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

Acute Decompensated Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05876078
• Other study ID #: CIS-D-04
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: December 2023
• Source: Revamp Medical Ltd.
• Contact: Sahar Boostenay
• Phone: +972544621243
• Email: Saharb[@]revampmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: April 30, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Heart Failure

Intervention

Device:
• Doraya catheter
Temporary deployment of the Doraya catheter in ADHF patients

Locations

Country	Name	City	State
Georgia	LLC "Aleksandre Aladashvili clinic"	Tbilisi
Georgia	LLC Bokhua Memorial Cardiovascular Center	Tbilisi
Georgia	LTD Israel Georgian Medical Research Clinic Helsicore	Tbilisi
Poland	Mikulicz-Radecki University Teaching Hospital in Wroclaw	Wroclaw
Spain	Hospital clinic de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Revamp Medical Ltd.

Countries where clinical trial is conducted

Georgia,  Poland,  Spain, 

Outcome

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