The Automated Fluid Shunt (AFS)in Chronic Congestive Heart Failure

Study Overview
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Brief Summary
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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.

Conditions
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Congestive Heart Failure, Ascites

Intervention / Treatment
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* Device: Automatic Fluid Shunt System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female or male patients ≥ 18 years of age A clinical diagnosis of chronic congestive heart failure > 6 months At least one episode of documented ADHF during the previous 6 months NYHA functional class III-IV Circulating levels of NT-proBNP ≥ 800 ng/L. Stable, optimized therapy for heart failure for at least 4 weeks prior to enrollment Echocardiography performed within 3 months Detectable ascites by ultrasound and/or computed tomography Diuretic resistance defined as a daily dose of furosemide > 80 mg, torsemide > 40 mg or bumetanide > 2 mg Written informed consent Exclusion Criteria: Present or recurring systemic or local infection, such as peritonitis, urinary tract infection, or abdominal skin infection. Ongoing malignant disease with adverse prognosis Evidence of firmly loculated peritoneal effusion. Obstructive uropathy Severely reduced renal function (S-Creatinine 300 mol/l) or end-stage renal disease requiring dialysis Severe liver disease (ASAT and/or ALAT and/or total bilirubin three times upper limit of normal range laboratory values) Pregnancy Requirement for intravenous inotropes Acute coronary syndrome or any condition requiring emergency treatment Heart disease requiring surgical intervention during the course of the study Any other clinically significant disease that could be adversely affected by study participation judged by the Investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patient condition pre-implant<br> | Device: Automatic Fluid Shunt System<br>* Fully implantable peritoneal catheter, bladder catheter, and pump<br>* Other names: AFS System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 16 and 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 16 and 28 weeks | 
| To determine change in LV volumes and LVEF (echocardiography) compared from baseline to 16 and 28 weeks |  | 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 |  | 16 and 28 weeks | 
| To determine change in renal function (GFR) compared from baseline to 16 and 28 weeks |  | 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 |  | baseline to 4, 12 and 28 week |