ALFApump System Versus Standard of Care in Ascites Treatment

Inclusion criteria

• Males and non-pregnant females (determined by serum pregnancy test) ≥ 18 years of age. Women of childbearing age must be prepared to use at least 1 effective (≤ 1% failure rate) method of contraception during the course of the study
• Cirrhosis of the liver defined by histological and/or clinical, and/or radiological criteria
• Presenting refractory or recurrent ascites and requiring periodic large volume paracentesis (large volume defined as > 5 L to accord with teh clinical guidance of EASL, European Association for the Study of the Liver, which recommends withdrawal of 5 L should precipitate administration of albumin).
• Capable of giving written informed consent, willing to comply with study procedures and ability to operate the device

Exclusion criteria

• Gastrointestinal haemorrhage over the last 7 days
• Renal failure defined as serum creatinine higher than or equal to 2 mg/dl
• Severe coagulopathy defined as prothrombin time greater than 40% more than upper limit of Normal (as determined locally).
• Platelet count of less than 40000 /uL unless platelet therapy is given at the time of surgery
• Clinical Evidence of recurring bacterial peritonitis, defined as 2 or more episodes over the last 6 months or a single episode within the last 2 weeks.
• Clinical evidence of recurring urinary infections, defined as 2 or more episodes over the last 6 months or a single episode within the last 2 weeks.
• Clinical evidence of loculated ascites.
• Advanced hepatocarcinoma, defined as one which exceeds Milan criteria.
• Obstructive uropathy, residual urinary volume exceeding 100 ml, or any bladder anomaly which might contraindicate implantation of the device.
• Concurrently implanted with any other Active Implantable Medical Device, including, but not limited to, cardiac pacemaker or cardioverter defibrillator.
• Pregnant females or females anticipating pregnancy during study period
• Patients currently enrolled in another interventional clinical study
• Other concomitant disease or condition likely to significantly decrease life expectancy or present anaesthetic risk (e.g., moderate to severe congestive heart failure)
• Known presence of human immunodeficiency virus (HIV)
• Immuno-modulatory treatment (including azothioprine, methotrexate, anti-TNF therapies) used within last 4 months
• Known or suspected hepatic or extra hepatic malignancy, unless adequately treated or in complete remission for ≥ 3 years
• BMI > 40 presenting a risk for surgery and tunneled lines
• Patients with contraindications for general anesthesia