Clinical Research Directory

Evaluate the Effectiveness and Safety of the OmniHeart 4.0 Percutaneous Ventricular Assist Device in Providing Hemodynamic Support for Patients Undergoing High-risk Percutaneous Coronary Intervention (PCI).

The objective of this clinical trial is to understand the effectiveness and safety of the OmniHeart 4.0 percutaneous ventricular assist device produced by ShanghaiDynaheart Medical Technology Co., Ltd. in providing hemodynamic support for high-risk PCI patients. The main questions it aims to answer are: During the treatment of high-risk PCI, will the application of the OmniHeart 4.0 percutaneous ventricular assist device achieve hemodynamic support that is not inferior to that of ECMO? What medical problems will occur during or after the treatment for participants who receive the OmniHeart 4.0 percutaneous ventricular assist device during high-risk PCI treatment? The researchers will compare the OmniHeart 4.0 percutaneous ventricular assist device with ECMO (a mechanical circulatory support device) using ECMO as the control group to compare the efficacy differences between the two and thereby evaluate the effectiveness and safety of the OmniHeart 4.0 percutaneous ventricular assist device in high-risk PCI treatment. Participants will: Be randomly assigned in a 1:1 ratio according to need during high-risk PCI treatment to either the experimental group or the control group. The experimental group will receive the OmniHeart 4.0 percutaneous ventricular assist device for assistance, while the control group will receive the veno-arterial extracorporeal membrane oxygenation (VA-ECMO) device for assistance. Check-ups and follow-ups will be conducted during the device usage period, at the time of weaning from the device, before discharge, 30 days after surgery, and 90 days after surgery. The effectiveness endpoint will be evaluated by recording indicators such as the incidence of major adverse cardiovascular and cerebrovascular events (MACCE) free of death within 30 days after surgery.

Standby Cannulated ECMO for High-Risk Percutaneous Coronary Intervention

The goal of this multicenter, randomized trial is to compare standby cannulated ECMO versus prophylactic ECMO in patients undergoing high-risk percutaneous coronary intervention (PCI). The main question it aims to answer is : • If standby cannulated ECMO as compared with prophylactic ECMO will improve the outcomes in patients undergoing high-risk PCI

Use of Mechanical Left ventricuLar Unloading in Complex Higher-risk Indicated Procedures

If there is a narrowing or blockage in the coronary arteries of the heart, the cardiologist may choose to treat this blockage. This is called percutaneous coronary intervention (PCI), which involves both balloon angioplasty and the placement of a stent. PCI is a commonly performed and safe procedure. However, in your case, the procedure is more complicated than usual due to the location and nature of the narrowing, the required technique for the intervention, and the fact that your heart function is reduced. As a result, your PCI will carry a higher risk than usual. During the procedure, balloons are inflated to clear the blockage, and a stent is placed to keep the artery open. This temporarily reduces or even stops the blood and oxygen supply to a large portion of the heart. This moment presents a higher risk for complications, such as low blood pressure or cardiac arrest. As a result, the heart may not pump blood effectively throughout the body, which can lead to oxygen deprivation in other organs. To help the heart in this situation, it is possible to insert a mechanical heart pump during the procedure. This form of support is introduced via an artery in the groin into your left ventricle. The pump helps the heart function and may improve the circulation to the body's organs. On the other hand, the placement of the pump increases the chance of complications. Therefore, there are both potential benefits and risks. It is currently unclear whether PCI with the temporary pump can be performed more safely than without it. This study aims to investigate whether mechanical circulatory support, specifically with the Pulsecath iVAC2L, leads to improved outcomes for patients undergoing high-risk PCI.

Clinical Trial of Ventiflow LP Supporting High-risk Percutaneous Coronary Intervention(PCI)

The purpose of this prospective, multicenter, randomized controlled clinical trial is to evaluate the effectiveness of the transcatheter left ventricular assist system (Ventiflow LP) in providing circulatory support to patients during high-risk PCI procedures compared to veno-arterial extracorporeal membrane oxygenation (VA-ECMO).The participants will be randomly assigned to the experimental group or the control group after enrollment, and will undergo percutaneous coronary intervention(PCI) with support from Ventiflow LP or VA-ECMO respectively. All participants need to undergo a 3-month follow-up after operative.