First in Human feasibility and sfafety study of the alfapump DSR system in the treatment of Heart failure subects resistant to diuretic therapy. Up to 10 subjects will be enrolled in up to 3 centres in Belgium and Georgia and will be iplanted with the alfapump DSR system. Subjects will undergo DSR titration during a 2 week hospitalisation period, and will continue titrated DSR therapy as outpatients for 4 more weeks.
Age range
18 Years
Sex
ALL
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Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Safety in-hospital - Device related
Timeframe: Through Day 14 of treatment period
Safety in-hospital - therapy related
Timeframe: Through Day 14 of treatment period
Safety in-hospital - procedure related
Timeframe: Through Day 14 of treatment period
Safety during treatment period - device related
Timeframe: through Day 42 of treatment period
Safety during treatment period - procedure related
Timeframe: through Day 42 of treatment period
Safety during treatment period - therapy related
Timeframe: through Day 42 of treatment period