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

Congestive Heart Failure Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00907673
• Other study ID #: 2008-CHF-001
• Status: Completed
• Phase: N/A
• First received: May 21, 2009
• Last updated: December 16, 2011
• Start date: May 2009
• Est. completion date: March 2010

Study information

• Verified date: December 2011
• Source: NovaShunt AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ascites
• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• Automatic Fluid Shunt System
Fully implantable peritoneal catheter, bladder catheter, and pump

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
NovaShunt AG

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	To determine change in LV volumes and LVEF (echocardiography) compared from baseline to 16 and 28 weeks		16 and 28 weeks	No
Secondary	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	No
Secondary	To determine change in renal function (GFR) compared from baseline to 16 and 28 weeks		16 and 28 weeks	No
Secondary	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	No