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

NCT07675005 | Not Yet Recruiting

• 1 other identifier: VentriCure
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

VentriCure

EXPERIMENTAL

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

ECMO

ACTIVE COMPARATOR

Subjects with coronary artery disease receiving high-risk PCI will be supported by the Extracorporeal Membrane Oxygenation System during the procedure.

Device: ECMO

Interventions

ECMO DEVICE

Subjects with coronary artery disease receiving high-risk PCI will be supported by the Extracorporeal Membrane Oxygenation System during the procedure.

ECMO

VentriCure Interventional left ventricular assist system DEVICE

The VentriCure interventional left ventricular assist system provides hemodynamics support for intraoperative protection during high-risk percutaneous coronary intervention.

VentriCure

Eligibility Criteria

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

You may qualify if:

• Patient age ≥18 years old;
• 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;
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Life Shield Medical Technology Co., LTD: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

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

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 30, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: June 30, 2026

Record last verified: 2026-06