Heart FailureCLEAR-HFNCT06689553
Percutaneously Delivered Automated Continual Fluid Removal System in Patients With Advanced Diuretic-Resistant Heart Failure
A study testing Automated Continual Fluid Removal System in people with Heart Failure, run by Paragate Medical LTD at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Automated Continual Fluid Removal System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 28 Sep 2025to 5 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
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- 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
Who cannot join
- 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.)
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- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Serbia2 sites
University Clinical Centre of Serbia
Belgrade, Visegradska 26, 11000
University Clinical Hospital Medical Center "Bezanijska kosa"
Belgrade, 11080
Spain1 site
Hospital Clínico Universitario de Valencia-España
Valencia, Spain, 17 46010
About this study
Official title: 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.
Read the detailed description
Objectives: To assess the feasibility, safety, tolerability and functionality of an intra-peritoneal, mechanically induced ultrafiltration system (IPUDx), through the analysis of procedure and device related serious adverse events and device function.
Study Duration: Up to 24 months. Enrolment 15 months, Activation following implantation (per patient) up to 1 month, Follow-up (per patient) 6 months, Close-out 2 months.
Number of Subjects: Up to 8 Diagnosis and Main Inclusion Criteria: Patients with fluid overloaded congested heart failure (The New York Heart Association Class II-IV) with diuretic resistance and a history of multiple heart failure related admissions.
Study Centers: Up to 5 Medical Centers in Serbia and Spain.
Study Product and Planned Use: The Paragate Medical IPUDx System comprises an intraperitoneally implanted fluid absorption chamber with an external wearable rechargeable pump, drainage bag and controller.
The system induces isotonic fluid loss across the peritoneal membranes which is collected in the fluid absorption chamber and transported to a daily disposable external fluid drainage bag.
Statistical Methodology: No statistical hypothesis is proposed. Safety will be evaluated using a complete description of Serious Adverse Events (SAEs). A descriptive analysis will be performed for all primary and secondary variables of the study for the basal measures and all post-basal measures. Interim analysis for all the study endpoints will be performed at the completion of the active follow up phase (3 months post activation). Safety analysis for Adverse Device Effects (ADEs) will be performed both at 3-month post activation and at the completion of maintenance phase (6 months post implantation).
- Conditions
- Heart Failure
- Being tested
- Automated Continual Fluid Removal System
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated Continual Fluid Removal SystemDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Intraperitoneal implanted device | Experimental | Implantation and activation of an automated continual water removal system Receives: Device: Automated Continual Fluid Removal System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of AEs related to implantation
based on analysis of the incidence of serious adverse events related to the implantation procedure.
Measured: 3 months post activation
Serious Adverse Events related to the device
Based on the incidence of serious adverse events related to the device
Measured: 3 months post activation and 6 months from implantation
Successful Implantation Rate
based on post-insertion imaging confirmation utilizing imaging modalities such as X-rays to confirm the appropriate placement and positioning of the chamber within the peritoneal cavity (appropriate placement yes/no)
Measured: 3 months post activation
Secondary outcomes (11)
Device Functionality
assessed by: Weekly measurements of fluid removal volume (ml)
Measured: 3 months post activation
Clinical assessment of fluid overload
A composite score evaluating fluid overload, incorporating physical examination findings (e.g., presence of edema, jugular venous distension) and patient-reported symptoms. Each clinical sign will be assessed individually and aggregated into a composite score to quantify the degree of fluid overload, allowing assessment of the intervention's effectiveness in managing fluid balance over time
Measured: 3 months post activation
Effectiveness of the drainage fluid
assessed by comparing the sodium concentration in the drained fluid to the sodium concentration in the 24-hour urine collection and multiplying this ratio by the volume of the drained fluid
Measured: 3 months post activation
Echocardiographic assessment
Evaluation of cardiac structure and function through echocardiographic imaging, with measurements including ventricular volumes, ejection fraction, and wall motion. These assessments will be aggregated to provide a comprehensive echocardiographic profile as a single outcome, focusing on overall cardiac function and structural changes over time
Measured: 3 months post activation
Quality of life questionnaire (KCCQ-12 questionnaire)
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period.
KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Measured: 3 months post activation
6 minutes' walk test
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: 3 months post activation
Number of HF congestion related hospital admissions
Tracking the frequency of hospital admissions specifically related to heart failure (HF) congestion, as an indicator of the device's impact on patient symptoms and management of HF-related complications
Measured: 3 months post activation
Dyspnoea Score
assessed by using the Modified Borg Dyspnoea scale at rest - before and during 6 minutes walk test. This is a scale that asks the patient to rate the difficulty of his breathing. It starts at number 0 where breathing is causing no difficulty at all and progresses through to number 10 where breathing difficulty is maximal.
Measured: 3 months post activation
Markers of heart failure Severity:
Measurement of specific biomarkers associated with heart failure severity, including NT-proBNP, Antigen carbohydrate 125, Cystatin C, and Interleukin-6, to assess the physiological impact of the intervention on HF progression and patient health status
Measured: 3 months post activation
Levels of Serum Creatinine
Measurement of serum creatinine levels to evaluate kidney function and monitor potential changes associated with the intervention, providing insight into renal health in heart failure patients
Measured: 3 months post activation
Electrolytes levels
Assessment of serum electrolyte levels (e.g., sodium, potassium), reported as a combined outcome with consistent units (e.g., mEq/L) to evaluate changes in electrolyte balance, which can reflect kidney function and fluid status in heart failure patients
Measured: 3 months post activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start28 Sep 2025
- Primary completion5 May 2026
- Study completion5 May 2026
Why it 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paragate Medical LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marko Banović, MD, Principal investigator, University Clinical Centre of SerbiaMarija Zdravkovic, MD, Principal investigator, University Clinical Hospital Medical Center "Bezanijska kosa"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689553
- Sponsor's protocol ID
- PM10002
- Acronym
- CLEAR-HF
- Status last verified
- May 2026
- First submitted
- 5 Nov 2024
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06689553
- Acronym / sponsor ID
- CLEAR-HF / PM10002
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Paragate Medical LTDIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2025 (actual)
- Primary completion
- 5 May 2026 (actual)
- Study completion
- 5 May 2026 (actual)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives: To assess the feasibility, safety, tolerability and functionality of an intra-peritoneal, mechanically induced ultrafiltration system (IPUDx), through the analysis of procedure and device related serious adverse events and device function.
Study Duration: Up to 24 months. Enrolment 15 months, Activation following implantation (per patient) up to 1 month, Follow-up (per patient) 6 months, Close-out 2 months.
Number of Subjects: Up to 8 Diagnosis and Main Inclusion Criteria: Patients with fluid overloaded congested heart failure (The New York Heart Association Class II-IV) with diuretic resistance and a history of multiple heart failure related admissions.
Study Centers: Up to 5 Medical Centers in Serbia and Spain.
Study Product and Planned Use: The Paragate Medical IPUDx System comprises an intraperitoneally implanted fluid absorption chamber with an external wearable rechargeable pump, drainage bag and controller.
The system induces isotonic fluid loss across the peritoneal membranes which is collected in the fluid absorption chamber and transported to a daily disposable external fluid drainage bag.
Statistical Methodology: No statistical hypothesis is proposed. Safety will be evaluated using a complete description of Serious Adverse Events (SAEs). A descriptive analysis will be performed for all primary and secondary variables of the study for the basal measures and all post-basal measures. Interim analysis for all the study endpoints will be performed at the completion of the active follow up phase (3 months post activation). Safety analysis for Adverse Device Effects (ADEs) will be performed both at 3-month post activation and at the completion of maintenance phase (6 months post implantation).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraperitoneal implanted device | Experimental | Device: Automated Continual Fluid Removal SystemImplantation and activation of an automated continual water removal system |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥ 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)
Key exclusion criteria (29 listed)
- 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
- Immunocompromised (e.g. chronic steroid treatment, Human immunodeficiency virus (HIV), etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated Continual Fluid Removal SystemThe 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 | Device | Intraperitoneal implanted device |
Primary outcome
Analysis of AEs related to implantation
Time frame: 3 months post activation
based on analysis of the incidence of serious adverse events related to the implantation procedure.
Serious Adverse Events related to the device
Time frame: 3 months post activation and 6 months from implantation
Based on the incidence of serious adverse events related to the device
Successful Implantation Rate
Time frame: 3 months post activation
based on post-insertion imaging confirmation utilizing imaging modalities such as X-rays to confirm the appropriate placement and positioning of the chamber within the peritoneal cavity (appropriate placement yes/no)
11 secondary outcomes
Device Functionality
Time frame: 3 months post activation
Clinical assessment of fluid overload
Time frame: 3 months post activation
Effectiveness of the drainage fluid
Time frame: 3 months post activation
Echocardiographic assessment
Time frame: 3 months post activation
Quality of life questionnaire (KCCQ-12 questionnaire)
Time frame: 3 months post activation
6 minutes' walk test
Time frame: 3 months post activation
Number of HF congestion related hospital admissions
Time frame: 3 months post activation
Dyspnoea Score
Time frame: 3 months post activation
Markers of heart failure Severity:
Time frame: 3 months post activation
Levels of Serum Creatinine
Time frame: 3 months post activation
Electrolytes levels
Time frame: 3 months post activation
Results and safety
The study was stopped early (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). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marko Banović, MD principal investigator
University Clinical Centre of Serbia
Marija Zdravkovic, MD principal investigator
University Clinical Hospital Medical Center "Bezanijska kosa"
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated Continual Fluid Removal System in people with Heart Failure, run by Paragate Medical LTD at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Serbia, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (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). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of AEs related to implantation (time frame: 3 months post activation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.