None listed
Conditions
Interventions
experimental group:Percutaneous transvalvular ventricular assist system support during PCI
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-79 years, no gender limit; 2. Subjects undergoing elective high-risk PCI requiring hemodynamic support (high risk condition, complex coronary lesions, hemodynamic instability) and LVEF <= 40%; 3. Subject or his/her legal representative signed the informed consent (ICF).
Exclusion criteria
Exclusion criteria: 1. Cardiogenic shock occurred within 7 days before surgery; 2. ST-segment elevation myocardial infarction (STEMI) occurred within 7 days before surgery; 3. ECMO or other mechanical circulatory assistance within 7 days before surgery; 4. Acute attack of chronic heart failure within 3 days before surgery; 5. Treatment with inotropes or vasopressors within 3 days before surgery; 6. Cardiac arrest occurred within 24 hours before surgery, requiring cardiopulmonary resuscitation or defibrillation; 7. Sustained ventricular tachycardia; 8. Emergency PCI was needed; 9. History of aortic valve replacement or reconstruction; 10. Moderate to severe aortic regurgitation (grade >= 2 on echocardiography) or evidence of aortic sclerosis; 11. Aortic stenosis with evidence (orifice area 3.5 mg/dL within 7 days before surgery; 17. Hepatic insufficiency with liver enzyme and bilirubin levels greater than 3 times the upper limit of normal; 18. Uncorrected coagulation abnormalities, including platelet count = 2.0 or fibrinogen <= 1.5 g/l; 19. History of heparin-induced thrombocytopenia (HIT); 20. Known hemoglobin disorders such as sickle cell anemia or thalassemia; 21. Severe peripheral vascular disease; 22. Infection or suspected active systemic infection at the planned surgical puncture site on the day of the study procedure, with fever or requiring antibiotic therapy; 23. Known allergy or intolerance to heparin, contrast media, or other anticoagulant and antiplatelet drugs that may be used (e.g., aspirin, clopidogrel, etc.); 24. The subject is pregnant or lactating (women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment); or a pregnancy is expected during the study; 25. The subject who is participating in another interventional clinical study and has not met the primary endpoint; 26. In the opinion of the investigator, the subject has any other factors that are not suitable for participation in the study, including but not limited to medical, social or psychological problems, and the investigator considers that the subject's ability to give informed consent or comply with the trial procedure is limited.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemodynamic support success rate during procedure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major adverse cardiac and cerebrovascular events (MACCE);Technical success;Procedure success;Left ventricular ejection fraction(LVEF) diffrence with baseline;Exception from ventricular fibrillation or ventricular tachycardia (VT) which need defibrillation;Individual severe device related adevers events;Composite severe device related adverse events;Adverse events/ severe adverse events;Operation satisfaction rate;Device defection; | — |
Countries
China
Contacts
Public ContactGe Junbo
Outcome results
None listed