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.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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222 people
The number who actually took part.
- Started
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Sep 2024
- Finished
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Aug 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. The investigator assesses that the subject requires coronary revascularization, but CABG is considered as high-risk or the subject refuses CABG. The investigator considers the subject may benefit from PCI. 2. Left ventricular ejection fraction (LVEF) ≤ 35%. 3. Coronary angiography (CAG) or coronary computed tomography angiography (CTA) shows any of the following conditions: 1. last patent conduit (occluded vessel diameter ≥ 2.5 mm). 2. unprotected left main (LM) coronary artery disease. 3. Three-vessel disease (stenosis ≥ 70%). \*Three-vessel disease is defined as at least one significant stenosis (≥ 70%) lesion in all three major epicardial coronary artery territories: left anterior descending artery (LAD) and/or its branches, left circumflex artery (LCX) and/or its branches, and right coronary artery (RCA) and/or its branches. In the case of left coronary artery dominance, a lesion in the LAD and the proximal LCX qualified as three-vessel disease. 4. The subject is able to understand the purpose of the trial and sign the informed consent form, and is likely to be compliant to and willing to receive the clinical follow up after discharge. Exclusion Criteria: 1. STEMI within 24 hours. 2. Cardiac arrest within 24 hours. 3. Cardiogenic shock (CS) or acute decompensation of chronic heart failure (Cardiogenic shock is defined as systemic hypotension \[systolic blood pressure \<90 mmHg or requiring inotropes/vasopressors to maintain systolic blood pressure \>90 mmHg\] and any of the followings: ongoing need for inotropes/vasopressors before entering the catheterization lab, any clinical evidence of end-organ hypoperfusion, or use of IABP or other circulatory support devices). 4. History of stroke or TIA within one month prior to the procedure. 5. Contraindications to or inability to place pVAD and ECMO (including but not limited to: left ventricular thrombus, presence of a mechanical aortic valve or cardiac contractile device, moderate to severe aortic stenosis, moderate to severe aortic regurgitation, stents in peripheral access or severe peripheral vascular disease such as tortuosity and dissection which impedes device placement, aortic dissection, aortic aneurysm, or severe abnormalities of ascending aorta or aortic arch , hematological diseases causing fragility of blood cells or hemolysis , hypertrophic obstructive cardiomyopathy). 6. Presence or suspicion of active systemic infection. 7. Known contraindications to heparin (including heparin-induced thrombocytopenia), contrast agents, or study-required medications (e.g., aspirin, clopidogrel). 8. Uncorrectable coagulopathy prior to the procedure, including platelet count ≤75×10\^9\^/L or INR ≥2.0. 9. Liver dysfunction: liver enzymes and bilirubin of more than 3 times the upper limit of the normal value. 10. Renal dysfunction: undergoing dialysis or serum creatinine ≥4 mg/dL (353.6 µmol/L). 11. Severe right heart failure or severe tricuspid regurgitation. 12. Pregnant or lactating women, or women planning pregnancy during the trial. 13. Participation in another drug or medical device clinical trial without reaching the primary endpoint. 14. Other conditions deemed by the investigator as unsuitable for participation in this trial.
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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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