Percutaneously Delivered Automated Continual Fluid Removal System in Patients With Advanced Diuretic-Resistant Heart Failure

Inclusion Criteria:

• ≥ 21 years of age

• Life expectancy > 6 months

• Heart Failure, New York Heart Association (NYHA) class II-IV

• > 1 HF related admissions in the last 12 months

• Fluid congestion (2 signs of pitting oedema, jugular distention, BW elevation,nocturnal dyspnoea score, respiration rate, pulmonary congestion and/or pleuraleffusion per chest x-ray, ascites)

• Failure to achieve effective diuresis and congestion relief despite appropriate orescalating diuretic doses or combination of diuretics

• Able to give written informed consent

• Ability to comply with study procedures and ability to operate the device themselvesor by a regular caregiver support

• Residence in proximity to the medical center to ensure easy access for requiredhospital visits and to enable home visits

• Women of childbearing potential should use adequate contraception for as long as thedevice is implanted

Exclusion Criteria:

• Any non-cardiac disease with life expectancy < 1 year

• Any patient listed for solid organ transplantation

• Patients with a history, or with an indication for mechanical circulatory support

• intravenous (IV) inotropes required in last 3 months (INTERMACS Score

• 3), excluding Levosimendan

• Immunocompromised (e.g. chronic steroid treatment, Human immunodeficiency virus (HIV), etc.)

• Insulin dependent diabetes with evidence of infection

• Severe hyponatremia as defined by a serum Sodium < 120 mmol/l

• Serum Albumin < 2.5 g/Dl

• Glomerular filtration rate (eGFR) < 20 ml/min/1.73m2 by MDRD method, using MDRD 4-variable equation that includes age, sex, ethnicity, and serum creatinine

• Previous significant intraabdominal surgery, severe abdominal adhesions,intra-abdominal foreign body (except for small inguinal mesh)

• Current or historical (within last 6 months) large diaphragmatic hernia, orsurgically irreparable, complex or recurring hernia

• 6 minutes walk test of less than 100 meters in all repeated testing (if applicable),or similar test

• Severe, multiple repeated cardiac-related ascites, subject to principal investigator (PI) discretion

• Inflammatory or ischemic bowel disease (i.e., Crohn's disease, ulcerative colitis)and frequent episodes of diverticulitis

• Current gastrointestinal active infection in the body (such as Clostridium difficileinfection)

• Gastrointestinal haemorrhage within the last 4 months

• Bacterial peritonitis episode within the last 24 months

• > 2 systemic or local infections, such as urinary tract infection or abdominal skininfection within the last 6 months

• Class B or C liver cirrhosis of non-cardiac aetiology

• 18.5 > body mass index (BMI) > 40 presenting a risk for surgery

• Patients with contraindications for general/local anaesthesia, sedation and

• or Percutaneous / Laparoscopic surgery

• Unsuitability for self-maintenance of the experimental home set-up

• Presence of any current cancer, subject to PI discretion

• Presence of any active implantable or body-worn devices that cannot be removedexcluding Implantable Cardioverter-Defibrillator (ICD) / pacemaker, subject to PIdiscretion

• Known hypersensitivity to Nitinol nickel/titanium alloy and brilliant blue

• Pregnancy

• Patients being in another therapeutic clinical study