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NOT YET RECRUITING
NCT07675005
NA

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

Sponsor: Life Shield Medical Technology Co., LTD

View on ClinicalTrials.gov

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

Interventions

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.

DEVICE

ECMO

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