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).

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.

Conditions

• High-risk PCI

Interventions

DEVICE

OmniHeart 4.0 Percutaneous Ventricular Assist Device

The experimental group was treated with OmniHeart 4.0 Percutaneous Ventricular Assist Device

DEVICE

ECMO

The control group received ECMO treatment.

Sponsors & Collaborators

• The Second Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• China-Japan Union Hospital, Jilin University

  collaborator OTHER

• Second Hospital of Jilin University

  collaborator OTHER

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• Chinese Academy of Medical Sciences, Fuwai Hospital

  collaborator OTHER

• Beijing Chao Yang Hospital

  collaborator OTHER

• The Second Hospital of Hebei Medical University

  collaborator OTHER

• Zibo Central Hospital

  collaborator OTHER_GOV

• Henan Provincial Chest Hospital

  collaborator OTHER

• Wuhan Asia Heart Hospital

  collaborator OTHER

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Shanghai Dynaheart Medtech Co., Ltd.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-30

Primary Completion

2026-02-09

Completion

2026-12-31

Countries

• China

Study Locations