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

NCT04882358 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-11-09

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

ALFAPUMP DSR (DIRECT SODIUM REMOVAL) SYSTEM

Infusion of sodium free Dextrose 10% into peritoneal cavity to remove sodium and fluid using principles of peritoneal dialysis; sodium and ultrafiltrate will be evacuated to the bladder by the alfapump

DRUG

SGLT2 inhibitor

treatment with a standard dose of SGLT-2 inhibitor

Sponsors & Collaborators

  • Sequana Medical N.V.

    lead INDUSTRY

Principal Investigators

  • TAMAZ SHABURISHVILI, MD · TBILISI HEART & VASCULAR CLINIC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-27
Primary Completion
2022-08-31
Completion
2024-12-31

Countries

  • Georgia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04882358 on ClinicalTrials.gov