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Recruiting Not applicable

Corheart 6 LVAS Study

NCT05876000 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2024-05-14
Last updated
2026-01-08

Condition(s) studied

Refractory Heart Failure

Investigational drug(s) / intervention(s)

Corheart 6 Left Ventricular Assist System

Corheart 6 Left Ventricular Assist System: Implantation of left ventricular assist device for mechanical circulatory support

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Composite of surivival — Up to 6 months post-implantation
    At 6 months post-implantation, composite of survival to transplant, recovery, LVAS support free of disabling stroke (Modified Rankin Score \> 3), or re-operation to replace the pump due to pump failure.

Trial sites (11)

FacilityCityRegionStatus
Universitätsklinikum Graz Graz Austria Not Yet Recruiting
Universitätskliniken der MedUni Wien Vienna Austria Recruiting
Herz-und Diabeteszentrum Nordrhein-Westfalen Bad Oeynhausen Germany Recruiting
Deutsches Herzzentrum der Charité Berlin Germany Recruiting
Klinikum Links der Weser Bremen Germany Not Yet Recruiting
Universitätsklinikum Hamburg Hamburg Germany Recruiting
Universitätsklinikums Heidelberg Heidelberg Germany Recruiting
Herzzentrum Leipzig Leipzig Germany Recruiting
Universitätsklinikum Würzburg Würzburg Germany Not Yet Recruiting
IRCCS Ospedale San Raffaele Milan Italy Not Yet Recruiting
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino Torino Italy Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05876000 on ClinicalTrials.gov ↗ ← All trials in Italy