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RECRUITING
NCT07094919
NA

Corheart 6: Long-term Cohort Study

Sponsor: China National Center for Cardiovascular Diseases

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2021-12-12

Completion Date

2030-09-30

Last Updated

2025-07-31

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Corheart 6 left ventricular assist system

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

Locations (8)

Fuwai Hospital Chinese Academy of Medical Sciences

Shenzhen, Guangdong, China

the 7Th People'S Hospital of Zhengzhou

Zhengzhou, Henan, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Wuhan asia heart hospital

Wuhan, Hubei, China

Nanjing First Hospital

Nanjing, Jiangsu, China

the First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Fuwai Hospital

Beijing, China

Zhongshan Hospital Fudan University

Shanghai, China