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.
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.
Study Type
OBSERVATIONAL
Enrollment
400
alfapump implementation
Universitätsklinikum Leipzig
Leipzig, Germany
Inselspital
Bern, Switzerland
Patient survival at 6 months post implant
The primary outcome will be patient survival with a functional alfapump system at 6 months.
Time frame: 6 months post-implant
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.
Time frame: 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
Time frame: 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
Time frame: 2 years
Clinical impact on liver and renal function in liver & renal blood lab panel
Clinical impact as assessed by changes in Albumin.
Time frame: 2 years
Clinical impact on liver and renal function in liver & renal blood lab panel
Clinical impact as assessed by changes in eGFR.
Time frame: 2 years
Clinical impact on liver and renal function in liver & renal blood lab panel
Clinical impact as assessed by changes in createnine.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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 1. To assess daily activity and stress level of patients for up to 48 weeks following implant 2. To assess and evaluate sleep of patients for up to 48 weeks following implant 3. To assess patient's abdominal pain/discomfort, appetite, satiety, and tiredness 4. To assess objective stress and inflammation parameters
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 2 years