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New catheter offers hope for heart failure patients resistant to diuretics

NCT ID NCT05876078

Disease control Sponsor: Revamp Medical Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new device called the Doraya Catheter in 25 hospitalized heart failure patients whose bodies were not responding well to standard water pills (diuretics). The goal was to see if the catheter could safely and effectively remove excess fluid. The study focused on safety and urine output, not on curing heart failure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

25 people

The number who actually took part.

Started

Jul 2024

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject is hospitalized with primary diagnosis of ADHF. 2. N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,000 pg/m orvBNP≥250 pg/mL. 3. Evidence of fluid overload. 4. Subject insufficiently responds to IV diuretic therapy Exclusion Criteria: Systolic blood pressure \< 80 mmHg at the time of screening. 2. Acute myocardial infarction or acute coronary syndrome or cardiogenic shock or pleurocentesis within past 14 days or cardiovascular intervention within past 14 days. 3. Complex congenital heart disease (e.g., Tetralogy of Fallot subjects, single ventricle physiology). 4\. Known active myocarditis, hypertrophic obstructive cardiomyopathy, infiltrative cardiomyopathy (e.g., amyloidosis), constrictive pericarditis or cardiac tamponade. 5\. Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such as severe stenosis \\severe regurgitation) or Severe mitral disease with planned intervention. 6\. Evidence of active systemic infection documented by either one of the following: fever \>38°C/100°F, or ongoing uncontrolled infection (i.e., inflammatory parameters not decreasing despite \> 48 hours of antibiotic treatment). 7\. Moribund subject or subject with severe or deteriorating damage in more than 3 critical body systems, based on investigator's clinical judgement.

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Conditions

The condition(s) this trial relates to.

congestive heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute decompensated heart failure

Contacts and locations

Locations

  • A.O.U Pisana Cisanello

    Pisa, Italy

  • CINRE, s.r.o.

    Bratislava, Slovakia

  • Heartcenter Dresden

    Dresden, Germany

  • Hospital Clínico Universitario de Valencia

    Valencia, Spain

  • Hospital clinic de Barcelona

    Barcelona, 08036, Spain

  • Klinikum Fürth

    Fürth, Germany

  • Mikulicz-Radecki University Teaching Hospital in Wrocław

    Wroclaw, 50-368, Poland

  • SUSCCH

    Banská Bystrica, Slovakia

  • UKSH Universitäres Herzzentrum Lübeck

    Lübeck, Germany

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, Germany

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