Implantable pump could drain fluid for heart failure patients

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 pleural effusion per chest x-ray, ascites) * Failure to achieve effective diuresis and congestion relief despite appropriate or escalating diuretic doses or combination of diuretics * Able to give written informed consent * Ability to comply with study procedures and ability to operate the device themselves or by a regular caregiver support * Residence in proximity to the medical center to ensure easy access for required hospital visits and to enable home visits * Women of childbearing potential should use adequate contraception for as long as the device 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, or surgically 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 difficile infection) * 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 skin infection 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 removed excluding Implantable Cardioverter-Defibrillator (ICD) / pacemaker, subject to PI discretion * Known hypersensitivity to Nitinol nickel/titanium alloy and brilliant blue * Pregnancy * Patients being in another therapeutic clinical study