Optimal Balance Alfapump® System Feasibility Study

Phase 1

Withdrawn

• Conditions: Heart Failure
• Interventions: Device: Alfapump

• Registration Number: NCT03032211
• Lead Sponsor: Sequana Medical N.V.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-11
• Study First Submitted QC: 2017-01-23
• Study First Posted: 2017-01-26
• Study Start: 2017-12-31
• Status Verified: 2018-04
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Last Update Submitted: 2021-03-18
• Last Update Posted: 2021-03-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Alfapump	Alfapump

Primary Outcome Measures

Name	Time	Method
Occurrence of adverse events (AEs) and serious adverse events (SAEs)	Q1 2017 and Q3 2017	4 weeks after the third patient implanted an initial safety review will be done and after the last patient completed 3 months of dialysate administration.

Trial Locations

Locations (1)

Military Hospital - State Health Centre; 🇭🇺 Budapest, Hungary