NCT07094919

Corheart 6: Long-term Cohort Study

An Cohort Study of Corheart 6 Left Ventricular Assist System for the Treatment of Patients With Advanced Left Heart Failure

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the long-term effectiveness and safety of Corheart 6 left ventricular assist system as a treatment for patients with advanced left heart failure. The patients who have received the Corheart 6 treatment since October 2021, or who are planned to received it, will be enrolled until the target sample size meets statistical requirements. Data collected will include survival status, cardiac function status, quality of life, laboratory parameters and adverse events. The primary endpoint are the composite of survival at 6 months and, separately, at 24 months, defined as survival with device support, bridge to heart transplant and device explantation due to cardiac recovery, without disabling stroke (mRS \> 3) or device replacement. Data collection will adhere to the follow-up schedule specified in the protocol.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Corheart 6 left ventricular assist system	Corheart 6 left ventricular assist system provides circulatory support for patients with advanced left heart failure.

Timeline

• Start date: 2021-12-12
• Primary completion: 2027-09-30
• Completion: 2030-09-30
• First posted: 2025-07-31
• Last updated: 2025-07-31

Locations

8 sites across 1 country: China