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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).
Sponsor: Shanghai Dynaheart Medtech Co., Ltd.
Summary
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.
Official title: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Trial to Assess the Efficacy and Safety of the OmniHeart 4.0 Percutaneous Ventricular Assist Device for Hemodynamic Support in Patients Undergoing High-risk Percutaneous Coronary Intervention (PCI).
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
254
Start Date
2024-12-30
Completion Date
2026-12-31
Last Updated
2026-06-03
Healthy Volunteers
No
Conditions
Interventions
OmniHeart 4.0 Percutaneous Ventricular Assist Device
The experimental group was treated with OmniHeart 4.0 Percutaneous Ventricular Assist Device
ECMO
The control group received ECMO treatment.
Locations (1)
The Second Affiliated Hospital of Harbin Medical University
Jilin, China