Actively Recruiting
Percutaneously Delivered Automated Continual Fluid Removal System in Patients With Advanced Diuretic-Resistant Heart Failure
Led by Paragate Medical LTD · Updated on 2025-07-30
8
Participants Needed
3
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Percutaneously Delivered Automated Continual Fluid Removal System in Patients With Advanced Diuretic-Resistant Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 21 years of age or older
- Life expectancy greater than 6 months
- Diagnosed with Heart Failure, New York Heart Association (NYHA) class II-IV
- More than 1 heart failure related admission in the last 12 months
- Signs of fluid congestion such as pitting edema, jugular distension, body weight elevation, nocturnal dyspnea, respiratory rate changes, pulmonary congestion, pleural effusion, or ascites
- Failure to achieve effective diuresis despite appropriate or increasing diuretic doses or combination therapy
- Able to provide written informed consent
- Ability to comply with study procedures and operate the device themselves or with regular caregiver support
- Residence near the medical center to ensure easy access to hospital and home visits
- Women of childbearing potential must use effective contraception while the device is implanted
You will not qualify if you...
- Any non-cardiac disease with life expectancy less than 1 year
- Listed for solid organ transplantation
- History or indication for mechanical circulatory support
- Intravenous inotropes required in the last 3 months (except Levosimendan)
- Immunocompromised conditions such as chronic steroid treatment or HIV
- Insulin dependent diabetes with evidence of infection
- Severe hyponatremia (serum sodium less than 120 mmol/l)
- Serum albumin less than 2.5 g/dl
- Estimated glomerular filtration rate (eGFR) less than 20 ml/min/1.73m2
- Previous significant intra-abdominal surgery, severe abdominal adhesions, or intra-abdominal foreign body (except small inguinal mesh)
- Large diaphragmatic hernia currently or within last 6 months, or surgically irreparable hernia
- Six-minute walk test less than 100 meters on repeated tests
- Severe or repeated cardiac-related ascites as judged by the principal investigator
- Inflammatory or ischemic bowel disease such as Crohn's disease, ulcerative colitis, or frequent diverticulitis
- Current gastrointestinal active infection like Clostridium difficile
- Gastrointestinal hemorrhage within the last 4 months
- Bacterial peritonitis episode within the last 24 months
- More than 2 systemic or local infections in the last 6 months
- Class B or C liver cirrhosis of non-cardiac origin
- Body mass index less than 18.5 or greater than 40 with surgical risk
- Contraindications to anesthesia, sedation, or percutaneous/laparoscopic surgery
- Unsuitable for self-maintenance of home device setup
- Presence of current cancer as judged by principal investigator
- Presence of active implantable or body-worn devices that cannot be removed (excluding ICD/pacemaker)
- Known hypersensitivity to Nitinol nickel/titanium alloy or brilliant blue
- Pregnancy
- Participation in another therapeutic clinical study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University Clinical Centre of Serbia
Belgrade, Visegradska 26, Serbia, 11000
Actively Recruiting
2
University Clinical Hospital Medical Center "Bezanijska kosa"
Belgrade, Serbia, 11080
Actively Recruiting
3
Hospital Clínico Universitario de Valencia-España
Valencia, Spain, Spain, 17 46010
Not Yet Recruiting
Research Team
I
Inbal Eyal
CONTACT
N
Nitai Hanani
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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