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Shunt vs stent: which is better for tiny hearts?

NCT ID NCT05268094

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 day to 30 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Neonates with Congenital Heart Disease (CHD) and ductal-dependent pulmonary blood flow requiring only a stable source of pulmonary blood flow as the initial palliation, for whom the clinical decision is made at the enrolling center that this is best achieved by either DAS or SPS. 2. Age ≤ 30 days at time of index procedure (DAS or SPS). Exclusion Criteria: * 1\. Any patient for whom the clinical decision at the enrolling center is that an initial intervention other than DAS or SPS is indicated (e.g., Right Ventricle-Pulmonary Artery (RV-PA) conduit, Right Ventricular Outflow Tract (RVOT) stent, primary complete anatomic repair, etc.). 2\. Pulmonary Atresia with Intact Ventricular Septum (PA/IVS) where Right Ventricle (RV) decompression is planned. 3\. Presence of MAPCAs: defined as an aortopulmonary collateral that is expected to require unifocalization. 4\. Non-confluent Pulmonary Arteries (i.e., isolated Pulmonary Artery (PA) of ductal origin). 5\. Acutely jeopardized branch Pulmonary Arteries (\>75% narrowing of proximal PA based on screening cross sectional imaging \[Computed Tomography Angiography (CTA) or cardiovascular Magnetic Resonance (cMR)\]). 6\. Bilateral Patent Ductus Arteriosis (PDA). 7. Patient who, at the time of enrollment, is deemed not to be a candidate for eventual Glenn or Complete Surgical Repair (CSR) for any reason. 8\. Birth weight \<2.0 kg. 9. Gestational age \<34 weeks at birth. 10. Patient for whom additional intervention is expected concomitant with, or prior to, DAS or SPS (e.g., atrial septostomy, aortic arch intervention, or RV outflow tract intervention) - except for branch PA arterioplasty or stent/balloon angioplasty. 11\. Major co-morbidities which, in the opinion of the investigator, would negatively alter expected 1-year survival (e.g., intracranial hemorrhage, renal failure, etc.). 12\. Specific known genetic anomaly which, in the opinion of the investigator, would be expected to significantly alter clinical course in the first year of life (e.g., Trisomy 13/18, CHARGE, VACTERL). 13\. Patient who does not plan to return to the enrolling center or another participating center for Glenn/CSR.

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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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