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

NCT02652676 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2023-02-10

No results posted yet for this study

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.

Conditions

  • Acute on Chronic Systolic Congestive Heart Failure

Interventions

PROCEDURE

Reversible Pulmonary Artery Banding

A sternotomy incision is used for application of the rPAB. Tightening is under echocardiographic control until the inter-ventricular septum becomes a midline structure. Myocardial function is augmented with inotropic and vasodilator agents that are weaned after 2-4 weeks. The infant is separated from mechanical ventilation within the first week, and enteric feeding is resumed. The infant is discharged on oral medications, with follow-ups. Band enlargement is in stages as a balloon catheter-based procedure if a finding of increasing right ventricular dilation, onset or worsening tricuspid valve regurgitation, or a gradual late increase in plasma B-type natriuretic peptide (BNP) levels, opting for a mild residual right ventricle-main pulmonary artery pressure gradient of 15-30 mmHg.

PROCEDURE

GORE-TEX DualMesh EMERGE PLUS Biomaterial

The study is being conducted to evaluate the procedure, not the materials being used. The study uses the patch as materials to create the band around the pulmonary artery which is currently done routinely off label. The patch is approved as a cardiovascular patch. FDA 501(k) K032168.

Sponsors & Collaborators

  • Loma Linda University

    lead OTHER

Principal Investigators

  • Timothy Martens, MD, PhD · Loma Linda University Medical Center

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2021-05-07
Completion
2021-05-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02652676 on ClinicalTrials.gov