RecruitingNot ApplicableNCT06689553

Percutaneously Delivered Automated Continual Fluid Removal System in Patients With Advanced Diuretic-Resistant Heart Failure

A Multi-Center, Multinational, Prospective, Open-Label, Single Arm, Pilot Study to Assess the Feasibility, Safety and Tolerability of a Percutaneously Delivered Automated Continual Fluid Removal System in Patients With Advanced Diuretic-Resistant Heart Failure


Sponsor

Paragate Medical LTD

Enrollment

8 participants

Start Date

Sep 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The study aims to assess the feasibility, safety, tolerability and functionality of a percutaneously delivered automated continual fluid removal System in up to 8 patients with Heart Failure (HF) and diuretic resistance. Intervention: Implanted absorption chamber, connected to an external pump. Follow up: 6 months post activation.


Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an automated device that continuously removes excess fluid from the body through a small tube placed under the skin. It is designed for people with advanced heart failure whose bodies retain fluid (causing swelling and breathing difficulties) even when taking high doses of water pills (diuretics). **You may be eligible if...** - You are 21 or older - You have heart failure (NYHA Class II–IV) - You have been hospitalised for heart failure more than once in the past year - You have signs of fluid overload (leg swelling, fluid in lungs, weight gain) - Diuretics (water pills) have not been enough to manage your fluid **You may NOT be eligible if...** - Your life expectancy is less than 6 months - You have active infections or certain bleeding conditions - You have had recent major surgery or procedures - Your kidneys are severely impaired Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAutomated Continual Fluid Removal System

The intraperitoneal device is percutaneously implanted via mini laparotomy, under local anaesthesia and sedation, and connected to the wearable rechargeable pump through extracorporeal tubing. The device aims to remove excess fluids in heart failure patients with diuretic resistance


Locations(3)

University Clinical Centre of Serbia

Belgrade, Visegradska 26, Serbia

University Clinical Hospital Medical Center "Bezanijska kosa"

Belgrade, Serbia

Hospital Clínico Universitario de Valencia-España

Valencia, Spain, Spain

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NCT06689553


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