occurring post op

  • Number of VentriGel products manufactured and delivered to subjects12 months
  • Number of patients receiving Cardiac MRIsBaseline, 6 months, 12 months