TerminatedNot Applicable

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

Stopped: 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

Serbia, Spain2 participantsStarted 2025-09-28

Plain-language 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.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Analysis of AEs related to implantation

Timeframe: 3 months post activation

Serious Adverse Events related to the device

Timeframe: 3 months post activation and 6 months from implantation

Successful Implantation Rate

Timeframe: 3 months post activation

Trial details

NCT IDNCT06689553

SponsorParagate Medical LTD

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05-05

View on ClinicalTrials.gov More Heart Failure trials