Evaluate the Effectiveness and Safety of the OmniHeart 4.0 Percutaneous Ventricular Assist Device… (NCT07622446) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
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).
China254 participantsStarted 2024-12-30
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The left ventricular ejection fraction (LVEF) is \<=35%, and the vessel to be treated with interventional therapy is an unprotected left main coronary artery lesion or a lesion with only a single remaining open vessel.
. The left ventricular ejection fraction (LVEF) is \<=30%, and the vessel to be treated with interventional therapy is a three-vessel coronary artery lesion.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as 'active, not recruiting' — does that mean enrollment is already closed, and if so, are there similar trials using ventricular assist devices during high-risk PCI that I might still be eligible for?
2The OmniHeart 4.0 is a device being inserted through the skin to support the heart during the PCI procedure itself — can you walk me through exactly how that device works during my specific procedure and what risks come with placing it?
3The main thing this trial is measuring is whether patients are free from major cardiac and brain events 30 days after the procedure — based on what you know about my heart condition, how does my personal risk of those kinds of events compare to what's been seen in studies like this?
4Since this trial has no listed phase, which suggests it may be an early or exploratory study of this particular device version, what is currently known about the OmniHeart 4.0's safety record compared to other cardiac support devices already approved for high-risk PCI?
5Would you recommend I consider standard high-risk PCI without a percutaneous ventricular assist device first, or do you think the level of risk in my case is the kind where a device like this would genuinely be worth discussing as part of my care plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence of freedom from major adverse cardiac and cerebrovascular events (MACCE) at 30 days after procedure.