NCT03032211

Optimal Balance Alfapump® System Feasibility Study

A Feasibility Clinical Study of Osmotic Pump Treatment in Fluid Management to Achieve Optimal Fluid Balance in NYHA Class III and Ambulatory NYHA Class IV Heart Failure Patients Who Have an Estimated Glomerular Filtration Rate of > 15 to < 60 mL/Min/1.73m2

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sequana Medical N.V. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Alfapump	Implant Alfapump® System

Timeline

• Start date: 2017-12-31
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2017-01-26
• Last updated: 2021-03-22

Locations

1 site across 1 country: Hungary