Comparing a new heart support device to ECMO in high-risk heart patients

A Prospective, Multicenter, Randomized, Non-Inferiority Trial Investigating the Safety and Efficacy of the SynFlow3.0 Percutaneous Transvalvular Ventricular Assist System in Patients Undergoing High-Risk PCI (PERSIST Ⅲ Study)

This study is testing a new heart support device called SynFlow 3.0 to see if it works as well or better than the standard ECMO machine for patients with severe heart issues during high-risk surgeries.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: ForQaly Medical (Shanghai) Co., Ltd (industry)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06853470 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of the SynFlow 3.0 assist system compared to ECMO, a standard heart and lung support machine, in patients undergoing high-risk heart surgeries. The primary aim is to determine if SynFlow 3.0 can provide similar or superior support during these procedures. Researchers will assess safety, efficacy, and cost-effectiveness, focusing on patients with severe coronary artery disease who require coronary revascularization. The study is designed as a multicenter, randomized, non-inferiority trial to ensure robust results.

Who should consider this trial

Good fit: Ideal candidates include patients with severe coronary artery disease requiring coronary revascularization who are at high risk for CABG.

Not a fit: Patients who are not undergoing high-risk heart surgeries or have a higher ejection fraction than 35% may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more cost-effective alternative to ECMO for patients undergoing high-risk heart surgeries.

How similar studies have performed: Other studies have explored similar heart support devices, but the specific comparison of SynFlow 3.0 to ECMO is a novel approach.

Eligibility criteria

Inclusion Criteria:

1. The investigator assesses that the subject requires coronary revascularization, but CABG is considered high-risk or the subject refuses CABG. The investigator believes 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. Single-vessel disease with an open lesion (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 significant stenosis (≥ 70%) in at least one segment of all three major epicardial coronary artery territories: the left anterior descending artery (LAD) and/or its branches, the left circumflex artery (LCX) and/or its branches, and the right coronary artery (RCA) and/or its branches. In a left-dominant coronary system, lesions in the proximal segments of the LAD and LCX are also considered three-vessel disease.
4. The subject understands the purpose of the trial, is able to provide informed consent, is likely to be compliant after discharge, and is willing to participate in clinical follow-up.

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: systemic hypotension \[systolic blood pressure \<90 mmHg or requiring inotropes/vasopressors to maintain systolic blood pressure \>90 mmHg\] and any of the following: ongoing need for inotropes/vasopressors before entering the catheterization lab, any clinical evidence of end-organ hypoperfusion, or use of IABP or other circulatory assist 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, severe peripheral vascular disease with stents, tortuosity, or dissections that impede device placement, aortic dissection, aneurysm, or severe aortic root/arch abnormalities, hemolytic blood disorders, 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 \>3 times the upper limit of normal.
10. Renal dysfunction: subject on dialysis or serum creatinine ≥4 mg/dL (353.6 µmol/L).
11. Severe right heart failure or severe tricuspid regurgitation.
12. Women who are pregnant, breastfeeding, or 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.

Where this trial is running

Shanghai, Shanghai

• Zhongshan Hospital Affiliated to Fudan University — Shanghai, Shanghai, China (RECRUITING)

Study contacts

• Principal investigator: Jianan Wang, Phd — Second Affiliated Hospital, School of Medicine, Zhejiang University
• Study coordinator: Junbo Ge, Phd

Conditions: High Risk PCI, Coronary Arterial Disease