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

Ki vehet részt

• ≥ 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

Ki nem vehet részt

• Any patient listed for solid organ transplantation
• Previous significant intraabdominal surgery, severe abdominal adhesions, intra-abdominal foreign body (except for small inguinal mesh)
• 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
• Any non-cardiac disease with life expectancy < 1 year
• Immunocompromised (e.g. chronic steroid treatment, Human immunodeficiency virus (HIV), etc.)
• Insulin dependent diabetes with evidence of infection
• 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
• > 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
• Presence of any current cancer, subject to PI discretion
• Known hypersensitivity to Nitinol nickel/titanium alloy and brilliant blue
• 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
• 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
• 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
• Bacterial peritonitis episode within the last 24 months
• Unsuitability for self-maintenance of the experimental home set-up
• Presence of any active implantable or body-worn devices that cannot be removed excluding Implantable Cardioverter-Defibrillator (ICD) / pacemaker, subject to PI discretion
• Pregnancy
• Patients being in another therapeutic clinical study