Percutaneous implant and external pump to continuously remove excess fluid for 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

This will test an implanted peritoneal absorption chamber plus an external wearable pump to continuously remove excess fluid in adults with advanced heart failure who no longer respond to diuretics.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 8 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Paragate Medical LTD (Industry-sponsored)
• Locations: 3 sites (Belgrade, Visegradska 26 and 2 other locations)
• Trial ID: NCT06689553 on ClinicalTrials.gov

What this trial studies

The device system consists of an intraperitoneally implanted fluid absorption chamber connected to an external wearable rechargeable pump, drainage bag and controller that moves isotonic fluid across the peritoneal membrane into a disposable bag. Up to eight patients with NYHA class II–IV heart failure and documented diuretic resistance and prior heart‑failure admissions will undergo percutaneous implantation and device activation. The study will primarily describe feasibility, safety, tolerability and device function, tracking procedure‑ and device‑related serious adverse events and performance over a six‑month post‑activation follow‑up (with total study duration up to 24 months). Enrollment will occur at up to five centers in Serbia and Spain with regular clinic visits and capability for home visits as needed.

Who should consider this trial

Good fit: Ideal candidates are adults (≥21 years) with NYHA class II–IV heart failure who have diuretic resistance, a history of multiple heart‑failure admissions, can consent and operate the device (or have caregiver support), and live near a participating center.

Not a fit: Patients whose congestion responds to conventional diuretics, who have limited life expectancy from noncardiac disease, or who have contraindications to an intraperitoneal device (for example active intra‑abdominal infection or extensive adhesions) are unlikely to benefit.

Why it matters

Potential benefit: If successful, the system could reduce fluid overload, relieve symptoms, and potentially lower hospital admissions in patients with diuretic‑resistant heart failure.

How similar studies have performed: Small nonrandomized studies of peritoneal ultrafiltration have shown symptom relief and fewer hospitalizations in select patients, but this specific percutaneously implanted automated continual fluid removal system is novel and not yet tested in larger trials.

Eligibility criteria

Inclusion Criteria:

* ≥ 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 Criteria:

* 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

  * 3), 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
* 6 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
* 18.5 \> 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

Where this trial is running

Belgrade, Visegradska 26 and 2 other locations

• University Clinical Centre of Serbia — Belgrade, Visegradska 26, Serbia (Recruiting)
• University Clinical Hospital Medical Center "Bezanijska kosa" — Belgrade, Serbia (Recruiting)
• Hospital Clínico Universitario de Valencia-España — Valencia, Spain, Spain (Not_yet_recruiting)

Study contacts

• Principal investigator: Marko Banović, MD — University Clinical Centre of Serbia
• Study coordinator: Inbal Eyal

Conditions Heart Failure