DORAYA-HF OUS Assessment of the Doraya Catheter for the Treatment of ADHF Patients With Insufficient Response to Diuretics

Last updated: June 25, 2025
Sponsor: Revamp Medical Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hyponatremia

Congestive Heart Failure

Heart Failure

Treatment

Doraya catheter

Clinical Study ID

NCT05876078
CIS-D-04
  • Ages > 18
  • All Genders

Study Summary

The study objective is to evaluate the feasibility of the Doraya Catheter and measure clinical performance and safety endpoints, in ADHF patients deemed to have insufficient diuretic response.

Eligibility Criteria

Inclusion

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

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).

  1. Known active myocarditis, hypertrophic obstructive cardiomyopathy, infiltrativecardiomyopathy (e.g., amyloidosis), constrictive pericarditis or cardiac tamponade.

  2. Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseasessuch as severe stenosis \severe regurgitation) or Severe mitral disease with plannedintervention.

  3. Evidence of active systemic infection documented by either one of the following:fever >38°C/100°F, or ongoing uncontrolled infection (i.e., inflammatory parametersnot decreasing despite > 48 hours of antibiotic treatment).

  4. Moribund subject or subject with severe or deteriorating damage in more than 3critical body systems, based on investigator's clinical judgement.

Study Design

Total Participants: 35
Treatment Group(s): 1
Primary Treatment: Doraya catheter
Phase:
Study Start date:
July 01, 2024
Estimated Completion Date:
April 30, 2026

Connect with a study center

  • LLC "Aleksandre Aladashvili clinic"

    Tbilisi,
    Georgia

    Active - Recruiting

  • LLC "American Hospital Network"

    Tbilisi,
    Georgia

    Site Not Available

  • LLC Bokhua Memorial Cardiovascular Center

    Tbilisi,
    Georgia

    Site Not Available

  • LTD Israel Georgian Medical Research Clinic Helsicore

    Tbilisi,
    Georgia

    Site Not Available

  • Heartcenter Dresden

    Dresden,
    Germany

    Active - Recruiting

  • Klinikum Fürth

    Fürth,
    Germany

    Active - Recruiting

  • UKSH Universitäres Herzzentrum Lübeck

    Lübeck,
    Germany

    Active - Recruiting

  • Narodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego Państwowy Instytut Badawczy

    Warsaw,
    Poland

    Site Not Available

  • Mikulicz-Radecki University Teaching Hospital in Wrocław

    Wrocław, 50-368
    Poland

    Active - Recruiting

  • SUSCCH

    Banská Bystrica,
    Slovakia

    Active - Recruiting

  • CINRE, s.r.o.

    Bratislava,
    Slovakia

    Active - Recruiting

  • Hospital clinic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Vall d'Hebron University Hospital

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valencia

    Valencia,
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valladolid

    Valladolid,
    Spain

    Active - Recruiting

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