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

NovaShunt

Status

Completed

Conditions

Ascites

Congestive Heart Failure

Treatments

Device: Automatic Fluid Shunt System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00907673

2008-CHF-001

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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