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

Not Applicable

Completed

• Conditions: Congestive Heart Failure; Ascites
• Interventions: Device: Automatic Fluid Shunt System

• Registration Number: NCT00907673
• Lead Sponsor: NovaShunt AG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-21
• Study First Submitted QC: 2009-05-21
• Study First Posted: 2009-05-22
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-16
• Last Update Posted: 2011-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient condition pre-implant	Automatic Fluid Shunt System	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Göteborg, Sweden