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Corheart 6 LVAS Study

RecruitingNAAges 18 Years - 75 YearsAllShenzhen Core Medical Technology CO.,LTD.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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. * 3\. Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia type II. * 4\. Platelet count \< 100,000 x 10\^3/L (\< 100,000/ml). * 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. * 6\. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator. * 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: * 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. * 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. * d. History of stroke within 180 days prior to enrollment, or a history of cerebrovascular disease with symptomatic (\> 70%) carotid artery stenosis * e. Serum creatinine ≥ 265 μmol/L (3.0mg/dl) or requiring dialysis. * 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. * 12\. Uncontrollable ventricular tachyarrythmias/ ventricular fibrillation (VF). * 13\. STEMI \<2 weeks before planned implantation. * 14\. Right ventricular failure as defined by one or more of the following: * a. severe depressed RV function in echocardiography * b. TAPSE \< 1.0 cm * c. CVP/PCWP ratio \> 0.63 * 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. * 17\. History of any organ transplant. * 18\. Pre albumin \< 150 mg/L, or Albumin \< 30g/L (3 g/dL). * 19\. Any condition other than HF that could limit survival to less than 24 months. * 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.
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What it tests

  • Corheart 6 Left Ventricular Assist System
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Where

11 sites
Universitätsklinikum Graz
Graz, Austria
Universitätskliniken der MedUni Wien
Vienna, Austria
Herz-und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, Germany
Deutsches Herzzentrum der Charité
Berlin, Germany
Klinikum Links der Weser
Bremen, Germany
Universitätsklinikum Hamburg
Hamburg, Germany
Universitätsklinikums Heidelberg
Heidelberg, Germany
Herzzentrum Leipzig
Leipzig, Germany

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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