First in Human Study of the Icoms Flowmaker

Inclusion criteria

• 1- Age 18 and 80 years included.
• 2- Written inform consent.
• 3- Females of child-bearing age must agree to use adequate contraception.
• 4- Suitable neurocognitive status.
• 5- Distance between the aortic valve and the LV endocardial apex ≥ 95mm and the Left Ventricular (LV) volume \> 200 mL
• 6- Body Surface Area (BSA) ≥ 1.2 m².
• 7- LVEF ≤ 35 % and assessed Intermacs ≤ 4
• 8- Advanced heart failure patients symptomatic despite optimal medical management (OMM) based on the European Cardiology Society guidelines15 otherwise meeting standard best practice indications for implantable LVAD
• AND fulfilling at least one of the following criteria approved by the International multidisciplinary expert selection committee:
• 9- Contraindication or excessively heightened risk of a conventional LVAD implant due to factors such as:
• CVP/PCWP ≤ 0.6
• anatomical or surgical factors constituting excessive
• perioperative implant risks.
• (Duly recorded in the source document during the patient Inform
• consent process)
• 10- Patient with high risk of percutaneous driveline-induced morbidity such as:
• patient with recurrent infections / severe diabetes mellitus / immunodeficiency / cachexia
• psychological factors limiting percutaneous driveline
• acceptance and / or management duly recorded in the Psychological evaluation report at screening.
• 11- Temporary ineligibility to heart transplant(active or remission of cancer / highly sensitized PRA…) Duly recorded in the source document during the patient Inform consent process.
• 12- Patient's affiliation to health care insurance, if local requirement
• 13- Patient implanted with a cardioverter defibrillator from Medtronic and Boston or patient requiring implantation of a cardiac defibrillator due to a risk of ventricular arrhythmia

Exclusion criteria

• 1-Body Mass Index (BMI) \> 40.
• 2- TAPSE ≤10 mm
• 3- Pulmonary VTI ≤ 6cm
• 4- Patients not eligible to transplant due to surgical risks
• 5- Existence of any ongoing mechanical circulatory support (MCS) other than an intra-aortic balloon pump (IABP)
• 6- History of left thoracotomy.
• 7- History of confirmed untreated abdominal or thoracic aortic aneurysm \> 5 cm.
• 8- Cardiothoracic surgery within 30 days of implant.
• 9- Acute myocardial infarction within 14 days of implant.
• 10- On ventilator support for \> 72 hours within the four days immediately prior to implant.
• 11- Pulmonary embolus within three weeks of implant.
• 12- Presence of current atrial or ventricular thrombus, confirmed by MRI, CT-SCAN or Trans-Esophageal Echocardiography.
• 13- Symptomatic cerebrovascular disease, stroke within 180 days of screening or \> 80% stenosis of carotid, vertebral or cranial vessels.
• 14- Moderate to severe aortic regurgitation, defined as \> 50% regurgitant fraction.
• 15- Moderate - Severe aortic stenosis, defined as an aortic valve area (AVA) ≤ 1.5 cm2.
• 16- Active, uncontrolled infections, history of hyperleukocytosis with Leucocytes \> 10.000/mm3, CRP 17- 10mg/l, PCT \> 0,2ng/ml, positive hemocultures \< 48 hours, positive urine cultures, positive sputum cultures, any abnormalities identified by CT scan of brain-thorax and abdomino-pelvic region.
• 17- Uncorrected thrombocytopenia or generalized coagulopathy (e.g., platelet count \< 100,000 / INR \> 2.0 in the absence of anticoagulation therapy).
• 18- Hepatic insufficiency: a total bilirubin \> 3 mg/dL within 72 hours before implant, or biopsy proven liver cirrhosis or portal hypertension.
• 19- Pulmonary vascular resistance (PVR) demonstrated to be unresponsive to pharmacological manipulation and the PVR \> 6 Wood units.
• 20- Patients with a mechanical heart valve.
• 21- Etiology of heart failure due to, or associated with, uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis, or restrictive cardiomyopathy, ventricular septal defect
• 22- History of severe Chronic Obstructive Pulmonary Disease (COPD) or severe restrictive lung disease. GOLD (Global Initiative for Chronic Obstructive Lung Disease) score \< 3.
• 23- Participation in any other study involving investigational drugs, devices, or biologics.
• 24- Severe illness, other than heart disease, which would limit survival to a maximum of 1 year.
• 25- Peripheral vascular disease with rest pain or ischemic ulcers of the extremities.
• 26- Pregnancy.
• 27- Patient unwilling or unable to comply with study requirements.
• 28- Patients unable or unwilling to sign the written informed consent.
• 29- Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator.
• 30- Intolerance to anticoagulant or antiplatelet therapies or any other peri- or postoperative therapy that the investigator may administer based upon the patient's health status.
• 31- Specific liver enzymes \[AST (SGOT) and ALT (SGPT)\] 3 times upper limit of normal within 72 hours before implant.
• 32- Patient living alone (without an accompanying person).
• 33- Rapid AF, unless nodo-hissian junction ablation is considered.
• 34- Mid-septal end-systolic LV diameter ≤ 25mm
• 35- Sequential Organ Failure Assessment Score (SOFA score \> 8)
• 36- Minor subjects, persons deprived of liberty, protected adults, or those unable to consent
• 37- Subjects who have participated in a clinical trial within 12 months
• 38- Patient implanted with an Implantable Cardioverter Defibrillator (ICD) other than Medtronic and Boston.