NCT06689553

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Paragate Medical LTD · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Objectives: To assess the feasibility, safety, tolerability and functionality of an intra-peritoneal, mechanically induced ultrafiltration system (IPUDx), through the analysis of procedure and device related serious adverse events and device function. Study Duration: Up to 24 months. Enrolment 15 months, Activation following implantation (per patient) up to 1 month, Follow-up (per patient) 6 months, Close-out 2 months. Number of Subjects: Up to 8 Diagnosis and Main Inclusion Criteria: Patients with fluid overloaded congested heart failure (The New York Heart Association Class II-IV) with diuretic resistance and a history of multiple heart failure related admissions. Study Centers: Up to 5 Medical Centers in Serbia and Spain. Study Product and Planned Use: The Paragate Medical IPUDx System comprises an intraperitoneally implanted fluid absorption chamber with an external wearable rechargeable pump, drainage bag and controller. The system induces isotonic fluid loss across the peritoneal membranes which is collected in the fluid absorption chamber and transported to a daily disposable external fluid drainage bag. Statistical Methodology: No statistical hypothesis is proposed. Safety will be evaluated using a complete description of Serious Adverse Events (SAEs). A descriptive analysis will be performed for all primary and secondary variables of the study for the basal measures and all post-basal measures. Interim analysis for all the study endpoints will be performed at the completion of the active follow up phase (3 months post activation). Safety analysis for Adverse Device Effects (ADEs) will be performed both at 3-month post activation and at the completion of maintenance phase (6 months post implantation).

Conditions

• Heart Failure

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-09-28
• Primary completion: 2026-07-30
• Completion: 2026-12-30
• First posted: 2024-11-14
• Last updated: 2025-07-30

Locations

3 sites across 2 countries: Serbia, Spain