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

NCT05876078 | Completed FDA Device

• 1 other identifier: CIS-D-04
• Study Type: interventional
• Target: 25
• Locations: 5 countries
• Sites: 10

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.

Conditions

Acute Decompensated Heart Failure

Keywords

ADHF

Outcome Measures

Primary Outcomes (2)

• Serious Adverse Events

  Device or procedure related SAEs rate (including MACE) based on MM adjudication.

  30 day post Doraya procedure

• Urine Output

  Change in total urine output

  24 hours pre Doraya deployment, during Doraya indwelling period, and for 24 hours after Doraya removal

Study Arms (1)

ADHF patients

EXPERIMENTAL

ADHF patients with insufficient response to diuretics treated with the Doraya catheter

Device: Doraya catheter

Interventions

Doraya catheter DEVICE

Temporary deployment of the Doraya catheter in ADHF patients

ADHF patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is hospitalized with primary diagnosis of ADHF.
• N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,000 pg/m orvBNP≥250 pg/mL.
• Evidence of fluid overload.
• Subject insufficiently responds to IV diuretic therapy

You may not qualify if:

• 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).
• \. Known active myocarditis, hypertrophic obstructive cardiomyopathy, infiltrative cardiomyopathy (e.g., amyloidosis), constrictive pericarditis or cardiac tamponade.
• \. Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such as severe stenosis \\severe regurgitation) or Severe mitral disease with planned intervention.
• \. 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).
• \. Moribund subject or subject with severe or deteriorating damage in more than 3 critical body systems, based on investigator's clinical judgement.

Sponsors & Collaborators

• Revamp Medical Ltd.: lead

Study Sites (10)

Heartcenter Dresden

Dresden, Germany

Location

Klinikum Fürth

Fürth, Germany

Location

UKSH Universitäres Herzzentrum Lübeck

Lübeck, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, Germany

Location

A.O.U Pisana Cisanello

Pisa, Italy

Location

Mikulicz-Radecki University Teaching Hospital in Wrocław

Wroclaw, 50-368, Poland

Location

SUSCCH

Banská Bystrica, Slovakia

Location

CINRE, s.r.o.

Bratislava, Slovakia

Location

Hospital clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 25, 2023
• Study Start: July 1, 2024
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

DE (4); PL (1); SL (2); ES (2); IT (1)