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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Corheart 6 left ventricular assist system provides circulatory support for patients with advanced left heart failure.
Fuwai Hospital Chinese Academy of Medical Sciences
Shenzhen, Guangdong, China
RECRUITINGthe 7Th People'S Hospital of Zhengzhou
Zhengzhou, Henan, China
RECRUITINGUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGWuhan asia heart hospital
Wuhan, Hubei, China
RECRUITINGNanjing First Hospital
Nanjing, Jiangsu, China
RECRUITINGthe First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGFuwai Hospital
Beijing, China
RECRUITINGZhongshan Hospital Fudan University
Shanghai, China
RECRUITINGComposite survival rate at 6 months.
The composite survival is defined as one of the following criteria, without disabling stroke (modified Rankin Score \>3 ), device replacement due to device malfunction, or urgent heart transplant due to device malfunction: * heart transplant; * explantation for cardiac recovery; * survival with device support.
Time frame: 6 months
Composite survival rate at 24 months
Time frame: 24 months
Composite survival rate at 5 years post device implantation
Time frame: 5 years
NYHA Functional Class
Time frame: Baseline, 6 months, 24 months, and 5 years post-implantation
6-minute walk test distance
Time frame: Baseline, 6 months, 24 months, and 5 years post-implantation
EuroQol-5D
Time frame: Baseline, 6 months, 24 months, 5 years post-implantation
Adverse Events
Time frame: Up to 5-year post-implantaiton
Reoperation
Time frame: Up to 5-year post-implantation
Rehospitalization
Time frame: Up to 5-year post-implantation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.