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Optimal Balance Alfapump® System Feasibility Study

NCT03032211 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-03-22

No results posted yet for this study

Summary

1\. Summary of Clinical Investigation

A summary of the clinical investigation is provided below and includes the primary objective of the study, the safety and feasibility endpoints, the number of subjects to be enrolled, the study duration, the subject follow-up and the inclusion/exclusion criteria.

1. Primary Objective

The primary objective of the study is to evaluate the safety and feasibility of the alfapump® System indication for use in the management of fluid in NYHA Class III and ambulatory NYHA Class IV heart failure patients who have an eGFR of \> 15 to \< 60 mL/min/1.73m2.
2. Study Endpoints

1. Primary Safety Endpoint

The primary safety endpoint will be an assessment of the occurrence of adverse events (AEs) and serious adverse events (SAEs) related to:
1. Surgical implant of the alfapump®
2. Device malfunctions
3. Dialysate infusion
2. Secondary Safety Endpoints

The secondary endpoint will be an assessment of:
1. Time to first hospitalization related to fluid management after the activation of the alfapump® System and initiation of dialysate infusion has occurred
2. Rate of occurrence of re-hospitalizations related to fluid management
3. All-cause mortality
3. Assessment of Feasibility for Fluid Management in Heart Failure Indication The feasibility of the alfapump® System for management of fluid in NYHA Class III and ambulatory NYHA Class IV heart failure patients with renal dysfunction will be assessed by the net fluid balance as measured by the ability of the alfapump® System to move more fluid to the bladder than dialysate instilled.

Conditions

Interventions

DEVICE

Alfapump

Implant Alfapump® System

Sponsors & Collaborators

  • Sequana Medical N.V.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-31
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Hungary

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 NCT03032211 on ClinicalTrials.gov