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Alfapump Direct Sodium Removal (DSR) Feasibility Study

NCT04116034 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2021-05-28

No results posted yet for this study

Summary

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.

Conditions

  • Heart Failure
  • Congestive Heart Failure
  • Cardiorenal Syndrome
  • Volume Overload
  • Sodium Excess
  • Sodium Disorder

Interventions

DEVICE

alfapump DSR 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

Sponsors & Collaborators

  • Yale University

    collaborator OTHER

  • Sequana Medical N.V.

    lead INDUSTRY

Principal Investigators

  • Jozef Bartunek, MD · Onze Lieve Vrouw Hospital Aalst, Belgium

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-26
Primary Completion
2021-04-15
Completion
2021-04-15

Countries

  • Belgium
  • 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 NCT04116034 on ClinicalTrials.gov