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.

NCT Number	NCT07622446
Lead Sponsor	Shanghai Dynaheart Medtech Co., Ltd. Collaborators: The Second Affiliated Hospital of Harbin Medical University, China-Japan Union Hospital, Jilin University, Second Hospital of Jilin University, First Affiliated Hospital of Xinjiang Medical University, Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing Chao Yang Hospital, The Second Hospital of Hebei Medical University, Zibo Central Hospital, Henan Provincial Chest Hospital, Wuhan Asia Heart Hospital, First Affiliated Hospital, Sun Yat-Sen University
Conditions	High-risk PCI
Enrollment	254 participants
Start Date	2024-12-30
Primary Completion	2026-02-09 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-10