Reversible Pulmonary Artery Banding as Simplified Management of End-stage Dilated Left Ventriculopathy in Early Life
Acute on Chronic Systolic Congestive Heart Failure
About this trial
This is an interventional other trial for Acute on Chronic Systolic Congestive Heart Failure focused on measuring Infant Cardiac Transplantation, End-stage Idiopathic Dilated Cardiomyopathy, Mechanical Circulatory Device, End Stage Dilated Left Ventriculopathy, Acute-on-Chronic Left Ventricular Failure
Eligibility Criteria
Inclusion Criteria:
- Age 0-4 years
- Isolated, idiopathic left-ventricular end-stage dilated cardiomyopathy or a Left Ventricular End-Diastolic Diameter (LVEDD) Z-score > 4.5; Ejection Fraction (EF) < 30%
- Acceptable candidate for mechanical circulatory support and/or cardiac transplantation
- Preserved right-ventricular function
- Clinical functional status IV (hospitalized)
- Parental consent
Exclusion Criteria:
- Biventricular end-stage dilated cardiomyopathy
- Proven or suspected myocarditis
- Concomitant structural (congenital) heart disease
- Moderate-severe tricuspid valve regurgitation
- Pulmonary hypertension out of proportion with left-ventricular end-stage cardiomyopathy
- Hereditary disease associated with bi-ventricular dysfunction
- Age greater than 4 years
- No parental consent
Sites / Locations
- Loma Linda University Children's Hospital
Arms of the Study
Arm 1
Experimental
Reversible Pulmonary Artery Banding Procedure
The addition of afterload Reversible Pulmonary Artery Banding to a normal-functioning right ventricle (in the setting of end-stage dilated cardiomyopathy) shifts the inter-ventricular septum toward the midline, thus significantly improving left ventricular geometry and function. It permits the infant or young child to operate from a much improved position on Starling's curve with gradual resolution of congestive heart failure and the potential for lethal ventricular dysrhythmia. An abundance of progenitor myocytes known to exist within the myocardium of this patient age group may then contribute to "permanent" left ventricular restoration.