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

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 Overview

• Status: Completed
• Conditions: Ascites; Congestive Heart Failure
• Intervention / Treatment: Device: Automatic Fluid Shunt System

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Göteborg, Sweden, 41345
    • Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: NovaShunt AG
• Investigators: Principal Investigator: Kristjan Karason, MD, Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: May 21, 2009
• First Submitted That Met QC Criteria: May 21, 2009
• First Posted (Estimate): May 22, 2009

Study Record Updates

• Last Update Posted (Estimate): December 19, 2011
• Last Update Submitted That Met QC Criteria: December 16, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Heart Failure; Ascites
• Other Study ID Numbers: 2008-CHF-001