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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient condition pre-implant | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automatic Fluid Shunt System | Device | Fully implantable peritoneal catheter, bladder catheter, and pump |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristjan Karason, MD | Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Gothenburg | 41345 | Sweden |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D001201 | Ascites |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |