Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 21, 2009
First Posted Date  ICMJE May 22, 2009
Last Update Posted Date December 19, 2011
Study Start Date  ICMJE May 2009
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00907673 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2009)
  • 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 ]
  • To determine change in LV volumes and LVEF (echocardiography) compared from baseline to 16 and 28 weeks [ Time Frame: 16 and 28 weeks ]
  • 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 ]
  • To determine change in renal function (GFR) compared from baseline to 16 and 28 weeks [ Time Frame: 16 and 28 weeks ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Automated Fluid Shunt (AFS)in Chronic Congestive Heart Failure
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Congestive Heart Failure
  • Ascites
Intervention  ICMJE Device: Automatic Fluid Shunt System
Fully implantable peritoneal catheter, bladder catheter, and pump
Other Name: AFS System
Study Arms  ICMJE Active Comparator: Patient condition pre-implant
Intervention: Device: Automatic Fluid Shunt System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 16, 2011)
2
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2009)
10
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00907673
Other Study ID Numbers  ICMJE 2008-CHF-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NovaShunt AG
Study Sponsor  ICMJE NovaShunt AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kristjan Karason, MD Sahlgrenska University Hospital, Sweden
PRS Account NovaShunt AG
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP