TerminatedNot Applicable

Reversible Pulmonary Artery Banding as Simplified Management of End-stage Dilated Left Ventriculopathy in Early Life

United States4 participantsStarted 2016-01

Plain-language summary

The purpose of this study is to: 1) Remodel and restore left ventricular geometry and function. 2) Avoid the need for mechanical circulatory support (MCS) and/or cardiac transplantation (CT). 3) Confirm the outcomes of a pilot study completed in Germany and reported in The Journal of Heart and Lung Transplantation in May 2013.

Who can participate

Age range4 Years

SexALL

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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

What they're measuring

Surgical Success

Timeframe: 5 years

Trial details

NCT IDNCT02652676

SponsorLoma Linda University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05-07

View on ClinicalTrials.gov More Acute on Chronic Systolic Congestive Heart Failure trials