Study of Mechanical Left Ventricular Support with Pulsecath iVAC2L During High-Risk Complex Coronary Procedures in Adults with Reduced Heart Function

What this Trial Is About

The trial focuses on patients undergoing high-risk percutaneous coronary intervention PCI due to complex coronary artery disease and reduced heart function. Researchers aim to study whether using a mechanical heart pump called the Pulsecath iVAC2L during PCI improves patient outcomes compared to PCI without this support. This device is designed to help the heart pump blood more effectively during the procedure, which can be risky due to temporary blockage of blood flow. Participants will be randomly assigned to receive high-risk PCI with or without the Pulsecath iVAC2L mechanical circulatory support device. The Pulsecath iVAC2L is a pulsatile pump placed in the left ventricle that ejects blood into the aorta, potentially maintaining better blood flow and vascular function compared to other devices. The study compares standard PCI without support to PCI with this device to evaluate safety and effectiveness in reducing complications. During the study, patients will be monitored for various outcomes including death, cardiogenic shock, need for kidney therapy, mechanical ventilation, and heart rhythm problems within 30 days. Researchers will also assess heart and lung pressure changes, cardiac output, blood oxygen levels, procedural success, hospital stay length, and cardiovascular events. Participants will be followed closely through hospitalization and up to 30 days after PCI to evaluate safety and clinical outcomes.

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