DORAYA-HF Early Feasibility Study

Acute Decompensated Heart Failure Clinical Trial

Official title:

DORAYA-HF: 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: NCT05206422
• Other study ID #: CIS-D-03
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2022
• Est. completion date: March 2025

Study information

• Verified date: May 2024
• 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: 30
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• 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 or BNP=250 pg/mL.

3. Evidence of fluid overload.

4. Subject insufficiently responds to IV diuretic therapy

Exclusion Criteria:

1. Systolic blood pressure < 90 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
United States	The Christ Hospital	Cincinnati	Ohio
United States	The MetroHealth System	Cleveland	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Henry Ford	Detroit	Michigan
United States	UMC of Southern Nevada	Las Vegas	Nevada
United States	Christian Hospital	Saint Louis	Missouri
United States	San Francisco VA	San Francisco	California
United States	UCSF	San Francisco	California
United States	Zuckerberg San Francisco General	San Francisco	California
United States	Cleveland Clinic	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Revamp Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious Adverse Events	Device or procedure related SAEs rate (including MACE) based on CEC adjudication.	30 days
Primary	Urine Output	Change in rate of urine output	baseline [pre intervention] and accumulated through 24 hours [T=0-24 hours]