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RECRUITING
NCT06689553
NA

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

Sponsor: Paragate Medical LTD

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2025-09-28

Completion Date

2026-12-30

Last Updated

2025-07-30

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Automated 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