Percutaneously Delivered Automated Continual Fluid Removal System in Patients With Advanced Diuretic-Resistant Heart Failure
Reason given: he clinical investigation was terminated prematurely by the Sponsor (Paragate-Medical Ltd.) due to financial restrictions. This decision was exclusively administrative and commercial in nature, and was not related to safety, any adverse clinical find
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Trial details
- Who runs it
- Paragate Medical LTD
- Trial code
- NCT06689553
- Record updated
- 15 May 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: ≥ 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: Any patient listed for solid organ transplantation; Previous significant intraabdominal surgery, severe abdominal adhesions, intra-abdominal foreign body (except for small inguinal mesh); 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; Any non-cardiac disease with life expectancy < 1 year; Immunocompromised (e.g. chronic steroid treatment, Human immunodeficiency virus (HIV), etc.); Insulin dependent diabetes with evidence of infection; 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; > 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; Presence of any current cancer, subject to PI discretion; Known hypersensitivity to Nitinol nickel/titanium alloy and brilliant blue; 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; 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; 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; Bacterial peritonitis episode within the last 24 months; Unsuitability for self-maintenance of the experimental home set-up; Presence of any active implantable or body-worn devices that cannot be removed excluding Implantable Cardioverter-Defibrillator (ICD) / pacemaker, subject to PI discretion; Pregnancy; Patients being in another therapeutic clinical study.