Actively Recruiting
Corheart 6: Long-term Cohort Study
Led by China National Center for Cardiovascular Diseases · Updated on 2025-07-31
160
Participants Needed
8
Research Sites
459 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Corheart 6: Long-term Cohort Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 63 18 years.
- Have undergone Corheart 6 implantation on or after October 1, 2021.
- Body Surface Area (BSA) > 1.0 m2.
- Women of childbearing potential must agree to use an effective method of contraception during the study.
- Diagnosis of NYHA Class IV heart failure, refractory to optimal guideline-directed medical therapy.
- Left Ventricular Ejection Fraction (LVEF) < 30%, with at least one of the following: dependence on intra-aortic balloon pump, ECMO, or other short-term mechanical circulatory support that cannot be weaned; dependence on continuous intravenous inotropic support; or meeting diagnostic criteria for cardiogenic shock.
- Subject or legally authorized representative agrees to participate and signs informed consent.
You will not qualify if you...
- Heart failure caused by unresolved thyroid disease, hypertrophic obstructive cardiomyopathy, pericardial disease, or related conditions.
- Active, uncontrolled infection confirmed by symptoms and lab tests.
- Technical difficulties leading to unacceptable surgical risk.
- Intolerance to anticoagulation or antiplatelet therapy, or inability to receive necessary perioperative/postoperative treatments.
- Requirement for biventricular assist device support.
- Pregnancy.
- Moderate to severe aortic regurgitation or history of mechanical aortic valve implantation without conversion to bioprosthesis at LVAD implant.
- History of any organ transplant.
- Unresolved thrombocytopenia or severe coagulopathy like disseminated intravascular coagulation.
- Preoperative total bilirubin > 3.0 mg/dL, serum creatinine > 3.0 mg/dL, or dialysis within 48 hours before surgery.
- Severe chronic obstructive pulmonary disease, restrictive lung disease, or primary pulmonary hypertension.
- Pulmonary embolism within 3 weeks prior to enrollment.
- Pulmonary artery systolic pressure > 60 mmHg with unresponsive pulmonary vessels to pharmacologic intervention.
- Confirmed untreated abdominal or thoracic aortic aneurysm > 5 cm.
- Significant peripheral vascular disease with rest pain or ulcers.
- Mental illness, irreversible cognitive dysfunction, or psychosocial issues preventing adherence or management of device.
- Cancer or other diseases limiting survival to less than 24 months.
- Participation in other clinical investigations affecting study results.
- Any other unforeseen circumstances making participation unsuitable as judged by investigator.
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Fuwai Hospital Chinese Academy of Medical Sciences
Shenzhen, Guangdong, China
Actively Recruiting
2
the 7Th People'S Hospital of Zhengzhou
Zhengzhou, Henan, China
Actively Recruiting
3
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
4
Wuhan asia heart hospital
Wuhan, Hubei, China
Actively Recruiting
5
Nanjing First Hospital
Nanjing, Jiangsu, China
Actively Recruiting
6
the First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
Actively Recruiting
7
Fuwai Hospital
Beijing, China
Actively Recruiting
8
Zhongshan Hospital Fudan University
Shanghai, China
Actively Recruiting
Research Team
X
Xianqiang Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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