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Corheart 6 Left Ventricular Assist System Prospective, Multicenter, Single-arm Clinical Evaluation Trial

End-stage Heart Failure Clinical Trial

Official title:
Corheart 6 Left Ventricular Assist System Prospective, Multicenter, Single-arm Clinical Evaluation Trial

Clinical Trial Summary

This study is to evaluate the safety and effectiveness of the Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) used for the treatment of end-stage heart failure.

Clinical Trial Description

The Corheart 6 Left Ventricular Assist System (also called "the Corheart 6 LVAS", or "the Corheart 6") is developed and manufactured by Shenzhen Core Medical Technology Co., Ltd. It is indicated for providing short-term and long-term mechanical circulatory support for patients with end-stage heart failure. This prospective, multi-center, and single-arm trial evaluates the safety and effectiveness of the device in treating patients with end-stage heart failure. 50 patients from 12 investigational sites will be enrolled for Corheart 6 VAS implantation and followed for 3 months post-implantation. The primary study endpoint is the success rate of device implantation at 3 months post-implantation. All adverse events will be adjudicated by an independent Clinical Events Committee (CEC). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05353816
Study type Interventional
Source Shenzhen Core Medical Technology CO.,LTD.
Contact
Status Completed
Phase N/A
Start date January 26, 2022
Completion date October 8, 2022
View Details
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