Corheart 6 VAS Study
Refractory Heart Failure
About this trial
This is an interventional treatment trial for Refractory Heart Failure focused on measuring advanced heart failure; ventricular assist system;
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years and ≤ 75 years 2. BSA ≥ 1.0 m^2 3. NYHA III or IV OR ACC/AHA Stage D 4. LVEF ≤ 30% 5. Patients must also meet one or more of the following: CI ≤ 2.2 L/min/m², while on Optimal Medical and Device Management, based on current heart failure practice guidelines; OR Impella or IABP assisted patient (based on doctors' judgement); OR Inotrope dependent/unable to wean from inotropes; OR Listed for heart transplantation. Exclusion Criteria: 1. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients' health status. 2. Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia type II. 3. Platelet count < 100,000 x 10^3/L (< 100,000/ml). 4. Psychiatric disease/ disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and ventricular assist system management. 5. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator. 6. Presence of an active, uncontrolled infection. 7. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure: a. Total bilirubin > 51.3 umol/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 90 days prior to enrollment, or a history of cerebrovascular disease with significant (> 80%) carotid artery stenosis e. Serum creatinine ≥ 265umol/L (3.0mg/dl) or requiring dialysis. f. Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration. 8. Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive/ restrictive cardiomyopathy, pericardial disease, amyloidosis or giant cell myocarditis. 9. Uncorrected moderate to severe aortic insufficiency without plans for correction during pump implant. 10. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) > 5 cm in diameter. 11. Uncontrollable ventricular tachyarrythmias/ ventricular fibrillation (VF). 12. STEMI <2 weeks before planned implantation. 13. 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. PCWP/CVP <0.63 14. Planned Bi-VAD support prior to enrollment. 15. History of any organ transplant. 16. Pre albumin < 150 mg/L, or Albumin < 30g/L (3 g/dL). 17. Any condition other than HF that could limit survival to less than 24 months. 18. Positive pregnancy test if of childbearing potential. 19. Lactating mothers. 20. Participation in any other clinical investigation that is likely to confound study results or affect the study.
Sites / Locations
- Deutsches Herzzentrum der Charite
Arms of the Study
Arm 1
Experimental
Corheart 6 VAS
Corheart 6 Ventricular Assist System (Corheart 6 VAS) to be used on patients with advanced refractory heart failure.