International Alfapump Cohort Study

Study Overview
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Brief Summary
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This Registry is designed to follow patients who have been implanted with an alfapump system, which is a newly marketed product from Sequana Medical AG, a Swiss Medical Device company.

Detailed Description
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In a real-world setting, all patients implanted with an alfapump system according to it's intended use, not participating in another clinical study in which the alfapump is studied.

Official Title
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International Alfapump Cohort Study: in Patients With Refractory Ascites Due to Liver Cirrhosis or Malignant Ascites With a Life Expectancy of 6 Months or Less

Conditions
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Liver Cirrhoses, Malignant Ascites

Intervention / Treatment
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* Device: Alfapump


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients implanted with an alfapump are eligible for this registry Exclusion Criteria: Patients younger than 18 years Pregnancy Inability to operate the Smart Charger to recharge the alfapump Participating in another study in which the alfapump is studied
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Alfapump|alfapump implementation|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient survival at 6 months post implant | The primary outcome will be patient survival with a functional alfapump system at 6 months. | 6 months post-implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess occurrence of (major) reportable events. | Reportable events are defined as any events per the definition in 9.1 and classified as renal event, variceal bleeding, hepatic encephalopathy an infection or assessed as related (not classified improbable related or cannot be attributed per the definitions below) to; the implant procedure, device or therapy by the treating physician. | 2 years | 
| To assess safety at 1-month post implant for procedure related incidents. | o Occurrence of adverse events considered related to implant, product or therapy by the treating physician | 1 month post implant | 
| Clinical impact on liver and renal function in liver & renal blood lab panel | Clinical impact as assessed by changes in Prealbumin | 2 years | 
| Clinical impact on liver and renal function in liver & renal blood lab panel | Clinical impact as assessed by changes in Albumin. | 2 years | 
| Clinical impact on liver and renal function in liver & renal blood lab panel | Clinical impact as assessed by changes in eGFR. | 2 years | 
| Clinical impact on liver and renal function in liver & renal blood lab panel | Clinical impact as assessed by changes in createnine. | 2 years | 
| Impact of the alfapump on ascites symptoms related quality of life | Ascites Questionnaire (pre implant & at each visit after the first month post implant) | 2 years | 
| Impact of the alfapump on ascites symptoms related quality of life | SF-36 (pre implant at each visit after the first month post implant) | 2 years | 
| Impact of the alfapump on ascites symptoms related quality of life on patient activity | Assess change in physical activity pre- and post implant To assess daily activity and stress level of patients for up to 48 weeks following implant | 1 week pre-implant, Day 0 Implant, 4 weeks-, 8 weeks-, 16 weeks-, 24 weeks- and 48 weeks post implant | 
| Impact of the alfapump on ascites symptoms related quality of life on patient activity | Assess change in physical activity pre- and post implant To assess and evaluate sleep of patients for up to 48 weeks following implant | 1 week pre-implant, Day 0 Implant, 4 weeks-, 8 weeks-, 16 weeks-, 24 weeks- and 48 weeks post implant | 
| Impact of the alfapump on ascites symptoms related quality of life on patient activity | Assess change in physical activity pre- and post implant To assess daily activity and stress level of patients for up to 48 weeks following implant To assess and evaluate sleep of patients for up to 48 weeks following implant To assess patient's abdominal pain/discomfort, appetite, satiety, and tiredness To assess objective stress and inflammation parameters | 1 week pre-implant, Day 0 Implant, 4 weeks-, 8 weeks-, 16 weeks-, 24 weeks- and 48 weeks post implant | 
| Impact of the alfapump on ascites symptoms related quality of life on patient activity | Assess change in physical activity pre- and post implant To assess patient's abdominal pain/discomfort, appetite, satiety, and tiredness | 1 week pre-implant, Day 0 Implant, 4 weeks-, 8 weeks-, 16 weeks-, 24 weeks- and 48 weeks post implant | 
| Impact of the alfapump on ascites symptoms related quality of life on patient activity | Assess change in physical activity pre- and post implant To assess objective stress and inflammation parameters | 1 week pre-implant, Day 0 Implant, 4 weeks-, 8 weeks-, 16 weeks-, 24 weeks- and 48 weeks post implant | 
| Clinical impact on ECOG | change in ECOG performance scale pre- and post implant | 2 years |