Can a new heart pump outperform the standard during High-Risk angioplasty?
NCT ID NCT06853470
First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time
Summary
This trial tests whether a new device called SynFlow 3.0 can safely support the heart during high-risk angioplasty (a procedure to open blocked coronary arteries) as well as the standard VA-ECMO device. About 222 people with severe coronary artery disease and a weakened heart (ejection fraction ≤35%) will be randomly assigned to receive either SynFlow 3.0 or VA-ECMO during their procedure. The study will compare rates of major adverse events and other outcomes to see if SynFlow 3.0 is a viable alternative.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- SynFlow 3.0, a percutaneous left ventricular-assist device, compared with VA-ECMO circulatory support during high-risk PCI
- What this could lead to
- If SynFlow 3.0 proves as safe and effective as VA-ECMO, it could offer a less invasive option to support the heart during high-risk angioplasty, potentially improving outcomes and recovery.
- What could go wrong
- This is an early-stage trial with a limited number of patients, and the device may not perform as well as expected. There are also inherent risks of any heart-support procedure, including bleeding, infection, or device-related complications.
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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032, China
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Other studies related to the condition(s) this trial covers.
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