NCT05140759

An Automated Continual Water Removal System in Patients With Advanced Diuretic Resistant Heart Failure

A Multi-centre, Prospective, Open Label, Uncontrolled Pilot Study to Assess the Feasibility and Tolerability of an Automated Continual Water Removal System in Patients With Advanced Diuretic Resistant Heart Failure

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Paragate Medical LTD · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the functionality and tolerability of an automated continual water removal system in up to 8 patients with HF and diuretic resistance. intervention: Implanted absorption chamber, connected to an external pump. Follow up: 3 months post activation.

Detailed description

Study Duration: 24 months Enrolment 20 months, Follow-up 3 months, Close-out 1 month Study Centres Up to 4 centres with Medical University Wroclaw, Poland, as the principal site. Objectives: To assess the feasibility, tolerability and functionality of an intra-peritoneal, mechanically induced, ultrafiltration system, through the analysis of procedure and device related serious adverse events and device function. Number of Subjects: Up to 8 Diagnosis and Main Inclusion Criteria: Patients with fluid overloaded congested heart failure (NYHA Class II-IV) with diuretic resistance and a history of multiple heart failure related admissions. 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 the external fluid drainage bag. Statistical Methodology: No statistical hypothesis is proposed. Safety will be evaluated using a complete description of Serious Adverse Events. A descriptive analysis will be performed for all primary and secondary variables of the study for the basal measures and all post-basal measures.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	automated continual water removal system	The device removes excess fluids in heart failure patients with diuretic resistance

Timeline

• Start date: 2022-02-24
• Primary completion: 2024-01-17
• Completion: 2024-01-17
• First posted: 2021-12-01
• Last updated: 2024-01-19

Locations

3 sites across 3 countries: Georgia, Israel, Poland