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).

NCT07622446 | Active Not Recruiting

• 1 other identifier: ShanghaiDynaheart
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

High-Risk PCI; OmniHeart 4.0; Hemodynamic Support

Outcome Measures

Primary Outcomes (1)

• The incidence of freedom from major adverse cardiac and cerebrovascular events (MACCE) at 30 days after procedure.

  MACCE includes: all-cause mortality, stroke/TIA, myocardial infarction, and repeat coronary revascularization.

  30 days after procedure

Secondary Outcomes (5)

• The incidence of freedom from major adverse cardiac and cerebrovascular events (MACCE) at 90 days after procedure.

  90 days after procedure

• The incidence of freedom from major adverse events (MAE) at 30 and 90 days after procedure

  30 days and 90 days after procedure

• The change in left ventricular ejection fraction (LVEF) from the baseline at 30 and 90 days after procedure

  30 days and 90 days after procedure

• The change in New York Heart Association (NYHA) functional classification from the baseline at 30 and 90 days after procedure

  30 days and 90 days after procedure

• Evaluation of device performance (only for the experimental group)

  Intraprocedure - weaning off

Other Outcomes (11)

• The incidence of all-cause death at 30 and 90 days after procedure.

  30 days and 90 days after procedure

• The incidence of stroke/transient ischemic attack (TIA) at 30 and 90 days after procedure.

  30 days and 90 days after procedure

• The incidence of myocardial infarction at 30 and 90 days after procedure.

  30 days and 90 days after procedure

Study Arms (2)

Experimental group

EXPERIMENTAL

OmniHeart 4.0 Percutaneous Ventricular Assist Device

Device: OmniHeart 4.0 Percutaneous Ventricular Assist Device

Control group

ACTIVE COMPARATOR

Extracorporeal membrane oxygenation (ECMO)

Device: ECMO

Interventions

OmniHeart 4.0 Percutaneous Ventricular Assist Device DEVICE

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

Experimental group

ECMO DEVICE

The control group received ECMO treatment.

Control group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 1. The patient's age is between 18 and 90 years old (inclusive). 2. There is at least one lesion (including primary lesions and restenosis lesions) in the native coronary artery or grafted bypass vessel, and percutaneous coronary intervention (PCI) needs to be performed under hemodynamic support.
• \. The patient meets one of the following conditions:
• 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.
• Among them, a three-vessel coronary artery lesion is defined as follows: there is at least one significant stenosis in each of the three main epicardial coronary arteries (the left anterior descending branch and/or its branches, the left circumflex branch and/or its branches, the right coronary artery and/or its branches). A significant stenosis is defined as a luminal stenosis \>= 50% (by visual inspection) or complete occlusion, and at least two vessels have a luminal stenosis \>= 70%. For left-dominant coronary arteries, the presence of \>= 50% stenosis in both the left anterior descending branch and the proximal left circumflex branch is also regarded as a three-vessel coronary artery lesion.
• \. The subject or his/her legal guardian is able to understand the purpose of the trial, voluntarily participates in the trial and signs the informed consent form, and is willing to complete the follow-up as required by the trial.

You may not qualify if:

• \. Acute ST-segment elevation myocardial infarction within 24 hours before enrollment.
• \. Cardiac arrest occurred within 24 hours before enrollment and cardiopulmonary resuscitation was required.
• \. Emergency thrombolysis was performed before enrollment. 4. Cardiogenic shock exists, and cardiogenic shock is defined as follows: (1) Cardiac index (CI) \< 2.2 L/min/m² and pulmonary capillary wedge pressure (PCWP) \> 15 mmHg; (2) Hypotensive state (systolic blood pressure \< 90 mmHg for more than 30 minutes, or systolic blood pressure maintained \>= 90 mmHg with the support of vasoactive drugs and/or circulatory assist devices), accompanied by end-organ hypoperfusion (urine output \< 30 ml/hour and heart rate \> 60 beats/minute, or cold and clammy extremities).
• \. Left ventricular mural thrombus exists. 6. After aortic valve replacement (including mechanical valves, biological valves), implantation of mechanical circulatory assist devices or cardiac contractile devices.
• \. Moderate or severe aortic stenosis, moderate or severe aortic insufficiency. 8. Severe peripheral arterial stenosis or occlusion lesions that interfere with the implantation of the test device or the control device.
• \. Aortic lesions (including aortic aneurysms, aortic dissections, extreme tortuosity or calcification) that interfere with the operation.
• \. Chronic renal insufficiency (serum creatinine \>= 4 mg/dl), or dialysis treatment is required.
• \. Liver insufficiency (liver transaminase and bilirubin levels are more than 3 times the upper limit of the normal range).
• \. Uncorrected abnormal coagulation function (platelet count \<= 75,000/mm³ or INR \>= 2.0 or fibrinogen \<= 1.5 g/L).
• \. A history of stroke or transient ischemic attack (TIA) within 1 month before enrollment.
• \. Allergic or intolerant to iodine contrast agents, heparin, aspirin, ADP receptor inhibitors, and with a history of heparin-induced thrombocytopenia (HIT) in the past.
• \. Infectious endocarditis exists or is suspected to exist, or there is a systemic active infection.
• \. Currently participating in other drug/device clinical trials and the primary endpoint has not been reached.
• \. Pregnant or lactating women, those with a fertility plan within 1 year or those who are unwilling to take effective contraceptive measures.
• \. Other situations judged by the investigator as not suitable for enrollment that are unforeseen.

Sponsors & Collaborators

• Henan Provincial Chest Hospital: collaborator
• Shanghai Dynaheart Medtech Co., Ltd.: lead
• China-Japan Union Hospital, Jilin University: collaborator
• Second Hospital of Jilin University: collaborator
• Beijing Chao Yang Hospital: collaborator
• Zibo Central Hospital: collaborator
• Wuhan Asia Heart Hospital: collaborator
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• The Second Affiliated Hospital of Harbin Medical University: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• The Second Hospital of Hebei Medical University: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator

Study Sites (2)

The Second Affiliated Hospital of Harbin Medical University

Jilin City, China

Location

Shanghai Dynaheart Medtech Co., Ltd

Shanghai, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 3, 2026
• Study Start: December 30, 2024
• Primary Completion: February 9, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)