The Prospective, Multicenter, Randomized Controlled Trial of the VentriCure Interventional Left Ventricular Assist System

The Prospective, Multicenter, Randomized Controlled Clinical Trials Comparing the VentriCure Left Ventricular Assist System With ECMO for Supporting High-risk PCI Procedures

This study aims to evaluate the safety and effectiveness of the VentriCure interventional left ventricular assist system for short-term ventricular support during high-risk percutaneous coronary intervention (HRPCI) in non-emergent, hemodynamically stable coronary artery disease patients via a prospective, multi-center, randomized controlled clinical trial.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: VentriCure Interventional left ventricular assist system; Device: ECMO

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient age ≥18 years old;
2. As assessed by the cardiac team the patient needs coronary revascularization, but CABG (Coronary Artery Bypass Grafting) is of high risk, or the patient refuses to undergo CABG;
3. The patient is meeting one of the following:

(1) Coronary Artery Disease and left ventricular ejection fraction ≤35%; (2) Coronary Artery Disease and left ventricular ejection fraction ≤40% and severe heart failure; 4. PCI was required for imaging diagnosis; 5. Patient willing and able to comply with protocol requirements and accept clinical follow-up; able to understand study purpose and sign informed consent.

Exclusion Criteria:

1. Cardiac arrest within 24 hours;
2. The implantation of an interventional left ventricular assist system was either contraindicated or not feasible;
3. ST-segment elevation myocardial infarction (STEMI) within 24 hours;
4. Chronic Kidney Disease;
5. Severe right heart failure or severe tricuspid regurgitation;
6. Presence of abnormal coagulation parameters (platelet count ≤75,000/mm^3, INR≥2.0, or fibrinogen ≤1.50g/L);
7. Moderate or higher anemia;
8. History of stroke or transient ischemic attack (TIA) within one month;
9. Allergy or intolerance to anticoagulants or contrast agent;
10. Active internal bleeding within a month;
11. Presence of uncontrolled active infection;
12. Pregnant or lactating women;
13. Patients are participating in other clinical trials;
14. Other circumstances that are determined by the investigator to be unsuitable for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VentriCure; The VentriCure interventional left ventricular assist system provides hemodynamics support for intraoperative protection during high-risk percutaneous coronary intervention.	Device: VentriCure Interventional left ventricular assist system; The VentriCure interventional left ventricular assist system provides hemodynamics support for intraoperative protection during high-risk percutaneous coronary intervention.
Active Comparator: ECMO; Subjects with coronary artery disease receiving high-risk PCI will be supported by the Extracorporeal Membrane Oxygenation System during the procedure.	Device: ECMO; Subjects with coronary artery disease receiving high-risk PCI will be supported by the Extracorporeal Membrane Oxygenation System during the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of major adverse events at 30 days post-PCI	Major adverse events were defined as follows: death, new myocardial infarction, stroke, target-vessel revascularization, major bleeding. Calculation formula: 30-day MAE rate = Number of subjects experiencing any MAE event within 30 days post-PCI ÷ Total number of subjects × 100%	30 days post-PCI

Collaborators and Investigators

• Sponsor: Life Shield Medical Technology Co., LTD

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2026
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: June 23, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: VentriCure

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No