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

This study has been completed.
Information provided by (Responsible Party):
NovaShunt AG Identifier:
First received: May 21, 2009
Last updated: December 16, 2011
Last verified: December 2011

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.

Condition Intervention
Congestive Heart Failure
Device: Automatic Fluid Shunt System

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

Resource links provided by NLM:

Further study details as provided by NovaShunt AG:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To determine change in LV volumes and LVEF (echocardiography) compared from baseline to 16 and 28 weeks [ Time Frame: 16 and 28 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To determine change in renal function (GFR) compared from baseline to 16 and 28 weeks [ Time Frame: 16 and 28 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: May 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Patient condition pre-implant Device: Automatic Fluid Shunt System
Fully implantable peritoneal catheter, bladder catheter, and pump
Other Name: AFS System


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00907673

Sahlgrenska University Hospital
Göteborg, Sweden, 41345
Sponsors and Collaborators
NovaShunt AG
Principal Investigator: Kristjan Karason, MD Sahlgrenska University Hospital, Sweden
  More Information

No publications provided

Responsible Party: NovaShunt AG Identifier: NCT00907673     History of Changes
Other Study ID Numbers: 2008-CHF-001
Study First Received: May 21, 2009
Last Updated: December 16, 2011
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases processed this record on March 03, 2015