Corheart 6: Long-term Cohort Study

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

• Composite survival rate at 6 months. [Time frame: 6 months]
• Composite survival rate at 24 months [Time frame: 24 months]

Secondary outcome measures (7)

• 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]

Eligibility criteria

Inclusion criteria

• Age ≥ 18 years.
• Subject who have undergone Corheart 6 implantation on or after October 1, 2021.
• Body Surface Area (BSA) > 1.0 m2.
• Women of childbearing potential must use agree to use a effective method of contraception for the duration of the study.
• Diagnosis of NYHA Class IV heart failure, refractory to optimal guideline-directed medical therapy (GDMT) (e.g., ACE inhibitors, β-blockers, and diuretics).
• Left Ventricular Ejection Fraction (LVEF) < 30%, with at least one of the following conditions:

• Dependence on an intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation (ECMO), or other short-term mechanical circulatory support with an inability to be weaned.
• Dependence on continuous intravenous inotropic support.
• Meets the diagnostic criteria for cardiogenic shock: blood pressure < 90/60 mmHg, cardiac index < 2.0, pulmonary capillary wedge pressure > 18 mmHg
• Subject or their legally authorized representative agrees to participate in the study and signs the informed consent form.

Exclusion criteria

• Heart failure caused by unresolved thyroid disease, hypertrophic obstructive cardiomyopathy, pericardial disease, or related conditions.
• Presence of active, uncontrolled infection confirmed through clinical symptoms and laboratory tests.
• Based on the investigator's judgment, presence of technical difficulties that would lead to unacceptable surgical risk.
• Subject is intolerant to anticoagulation or antiplatelet therapy, or cannot receive other perioperative and postoperative treatments deemed necessary by the investigator based on the patient's health condition.
• Require biventricular assist device support.
• Pregnancy.
• Presence of moderate to severe aortic regurgitation or a history of mechanical aortic valve implantation but refuse or is unable to converted to a bioprosthesis or oversewn at the time of LVAD implant.
• History of any organ transplant.
• Presence of unresolved thrombocytopenia or severe coagulopathy, such as disseminated intravascular coagulation (DIC).
• Preoperative total bilirubin (TBIL) > 3.0 mg/dL, serum creatinine (SCr) > 3.0 mg/dL, or requirement for dialysis within 48 hours prior to surgery.
• History of severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, or diagnosed primary pulmonary hypertension.
• Presence of pulmonary embolism within 3 weeks prior to enrollment.
• Pulmonary artery systolic pressure greater than 60 mmHg and meet at least one of the criteria which prove the pulmonary vessels is unresponsive to pharmacologic intervention: a. most recent pulmonary vascular resistance (PVR) ≥ 8 Woods; b. transpulmonary pressure > 20mmHg.
• History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) > 5 cm in diameter.
• Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration.
• Mental illness/disorder, irreversible cognitive dysfunction, or psychosocial issues that may prevent the patient from adhering to the study protocol and the management of the implanted left ventricular assist device, or any condition leading to brain death.
• Presence cancer or other diseases that could limit survival to less than 24 months.
• Participation in any other clinical investigation that is likely to confound study results or affect the study.
• Unforeseen circumstances that the investigator determines to be unsuitable for the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 8 centers

• Fuwai Hospital Chinese Academy of Medical Sciences — Shenzhen
• the 7Th People'S Hospital of Zhengzhou — Zhengzhou
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
• Wuhan asia heart hospital — Wuhan
• Nanjing First Hospital — Nanjing
• the First Affiliated Hospital with Nanjing Medical University — Nanjing
• Fuwai Hospital — Beijing
• Zhongshan Hospital Fudan University — Shanghai

Identifiers

NCT: NCT07094919 · 2025-ZX036

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗