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

NCT02652676 | Terminated

• 1 other identifier: 5150418
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Infant Cardiac Transplantation; End-stage Idiopathic Dilated Cardiomyopathy; Mechanical Circulatory Device; End Stage Dilated Left Ventriculopathy; Acute-on-Chronic Left Ventricular Failure

Outcome Measures

Primary Outcomes (1)

• Surgical Success

  positive surgical outcome, the survival of the patient, the lack of a need for mechanical circulatory support or heart transplant, and improved left ventricular function

  5 years

Secondary Outcomes (2)

• All Cause Mortality

  5 years

• Persistent Heart Failure

  5 years

Study Arms (1)

Reversible Pulmonary Artery Banding Procedure

EXPERIMENTAL

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.

Procedure: Reversible Pulmonary Artery Banding; Procedure: GORE-TEX DualMesh EMERGE PLUS Biomaterial

Interventions

Reversible Pulmonary Artery Banding PROCEDURE

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.

Also known as: rPAB

Reversible Pulmonary Artery Banding Procedure

GORE-TEX DualMesh EMERGE PLUS Biomaterial PROCEDURE

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.

Also known as: Gortex Cardiovascular Patch

Reversible Pulmonary Artery Banding Procedure

Eligibility Criteria

• Age: Up to 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Children's Hospital

Loma Linda, California, 92354, United States

Location

Related Publications (9)

• Arbustini E, Weidemann F, Hall JL. Left ventricular noncompaction: a distinct cardiomyopathy or a trait shared by different cardiac diseases? J Am Coll Cardiol. 2014 Oct 28;64(17):1840-50. doi: 10.1016/j.jacc.2014.08.030. Epub 2014 Oct 21.

  PMID: 25443708 BACKGROUND

• Bailey LL. Back to the future! Bold new indication for pulmonary artery banding. J Heart Lung Transplant. 2013 May;32(5):482-3. doi: 10.1016/j.healun.2013.03.001. No abstract available.

  PMID: 23570740 BACKGROUND

• Brancaccio G, Amodeo A, Ricci Z, Morelli S, Gagliardi MG, Iacobelli R, Michielon G, Picardo S, Parisi F, Pongiglione G, Di Donato RM. Mechanical assist device as a bridge to heart transplantation in children less than 10 kilograms. Ann Thorac Surg. 2010 Jul;90(1):58-62. doi: 10.1016/j.athoracsur.2010.03.056.

  PMID: 20609748 BACKGROUND

• Everett BM, Berger JS, Manson JE, Ridker PM, Cook NR. B-type natriuretic peptides improve cardiovascular disease risk prediction in a cohort of women. J Am Coll Cardiol. 2014 Oct 28;64(17):1789-97. doi: 10.1016/j.jacc.2014.04.089. Epub 2014 Oct 21.

  PMID: 25443700 BACKGROUND

• Julious SA. Two-sided confidence intervals for the single proportion: comparison of seven methods by Robert G. Newcombe, Statistics in Medicine 1998; 17:857-872. Stat Med. 2005 Nov 15;24(21):3383-4. doi: 10.1002/sim.2164. No abstract available.

  PMID: 16206245 BACKGROUND

• Miyamoto SD, Karimpour-Fard A, Peterson V, Auerbach SR, Stenmark KR, Stauffer BL, Sucharov CC. Circulating microRNA as a biomarker for recovery in pediatric dilated cardiomyopathy. J Heart Lung Transplant. 2015 May;34(5):724-33. doi: 10.1016/j.healun.2015.01.979. Epub 2015 Jan 30.

  PMID: 25840506 BACKGROUND

• Ross RD. The Ross classification for heart failure in children after 25 years: a review and an age-stratified revision. Pediatr Cardiol. 2012 Dec;33(8):1295-300. doi: 10.1007/s00246-012-0306-8. Epub 2012 Apr 5.

  PMID: 22476605 BACKGROUND

• Schranz D, Veldman A, Bartram U, Michel-Behnke I, Bauer J, Akinturk H. Pulmonary artery banding for idiopathic dilative cardiomyopathy: a novel therapeutic strategy using an old surgical procedure. J Thorac Cardiovasc Surg. 2007 Sep;134(3):796-7. doi: 10.1016/j.jtcvs.2007.04.044. No abstract available.

  PMID: 17723838 BACKGROUND

• Schranz D, Rupp S, Muller M, Schmidt D, Bauer A, Valeske K, Michel-Behnke I, Jux C, Apitz C, Thul J, Hsu D, Akinturk H. Pulmonary artery banding in infants and young children with left ventricular dilated cardiomyopathy: a novel therapeutic strategy before heart transplantation. J Heart Lung Transplant. 2013 May;32(5):475-81. doi: 10.1016/j.healun.2013.01.988. Epub 2013 Feb 12.

  PMID: 23410738 BACKGROUND

MeSH Terms

Interventions

Biocompatible Materials

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Timothy Martens, MD, PhD

  Loma Linda University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: January 12, 2016
• Study Start: January 1, 2016
• Primary Completion: May 7, 2021
• Study Completion: May 7, 2021
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

US (1)