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

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ClinicalTrials.gov Identifier: NCT00907673
Recruitment Status : Completed
First Posted : May 22, 2009
Last Update Posted : December 19, 2011
Sponsor:
Information provided by (Responsible Party):
NovaShunt AG

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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Ascites Device: Automatic Fluid Shunt System Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Patient condition pre-implant Device: Automatic Fluid Shunt System
Fully implantable peritoneal catheter, bladder catheter, and pump
Other Name: AFS System



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00907673


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

Responsible Party: NovaShunt AG
ClinicalTrials.gov Identifier: NCT00907673     History of Changes
Other Study ID Numbers: 2008-CHF-001
First Posted: May 22, 2009    Key Record Dates
Last Update Posted: December 19, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Heart Failure
Ascites
Heart Diseases
Cardiovascular Diseases
Pathologic Processes