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

NCT06689553 | Terminated

• 1 other identifier: PM10002
• Study Type: interventional
• Target: 2
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (3)

• Analysis of AEs related to implantation

  based on analysis of the incidence of serious adverse events related to the implantation procedure.

  3 months post activation

• Serious Adverse Events related to the device

  Based on the incidence of serious adverse events related to the device

  3 months post activation and 6 months from implantation

• Successful Implantation Rate

  based on post-insertion imaging confirmation utilizing imaging modalities such as X-rays to confirm the appropriate placement and positioning of the chamber within the peritoneal cavity (appropriate placement yes/no)

  3 months post activation

Secondary Outcomes (11)

• Device Functionality

  3 months post activation

• Clinical assessment of fluid overload

  3 months post activation

• Effectiveness of the drainage fluid

  3 months post activation

• Echocardiographic assessment

  3 months post activation

• Quality of life questionnaire (KCCQ-12 questionnaire)

  3 months post activation

Study Arms (1)

Intraperitoneal implanted device

EXPERIMENTAL

Implantation and activation of an automated continual water removal system

Device: Automated Continual Fluid Removal System

Interventions

Automated Continual Fluid Removal System DEVICE

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

Intraperitoneal implanted device

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 21 years of age
• Life expectancy \> 6 months
• Heart Failure, New York Heart Association (NYHA) class II-IV
• \> 1 HF related admissions in the last 12 months
• Fluid congestion (2 signs of pitting oedema, jugular distention, BW elevation, nocturnal dyspnoea score, respiration rate, pulmonary congestion and/or pleural effusion per chest x-ray, ascites)
• Failure to achieve effective diuresis and congestion relief despite appropriate or escalating diuretic doses or combination of diuretics
• Able to give written informed consent
• Ability to comply with study procedures and ability to operate the device themselves or by a regular caregiver support
• Residence in proximity to the medical center to ensure easy access for required hospital visits and to enable home visits
• Women of childbearing potential should use adequate contraception for as long as the device is implanted

You may not qualify if:

• Any non-cardiac disease with life expectancy \< 1 year
• Any patient listed for solid organ transplantation
• Patients with a history, or with an indication for mechanical circulatory support
• intravenous (IV) inotropes required in last 3 months (INTERMACS Score
• ), excluding Levosimendan
• Immunocompromised (e.g. chronic steroid treatment, Human immunodeficiency virus (HIV), etc.)
• Insulin dependent diabetes with evidence of infection
• Severe hyponatremia as defined by a serum Sodium \< 120 mmol/l
• Serum Albumin \< 2.5 g/Dl
• Glomerular filtration rate (eGFR) \< 20 ml/min/1.73m2 by MDRD method, using MDRD 4-variable equation that includes age, sex, ethnicity, and serum creatinine
• Previous significant intraabdominal surgery, severe abdominal adhesions, intra-abdominal foreign body (except for small inguinal mesh)
• Current or historical (within last 6 months) large diaphragmatic hernia, or surgically irreparable, complex or recurring hernia
• minutes walk test of less than 100 meters in all repeated testing (if applicable), or similar test
• Severe, multiple repeated cardiac-related ascites, subject to principal investigator (PI) discretion
• Inflammatory or ischemic bowel disease (i.e., Crohn's disease, ulcerative colitis) and frequent episodes of diverticulitis

Sponsors & Collaborators

• Paragate Medical LTD: lead

Study Sites (3)

University Clinical Centre of Serbia

Belgrade, Visegradska 26, 11000, Serbia

Location

University Clinical Hospital Medical Center "Bezanijska kosa"

Belgrade, 11080, Serbia

Location

Hospital Clínico Universitario de Valencia-España

Valencia, Spain, 17 46010, Spain

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Marko Banović, MD

  University Clinical Centre of Serbia

  PRINCIPAL INVESTIGATOR

• Marija Zdravkovic, MD

  University Clinical Hospital Medical Center "Bezanijska kosa"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 14, 2024
• Study Start: September 28, 2025
• Primary Completion: May 5, 2026
• Study Completion: May 5, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

SE (2); ES (1)