A (M)Ulti-center, Prospective, (O)Pen Label, Uncontrolled Feasibility (S)Tudy to Assess the Safety and Effectiveness of an Automatic Low Flow (A)Scites (Alfa) Pump (I)n Patients With (C)Irrhosis and Refractory or Recurrent Ascites

Inclusion Criteria:

1. patients ≥ 21 years of age

2. recurrence of grade 3 ascites requiring paracentesis for symptom relief more
frequently than once per month for a minimum of 2 of the prior 3 months

3. cirrhosis of any etiology

4. failure to respond to or intolerance to high dose diuretics

5. expected survival of greater than 3 months (MELD score ≤ 21)

6. screened for varices and on optimal management

7. diagnostic paracentesis with neutrophil count < 250 / µl within 24 hours of
implantation

8. written informed consent

9. ability to comply with study procedures and ability to operate the device

10. women of childbearing potential should use adequate contraception

Exclusion Criteria:

1. more than 2 systemic or local infections, such as peritonitis, urinary tract
infection, or abdominal skin infection within the last 6 months

2. presence of any current cancer

3. evidence of extensive ascites loculation

4. serum creatinine > 1.5 mg/dl

5. serum bilirubin > 5 mg/dl

6. eGFR < 30 ml/min/1.73m2 by MDRD (Modification of Diet in Renal Disease) method

7. gastrointestinal hemorrhage due to portal hypertension in the 2 weeks prior to
inclusion in the study

8. hepatic encephalopathy > stage II in the two weeks prior to implant

9. presence of a patent TIPS or surgical portosystemic shunt

10. presence of Budd-Chiari syndrome

11. previous solid organ transplant

12. obstructive uropathy (bladder residual volume > 100ml (determined by catheterization
or abdominal ultrasound) or any bladder anomaly which may contraindicate implantation
of the alfapump, including recurrent urinary tract infections, vesicoureteral reflux,
or history of urinary calculi)

13. International Prostate Symptom Score (I-PSS) ≥20

14. thrombocytopenia < 45,000 X106/l

15. patient undergoing therapeutic anticoagulation

16. recent (<4 months) intra-abdominal foreign body or abdominal surgery, diaphragmatic
hernia, abdominal surgery, severe abdominal adhesions, surgically irreparable hernia,
abdominal wall or skin infection, or severe malnutrition.

17. history (>6 months) of diaphragmatic hernia, history of bladder cancer, inflammatory
or ischemic bowel disease, and frequent episodes of diverticulitis.

18. any non-liver disease with life expectancy < 1 year

19. patients eligible for TIPS (unless they have refused TIPS placement).

20. presence of any active implantable or body-worn devices that cannot be removed

21. pregnancy

22. patients being in another therapeutic clinical study