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NCT07622446
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).
Conditions: High-risk PCI
Sex: All
Ages: 18 Years – 90 Years
Healthy volunteers: No
Phase: NA
Enrollment: 254
Sponsor: Shanghai Dynaheart Medtech Co., Ltd.
Location: The Second Affiliated Hospital of Harbin Medical University Jilin
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.
Eligibility Criteria
Inclusion Criteria:
\- 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.
3\. The patient meets one of the following conditions:
1. The left ventricular ejection fraction (LVEF) is \= 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.
4\. 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.
Exclusion Criteria:
* 1\. Acute ST-segment elevation myocardial infarction within 24 hours before enrollment.
2\. Cardiac arrest occurred within 24 hours before enrollment and cardiopulmonary resuscitation was required.
3\. 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).
5\. 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.
7\. 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.
9\. Aortic lesions (including aortic aneurysms, aortic dissections, extreme tortuosity or calcification) that interfere with the operation.
10\. Chronic renal insufficiency (serum creatinine \>= 4 mg/dl), or dialysis treatment is required.
11\. Liver insufficiency (liver transaminase and bilirubin levels are more than 3 times the upper limit of the normal range).
12\. Uncorrected abnormal coagulation function (platelet count \= 2.0 or fibrinogen \
Source: ClinicalTrials.gov (NCT07622446). StuddyBuddy aggregates publicly available trial information.
