Shunt vs stent: which is better for tiny hearts?

NCT ID NCT05268094

Ongoing Disease control Sponsor: Carelon Research Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two procedures used to increase blood flow to the lungs in newborns with congenital heart disease: a surgical shunt or a stent placed via catheter. About 300 babies will be randomly assigned to one method and followed for their first year. The goal is to see which approach leads to fewer serious complications or death.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Ductal arterial stent (drug-eluting stent) or systemic-to-pulmonary artery shunt (surgical procedure)
What this could lead to: If this trial succeeds, it could show which method is safer and more effective for helping newborns with certain heart defects get enough blood flow to their lungs.
What could go wrong: This is a comparative effectiveness trial, not a test of a new drug or cure. The results may not apply to all types of congenital heart disease, and both procedures carry risks like infection or blood flow problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

congenital heart disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CONGENITAL HEART DISEASE IN CHILDREN

Contacts and locations

Locations

Boston Children's Hospital

Boston, Massachusetts, 02115, United States
Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States
Children's Hospital Los Angeles

Los Angeles, California, 90027, United States
Children's Hospital of Colorado

Aurora, Colorado, 80045, United States
Children's Hospital of Philadelphia

Philadephia, Pennsylvania, 19104, United States
Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States
Children's Wisconsin

Wauwatosa, Wisconsin, 53226, United States
Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States
Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada
Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021, United States
Le Bonheur Children's Hospital

Memphis, Tennessee, 38105, United States
Levine Children's Hospital

Charlotte, North Carolina, 28203, United States
Medical University of South Carolina

Charleston, South Carolina, 29425, United States
New York Presbyterian Hospital/Columbia University Irving Medical Center

New York, New York, 10032, United States
Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States
Primary Children's Hospital

Salt Lake City, Utah, 84113, United States
Stanford Children's Health

Palo Alto, California, 94304, United States
Texas Children's Hospital

Houston, Texas, 77030, United States
UCSF Benioff Children's Hospitals

Oakland, California, 94609, United States
UT Southwestern Medical Center

Dallas, Texas, 75235, United States
University of Alabama

Birmingham, Alabama, 35233, United States
University of Michigan

Ann Arbor, Michigan, 48109, United States
University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States

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