NCT00907673

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

December 19, 2011

Status Verified

December 1, 2011

Enrollment Period

10 months

First QC Date

May 21, 2009

Last Update Submit

December 16, 2011

Conditions

Congestive Heart FailureAscites

Outcome Measures

Primary Outcomes (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.

    16 and 28 weeks

Secondary Outcomes (5)

  • 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

    16 and 28 weeks

  • To determine change in LV volumes and LVEF (echocardiography) compared from baseline to 16 and 28 weeks

    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

    16 and 28 weeks

  • To determine change in renal function (GFR) compared from baseline to 16 and 28 weeks

    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

    baseline to 4, 12 and 28 week

Study Arms (1)

Patient condition pre-implant

ACTIVE COMPARATOR
Device: Automatic Fluid Shunt System

Interventions

Automatic Fluid Shunt SystemDEVICE

Fully implantable peritoneal catheter, bladder catheter, and pump

Also known as: AFS System
Patient condition pre-implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

MeSH Terms

Conditions

Heart FailureAscites

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kristjan Karason, MD

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2009

First Posted

May 22, 2009

Study Start

May 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

December 19, 2011

Record last verified: 2011-12

Locations

SE(1)