Long-term follow-up of the Corheart 6 left ventricular assist pump for advanced heart failure

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

This project will test whether the Corheart 6 heart pump is safe and provides durable support for adults with advanced left heart failure who received the device on or after October 2021.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: China National Center for Cardiovascular Diseases (Government)
• Locations: 8 sites (Shenzhen, Guangdong and 7 other locations)
• Trial ID: NCT07094919 on ClinicalTrials.gov

What this trial studies

This prospective long-term cohort will enroll adult patients who underwent Corheart 6 implantation on or after October 1, 2021, and follow them at scheduled visits at participating centers. Data collected will include survival status, cardiac function measures, quality of life, laboratory tests, and adverse events. The primary endpoints are composite measures of survival at 6 months and at 24 months, defined as survival with device support, bridge to transplant, or device explantation for cardiac recovery without disabling stroke (mRS > 3) or device replacement. Data will be pooled from multiple high-volume Chinese cardiovascular centers and analyzed to characterize long-term safety and clinical performance of the device.

Who should consider this trial

Good fit: Adults (≥18 years) with body surface area >1.0 m2 who underwent Corheart 6 implantation on or after October 1, 2021, have NYHA class IV heart failure refractory to guideline-directed medical therapy, LVEF <30%, and meet device support criteria such as dependence on short-term mechanical support, continuous inotropes, or cardiogenic shock.

Not a fit: Patients who do not have advanced left ventricular failure, who were not implanted with Corheart 6, who have very small body size (BSA ≤1.0 m2), or who have contraindications to long-term device support are unlikely to benefit from enrollment.

Why it matters

Potential benefit: If successful, this work could confirm that Corheart 6 provides durable circulatory support and improves survival and recovery without major device-related complications.

How similar studies have performed: Other contemporary left ventricular assist devices have demonstrated improvements in survival and quality of life in advanced heart failure, but long-term outcome data specific to the Corheart 6 are still limited.

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:

  1. 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.
  2. Dependence on continuous intravenous inotropic support.
  3. 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.

Where this trial is running

Shenzhen, Guangdong and 7 other locations

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

Study contacts

• Study coordinator: Xianqiang Wang

Conditions Heart Failure; advanced heart failure; Corheart 6