NCT05353816

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Shenzhen Core Medical Technology CO.,LTD. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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. Following the initial 3-month follow-up, the study was extended to assess the primary endpoint of event-free survival at 24 months, with further follow-up to 5 years to evaluate long-term outcomes. The primary endpoint include the success rate of device implantation at 3 months and event-free survival at 24 months post-implantation. All adverse events will be adjudicated by an independent Clinical Events Committee (CEC).

Conditions

• End-stage Heart Failure

Interventions

Type	Name	Description
DEVICE	Corheart 6 Left Ventricular Assist System	Implantation of the Corheart 6 Left Ventricular Assist Device for mechanical circulatory support.

Timeline

• Start date: 2022-01-26
• Primary completion: 2024-09-30
• Completion: 2027-10-01
• First posted: 2022-04-29
• Last updated: 2026-02-02

Locations

11 sites across 1 country: China