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The Prospective, Multicenter, Randomized Controlled Trial of the VentriCure Interventional Left Ventricular Assist System
Sponsor: Life Shield Medical Technology Co., LTD
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.
Official title: The Prospective, Multicenter, Randomized Controlled Clinical Trials Comparing the VentriCure Left Ventricular Assist System With ECMO for Supporting High-risk PCI Procedures
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2026-07-30
Completion Date
2028-12-30
Last Updated
2026-06-30
Healthy Volunteers
No
Conditions
Interventions
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.
ECMO
Subjects with coronary artery disease receiving high-risk PCI will be supported by the Extracorporeal Membrane Oxygenation System during the procedure.