AzTrials
AzTrials

Heart FailureACWR-HFNCT05140759

An Automated Continual Water Removal System in Patients With Advanced Diuretic Resistant Heart Failure

A study testing automated continual water removal system in people with Heart Failure, run by Paragate Medical LTD at 3 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This study will assess the functionality and tolerability of an automated continual water removal system in up to 8 patients with HF and diuretic resistance. intervention: Implanted absorption chamber, connected to an external pump. Follow up: 3 months post activation. 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 water removal system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
3 sitesin 3 countries
Study dates
24 Feb 2022to 17 Jan 2024
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
  • HF, 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 (eg. Furosemide and Metolazone)
Show all 10Show fewer
  • Eligible for general anaesthesia and laparoscopic procedure
  • Able to give written informed consent
  • Ability to comply with study procedures and ability to operate the device
  • 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 history, or with indication for, mechanical circulatory support
  • iv inotropes required in last 3 months (INTERMACS Score ≤3)
  • Immunocompromised (e.g. chronic steroid treatment, HIV, etc.)
  • Insulin dependent diabetes
Show all 24Show fewer
  • Severe hyponatraemia as defined by a serum Sodium < 120 mmol/l
  • Serum Albumin < 2.5 g/dL
  • eGFR < 25 ml/min/1.73m2 by MDRD method
  • Previous significant intraabdominal surgery, severe abdominal adhesions, intra-abdominal foreign body (except for small inguinal mesh)
  • Large diaphragmatic hernia, or surgically irreparable, complex or recurring hernia
  • 6 minutes' walk test of less than 100 meter
  • History (>6 months) of diaphragmatic hernia, inflammatory or ischemic bowel disease and frequent episodes of diverticulitis
  • 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
  • Liver cirrhosis
  • BMI > 40 presenting a risk for surgery
  • Patients with contraindications for general anaesthesia or laparoscopic surgery
  • Unsuitability for self-maintenance of the experimental home set-up
  • Presence of any current cancer
  • Presence of any active implantable or body-worn devices that cannot be removed excluding ICD / pacemaker
  • Pregnancy
  • Patients being in another therapeutic clinical study

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Georgia1 site

  • West Georgian Medical Center

    Kutaisi, 4600

Other trials in Georgia

Israel1 site

  • Rambam medical center

    Haifa

Other trials in Israel

Poland1 site

  • Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego

    Wroclaw, 50-556

Other trials in Poland

About this study

Official title: A Multi-centre, Prospective, Open Label, Uncontrolled Pilot Study to Assess the Feasibility and Tolerability of an Automated Continual Water Removal System in Patients With Advanced Diuretic Resistant Heart Failure

This study will assess the functionality and tolerability of an automated continual water removal system in up to 8 patients with HF and diuretic resistance.

intervention: Implanted absorption chamber, connected to an external pump. Follow up: 3 months post activation.

Read the detailed description

Study Duration: 24 months Enrolment 20 months, Follow-up 3 months, Close-out 1 month Study Centres Up to 4 centres with Medical University Wroclaw, Poland, as the principal site.

Objectives: To assess the feasibility, tolerability and functionality of an intra-peritoneal, mechanically induced, ultrafiltration system, through the analysis of procedure and device related serious adverse events and device function.

Number of Subjects: Up to 8 Diagnosis and Main Inclusion Criteria: Patients with fluid overloaded congested heart failure (NYHA Class II-IV) with diuretic resistance and a history of multiple heart failure related admissions.

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 the external fluid drainage bag.

Statistical Methodology: No statistical hypothesis is proposed. Safety will be evaluated using a complete description of Serious Adverse Events. A descriptive analysis will be performed for all primary and secondary variables of the study for the basal measures and all post-basal measures.

Conditions
Heart Failure
Being tested
automated continual water 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 water removal systemDevice

    The device removes excess fluids in heart failure patients with diuretic resistance

Study groups in NCT05140759
Study groupRoleWhat they receive
Implanted deviceExperimentalImplantation and activation of an automated continual water removal system, including 4-months follow up
Receives: Device: automated continual water removal system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Analysis of AEs related to implantation

    Analysis of incidence and severity of AEs that occur during or following implantation and are related to it.

    Measured: 4 months

  2. Analysis of AEs related to the device and its function.

    Analysis of incidence and severity of AEs related to the device and its function.

    Measured: 4 months

Secondary outcomes (9)

  1. Functionality

    Assessed by a daily volume of fluid removal

    Measured: 4 months

  2. Clinical assessment of fluid overload

    Fluid retention measures such as pitting oedema, jugular distention, body weight elevation

    Measured: 4 months

  3. Echocardiographic assessment of LVESD, LVEDD, and LVEF

    Data from echocardiography will enable the provision of volumes, diastolic function, right ventricular function, hemodynamics, and valvular regurgitation.

    This versatile tool is employed vastly for the management of heart failure.

    LVEF - Left Ventricular Ejection Fraction LVESD -Left Ventricular End-Systolic Diameters LVEDD - Left Ventricular external end-diastolic diameter

    Measured: 4 months

  4. 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: 4 months

  5. Nocturnal dyspnea score

    Will be assessed using the following questions:

    Has the patient ever woken up at night with shortness of breath? How long after lying down did the episode occur?

    Number of pillows used under the patient's head at night:

    Has the patient ever had to sleep sitting up? Has the patient developed coughing or wheezing in the recumbent position? What did the patient do to relieve his distress? Please specify.

    Measured: 4 months

  6. 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: 4 months

  7. NT-proBNP

    NT-proBNP is a marker for HF severity.

    Measured: 4 months

  8. Serum Creatinine

    A marker for kidney function.

    Measured: 4 months

  9. Serum / urine electrolytes levels.

    Electrolyte and metabolite disorders indicate on kidney function.

    hypercalcemia /hypocalcemia. hyperchloremia /hypochloremia. hypermagnesemia /hypomagnesemia. hyperphosphatemia /hypophosphatemia. hyperkalemia /hypokalemia. hypernatremia /hyponatremia.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2021
  2. Study start24 Feb 2022
  3. Primary completion17 Jan 2024
  4. Study completion17 Jan 2024

Why it stopped: challenges in recruitment

Resources

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
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05140759
Sponsor's protocol ID
PM-2020-10000 IPUDX
Acronym
ACWR-HF
Status last verified
Jan 2024
First submitted
9 Nov 2021
Last updated
19 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing automated continual water removal system in people with Heart Failure, run by Paragate Medical LTD at 3 sites in 3 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 24 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 19 Jan 2024. 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 Georgia, Israel, Poland. 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: challenges in recruitment). 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: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05140759.

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 19 Jan 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in