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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NovaShunt AG
ClinicalTrials.gov Identifier:
NCT00907673
First received: May 21, 2009
Last updated: December 16, 2011
Last verified: December 2011
History of Changes
  Purpose

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 Intervention
Congestive Heart Failure
Ascites
 Device: Automatic Fluid Shunt System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

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

Further study details as provided by NovaShunt AG:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To determine change in LV volumes and LVEF (echocardiography) compared from baseline to 16 and 28 weeks [ Time Frame: 16 and 28 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To determine change in renal function (GFR) compared from baseline to 16 and 28 weeks [ Time Frame: 16 and 28 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: May 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Patient condition pre-implant Device: Automatic Fluid Shunt System
Fully implantable peritoneal catheter, bladder catheter, and pump
Other Name: AFS System

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907673

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

No publications provided

Responsible Party: NovaShunt AG
ClinicalTrials.gov Identifier: NCT00907673     History of Changes
Other Study ID Numbers: 2008-CHF-001
Study First Received: May 21, 2009
Last Updated: December 16, 2011
Health Authority: Sweden: Medical Products Agency

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

ClinicalTrials.gov processed this record on May 16, 2013