New heart pump could replace ECMO in risky angioplasty

NCT ID NCT07622446

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

Contacts and locations

Locations

  • Shanghai Dynaheart Medtech Co., Ltd

    Shanghai, China

  • The Second Affiliated Hospital of Harbin Medical University

    Jilin City, China