Overview

Safety & Feasibility of DSR TherApy in Heart FAiluRe pAtients With Persistent Congestion

Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
Feasibility and safety study of the alfapump DSR system in the treatment of volume overloaded heart failure subjects receiving high doses of loop diuretics. Up to 24 subjects will be enrolled in up to 3 centres in Republic of Georgia, and randomized into 2 parallel treatment arms. Once implanted with the alfapump DSR system they will undergo DSR therapy in 2 phases: intensive treatment phase followed by maintenance treatment phase.
Phase:
N/A
Details
Lead Sponsor:
Sequana Medical N.V.
Treatments:
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Dapagliflozin
Sodium-Glucose Transporter 2 Inhibitors