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Corheart 6: Long-term Cohort Study
Sponsor: China National Center for Cardiovascular Diseases
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
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