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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07675005

Enrollment

220

Registered

2026-06-30

Start date

2026-07-30

Completion date

2028-12-30

Last updated

2026-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

DEVICEVentriCure Interventional left ventricular assist system

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

DEVICEECMO

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of major adverse events at 30 days post-PCI	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%

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 1, 2026