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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Xianqiang Wang
• Email: qiangxianwang@163.com
• Phone: +86 13331006960

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.