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

Primary Purpose

Congestive Heart Failure, Ascites

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Automatic Fluid Shunt System
Sponsored by
NovaShunt AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Patient condition pre-implant

Arm Description

Outcomes

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.

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
To determine change in LV volumes and LVEF (echocardiography) compared from baseline to 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
To determine change in renal function (GFR) compared from baseline to 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

Full Information

First Posted
May 21, 2009
Last Updated
December 16, 2011
Sponsor
NovaShunt AG
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1. Study Identification

Unique Protocol Identification Number
NCT00907673
Brief Title
The Automated Fluid Shunt (AFS)in Chronic Congestive Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NovaShunt AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Ascites

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient condition pre-implant
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Automatic Fluid Shunt System
Other Intervention Name(s)
AFS System
Intervention Description
Fully implantable peritoneal catheter, bladder catheter, and pump
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
To determine change in LV volumes and LVEF (echocardiography) compared from baseline to 16 and 28 weeks
Time Frame
16 and 28 weeks
Title
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
Title
To determine change in renal function (GFR) compared from baseline to 16 and 28 weeks
Time Frame
16 and 28 weeks
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristjan Karason, MD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Göteborg
ZIP/Postal Code
41345
Country
Sweden

12. IPD Sharing Statement

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

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