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

DORAYA-HF EU: Assessment of the Doraya Catheter for the Treatment of Volume Overload in Acute Heart Failure Patients With Insufficient Response to Diuretics

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05876078

Enrollment

Registered

2023-05-25

Start date

2024-07-01

Completion date

2026-02-28

Last updated

2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Decompensated Heart Failure

Keywords

ADHF

Brief 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.

Interventions

DEVICEDoraya catheter

Temporary deployment of the Doraya catheter in ADHF patients

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Serious Adverse Events	30 day post Doraya procedure	Device or procedure related SAEs rate (including MACE) based on MM adjudication.
Urine Output	24 hours pre Doraya deployment, during Doraya indwelling period, and for 24 hours after Doraya removal	Change in total urine output

Countries

Germany, Italy, Poland, Slovakia, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026