Plain-English translation of NCT06080074 on ClinicalTrials.gov ↗ ·
Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.
This trial is testing the Cardiohelp system, a portable machine that takes over some of the work of a failing heart for children up to 30 days. Researchers want to see if this device is safe and works well enough to become the first heart-support machine officially approved by the FDA for children. The study will also compare two different blood thinners used with the device to see which one causes fewer complications.
Even though doctors have used heart-support machines in children for more than 50 years, no standalone device has ever been officially approved by the FDA for pediatric use. This means all use is currently off-label and practices vary widely between hospitals. This trial aims to gather solid scientific evidence to support the first FDA approval of a heart-support device specifically for children.
You likely qualify if…
You likely don't qualify if…
If your child qualifies, they will receive the Cardiohelp device as part of their medical care for severe heart failure. They will be randomly assigned to receive one of two blood thinners to prevent clots in the device. The medical team will monitor your child closely during the 30 days of support, tracking how well the device works, any complications like bleeding or clots, and your child's overall recovery. Researchers will collect detailed information about safety and effectiveness to help determine if this device should be approved by the FDA for future use in children.
AI-generated summary from trial data · Jun 25, 2026 · Not medical advice
United States