The Automated Fluid Shunt (AFS)in Chronic Congestive Heart Failure
NCT ID: NCT00907673
Last Updated: 2011-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2 participants
INTERVENTIONAL
2009-05-31
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patient condition pre-implant
Automatic Fluid Shunt System
Fully implantable peritoneal catheter, bladder catheter, and pump
Interventions
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Automatic Fluid Shunt System
Fully implantable peritoneal catheter, bladder catheter, and pump
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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NovaShunt AG
INDUSTRY
Responsible Party
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Principal Investigators
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Kristjan Karason, MD
Role: PRINCIPAL_INVESTIGATOR
Sahlgrenska University Hospital
Locations
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Sahlgrenska University Hospital
Gothenburg, , Sweden
Countries
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Other Identifiers
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2008-CHF-001
Identifier Type: -
Identifier Source: org_study_id