New heart pump could replace ECMO in risky angioplasty

NCT ID NCT07622446

Ongoing Disease control Sponsor: Shanghai Dynaheart Medtech Co., Ltd. Source: ClinicalTrials.gov ↗

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

Summary

This trial tests whether a new device called OmniHeart 4.0 can safely support the heart during high-risk angioplasty, compared to the standard ECMO machine. About 254 patients will be randomly assigned to receive either the OmniHeart or ECMO. Researchers will track major heart and brain complications within 30 days to see if the new device is as effective.

What this could mean

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

Active substance: OmniHeart 4.0 percutaneous ventricular assist device
What this could lead to: If successful, this device could offer a less invasive alternative to ECMO for supporting the heart during high-risk angioplasty, potentially reducing complications.
What could go wrong: This is an early-stage, non-inferiority trial with 254 participants, so results may not apply to all patients. The device may not perform as well as ECMO, and risks include bleeding, infection, or device failure.

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.

coronary artery disorder

As listed by the trial registrant

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

HIGH RISK PCI

Contacts and locations

Locations

Shanghai Dynaheart Medtech Co., Ltd

Shanghai, China
The Second Affiliated Hospital of Harbin Medical University

Jilin City, China

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