A 28-week, feasibility study to investigate the safety and efficiency of the Automatic Fluid Shunt in patients with chronic congestive heart failure, ascites and diuretic resistance.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Fully implantable peritoneal catheter, bladder catheter, and pump
Sahlgrenska University Hospital
Gothenburg, Sweden
To evaluate safety of the Automated Fluid Shunt device during a 28-week follow-up and to evaluate its efficacy by measuring change in NT-proBNP from baseline to 16 weeks, in patients with chronic congestive heart failure, ascites and diuretic resistance.
Time frame: 16 and 28 weeks
To determine the effect of AFS-treatment on functional capacity (NYHA class and 6-min. walking distance) compared from baseline to 16 and 28 weeks
Time frame: 16 and 28 weeks
To determine change in LV volumes and LVEF (echocardiography) compared from baseline to 16 and 28 weeks
Time frame: 16 and 28 weeks
To determine change in ascites, hydrothorax and leg edema (based on CT evaluation) compared from baseline to 16 and 28 weeks
Time frame: 16 and 28 weeks
To determine change in renal function (GFR) compared from baseline to 16 and 28 weeks
Time frame: 16 and 28 weeks
To determine change in quality of life based on Minnesota Living with Heart Failure Questionnaire (MLHFQ) compared from baseline to 4, 12 and 28 weeks
Time frame: baseline to 4, 12 and 28 week
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