New Heart-Lung device could save kids with severe heart failure

NCT ID NCT06080074

Recruiting now Disease control Sponsor: Stanford University Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Aug 11, 2026 · Updated 4 times

Summary

This study tests a compact heart-lung machine called Cardiohelp in 50 children with severe heart failure. The device supports the heart for up to 30 days while kids recover or await a transplant. The trial also compares two blood thinners to see which causes fewer bleeding or clotting problems. The goal is to get the device FDA-approved for children.

What this could mean

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

Active substance: Cardiohelp device (VA-ECMO) and blood thinners (heparin or bivalirudin)
What this could lead to: If successful, this could lead to FDA approval of the Cardiohelp device for longer-term use in children with severe heart failure, and identify a safer blood thinner for these patients.
What could go wrong: This is a Phase 2 trial with only 50 children, so results are preliminary. The device is used off-label, and risks like stroke, bleeding, and organ failure are possible.

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.

cardiogenic shock cardiomyopathy congenital heart disease heart failure Shock, Cardiogenic

As listed by the trial registrant

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

CARDIOGENIC SHOCK CARDIOMYOPATHIES CONGENITAL HEART DISEASE HEART FAILURE

Contacts and locations

Locations

Children's Health Dallas
RECRUITING

Dallas, Texas, 95235, United States
Cuimc/Nyph
RECRUITING

New York, New York, 10032, United States
Duke University Hospital
RECRUITING

Durham, North Carolina, 27710, United States
Lucile Packard Children's Hospital
RECRUITING

Palo Alto, California, 94304, United States
Seattle Children's Hospital
RECRUITING

Seattle, Washington, 98105, United States

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