Status:
COMPLETED
The Automated Fluid Shunt (AFS)in Chronic Congestive Heart Failure
Lead Sponsor:
NovaShunt AG
Conditions:
Congestive Heart Failure
Ascites
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00907673
Start Date
May 1 2009
End Date
March 1 2010
Last Update
December 19 2011
Active Locations (1)
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1
Sahlgrenska University Hospital
Gothenburg, Sweden, 41345