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

Not Applicable

Recruiting

• Conditions: Acute Decompensated Heart Failure
• Interventions: Device: Doraya catheter

• Registration Number: NCT05876078
• Lead Sponsor: Revamp Medical Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-16
• Study First Submitted QC: 2023-05-16
• Study First Posted: 2023-05-25
• Study Start: 2024-07-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-17
• Primary Completion: 2025-12-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ADHF patients	Doraya catheter	ADHF patients with insufficient response to diuretics treated with the Doraya catheter

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

Narodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego Państwowy Instytut Badawczy; 🇵🇱 Warsaw, Poland

SUSCCH; 🇸🇰 Banská Bystrica, Slovakia

CINRE, s.r.o.; 🇸🇰 Bratislava, Slovakia

LLC Bokhua Memorial Cardiovascular Center; 🇬🇪 Tbilisi, Georgia

LTD Israel Georgian Medical Research Clinic Helsicore; 🇬🇪 Tbilisi, Georgia

Mikulicz-Radecki University Teaching Hospital in Wrocław; 🇵🇱 Wrocław, Poland

Hospital clinic de Barcelona; 🇪🇸 Barcelona, Spain