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| Name | Class |
|---|---|
| Ventrix, Inc. | INDUSTRY |
| University of California, San Diego | OTHER |
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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:
HLHS, a type of congenital heart disease, presents a unique challenge where the left ventricle fails to develop, necessitating the right ventricle to manage both systemic and pulmonary blood flow. This condition, once fatal, has become manageable due to advancements in surgical techniques, with reported 5-year survival rates of 70-90%. However, these staged procedures, while lifesaving, can strain the right ventricle, leading to long-term issues such as weakened muscle and reduced cardiac function. Additionally, even with surgical intervention, patients often face a diminished quality of life.
Addressing these challenges, ongoing clinical trials explore regenerative therapies, particularly stem cell injections, aiming to improve heart function. Yet, concerns persist regarding the practicality and efficacy of these treatments, including issues with cell survival and coordination of injections within narrow timeframes.
Innovatively, the investigator and the team propose an alternative approach using VentriGel, an injectable hydrogel derived from decellularized porcine myocardium. Originally designed for treating heart failure post-myocardial infarction in adults, VentriGel has shown promising results in animal models, demonstrating significant improvements in cardiac function. Notably, its shelf-stable nature and flexible timing for administration offer advantages over traditional stem cell therapies.
Moreover, VentriGel's effectiveness in addressing right-ventricular failure, as demonstrated in recent studies, highlights its potential as a solution for HLHS patients. Leveraging approved extracellular matrix devices, such as Alloderm and SurgiSIS, further underscores the feasibility and safety of this approach, paving the way for potentially transformative treatments in congenital heart diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ventrix Bio Extracellular Matrix | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of ventricular tachycardia events | Number of sustained/symptomatic ventricular tachycardia incidences requiring intervention with inotropic support or anti-arrhythmics | upto 30 days post operation |
| Number of Cardiogenic shock events | 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) | Day 1, 30 days post operation |
| Number of unplanned cardiovascular operation events | 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) | 30 days post operation |
| Number of patients requiring new permanent pacemaker | Number of patients requiring new permanent pacemaker | upto 30 days post operation |
| Stroke or embolic event | Stroke or embolic event to the brain determined by CT scan | upto 30 days post operation |
| Number of Adverse Events | Number of adverse events occurring post op | upto 30 days post operation |
| Number of deaths |
| Measure | Description | Time Frame |
|---|---|---|
| Change in right ventricular ejection fraction | This will be measured by serial echocardiograms and MRI scans | Baseline, 6 months, 12 months post operation |
| Change in right ventricular end diastolic volume |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| William Mahle, MD | Contact | 404-256-2593 | MahleW@kidsheart.com |
| Name | Affiliation | Role |
|---|---|---|
| William Mahle, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Healthcare of Altanta | Atlanta | Georgia | 30322 | United States |
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Number of deaths occurring post op
| upto 30 days post operation |
| Number of VentriGel products manufactured and delivered to subjects | 12 months |
| Number of patients receiving Cardiac MRIs | Baseline, 6 months, 12 months |
This will be measured by serial echocardiograms and MRI scans
| Baseline, 6 months, 12 months post operation |
| Change in right ventricular end systolic volume | This will be measured by serial echocardiograms and MRI scans | Baseline, 6 months, 12 months post operation |
| Change in tricuspid regurgitation | This will be measured by serial echocardiograms and MRI scans. tricuspid regurgitation measured by tricuspid valve vena contracta width | Baseline, 6 months,12 months post operation |
| Change in right ventricular function Fractional Area Change | This will be measured by serial transthoracic echocardiogram (TTE) | Baseline, 6 months,12 months post operation |
| Change in right ventricular global longitudinal strain | This will be measured by serial transthoracic echocardiogram (TTE) | Baseline, 6 months,12 months post operation |
| Change in right ventricular global circumferential strain | This will be measured by serial transthoracic echocardiogram (TTE) | Baseline, 6 months,12 months post operation |
| Change in right ventricular Tricuspid Annular Plane Systolic Excursion (TAPSE) | This will be measured by serial transthoracic echocardiogram (TTE) | Baseline, 6 months,12 months post operation |
| Change in right atrial volume indexed | This will be measured by serial transthoracic echocardiogram (TTE) | Baseline, 6 months,12 months post operation |
| ID | Term |
|---|---|
| D018636 | Hypoplastic Left Heart Syndrome |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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