Tests the Corheart 6 heart pump in people with advanced heart failure

Trial details

Who runs it

Shenzhen Core Medical Technology CO.,LTD.

Trial code

NCT05876000

Record updated

8 January 2026

Original description

The primary objective of this study is to evaluate the safety and effectiveness of the Corheart 6 LVAS when used for the treatment of advanced left ventricular heart failure in a European population at 6 months post-implantation.Read full original descriptionShow less

Prospective Multi-Center Single-Arm Study for Evaluating the Corheart 6 Left Ventricular Assist System

The primary objective of this study is to evaluate the safety and effectiveness of the Corheart 6 LVAS when used for the treatment of advanced left ventricular heart failure in a European population at 6 months post-implantation.

The secondary objective is to assess the long-term safety and effectiveness of Corheart 6 LVAS treatment.

Inclusion: 1. Age ≥ 18 years and ≤ 75 years; 2. The patient has signed an Informed Consent Form; 3. Body Surface Area (BSA) ≥ 1.2 m\^2; 4. New York Heart Association (NYHA) Class IV; 5. Left Ventricular Ejection Fraction (LVEF) ≤ 25%; 6. Despite the optimal medical management based on current guidelines, the patient must also meet one or more of the following:; a. Unable to exercise for HF,; or; if able to perform cardiopulmonary testing, with peak VO2 <12 mL/kg/min and/or < 50% predicted value; b. Progressive end-organ dysfunction (worsening renal and/or hepatic function, type II pulmonary hypertension, cardiac cachexia) due to reduced perfusion and not to inadequately low ventricular filling pressure (PCWP > 20 mmHg and SBP < 90 mmHg or CI < 2.0 L/min/m2); c. Impella or IABP assisted; d. Inotrope dependent/unable to wean from inotropes.

Exclusion: 1. Heart failure who can be treated with other therapy options (e.g. CRT, CRT-D, etc.); 2. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients' health status; 6. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator; d. History of stroke within 180 days prior to enrollment, or a history of cerebrovascular disease with symptomatic (> 70%) carotid artery stenosis; 13. STEMI <2 weeks before planned implantation; 15. Planned Bi-VAD support prior to enrollment; 16. Cardiac arrest with a history of resuscitation 1-month before inclusion, without full restoration of cognitive function; 5. Psychiatric disease/ disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and ventricular assist system management; 7. Presence of an active, uncontrolled infection; 8. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:; b. History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, or FEV1 < 50% predicted; c. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention; f. Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration; 9. Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive/ restrictive cardiomyopathy, pericardial disease, amyloidosis or giant cell myocarditis; 10. Uncorrected moderate to severe aortic insufficiency without plans for correction during pump implant; 11. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) > 5 cm in diameter; 14. Right ventricular failure as defined by one or more of the following:; 17. History of any organ transplant; 19. Any condition other than HF that could limit survival to less than 24 months; 4. Platelet count < 100,000 x 10\^3/L (< 100,000/ml); a. Total bilirubin > 51.3 μmol/L (3.0 mg/dl), ischemic hepatitis, or biopsy proven liver cirrhosis, or clinically Child-Pugh B and C score; e. Serum creatinine ≥ 265 μmol/L (3.0mg/dl) or requiring dialysis; 18. Pre albumin < 150 mg/L, or Albumin < 30g/L (3 g/dL); 3. Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia type II; 12. Uncontrollable ventricular tachyarrythmias/ ventricular fibrillation (VF); a. severe depressed RV function in echocardiography; b. TAPSE < 1.0 cm; c. CVP/PCWP ratio > 0.63; 20. Positive pregnancy test if of childbearing potential; 21. Lactating mothers; 22. Participation in any other clinical investigation that is likely to confound study results or affect the study; 23. Patients who have been placed in an institution by court order or by order of the authorities.

ClinicalTrials.gov NCT05876000