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Completed

NCT Number: NCT00907673

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Automatic Fluid Shunt System

Device

Fully implantable peritoneal catheter, bladder catheter, and pump

Other names: AFS System

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. To determine change in LV volumes and LVEF (echocardiography) compared from baseline to 16 and 28 weeks

    Time frame: 16 and 28 weeks

  3. 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

  4. To determine change in renal function (GFR) compared from baseline to 16 and 28 weeks

    Time frame: 16 and 28 weeks

  5. 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

Sponsors and collaborators

Lead sponsor

NovaShunt AG

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 22, 2009
Registry last updated
Dec 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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