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

Heart Failure

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

Inclusion Criteria10

≥ 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

Exclusion Criteria29

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
Current gastrointestinal active infection in the body (such as Clostridium difficile infection)
Gastrointestinal haemorrhage within the last 4 months
Bacterial peritonitis episode within the last 24 months
\> 2 systemic or local infections, such as urinary tract infection or abdominal skin infection within the last 6 months
Class B or C liver cirrhosis of non-cardiac aetiology
\> body mass index (BMI) \> 40 presenting a risk for surgery
Patients with contraindications for general/local anaesthesia, sedation and
or Percutaneous / Laparoscopic surgery
Unsuitability for self-maintenance of the experimental home set-up
Presence of any current cancer, subject to PI discretion
Presence of any active implantable or body-worn devices that cannot be removed excluding Implantable Cardioverter-Defibrillator (ICD) / pacemaker, subject to PI discretion
Known hypersensitivity to Nitinol nickel/titanium alloy and brilliant blue
Pregnancy
Patients being in another therapeutic clinical study

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