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Device

Doraya Catheter for Heart Failure

N/A
Recruiting
Research Sponsored by Revamp Medical Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is hospitalized with primary diagnosis of ADHF
Subject insufficiently responds to IV diuretic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline [pre intervention] and accumulated through 24 hours [t=0-24 hours]
Awards & highlights

Study Summary

This trial is testing a new type of catheter to see if it is safe and effective for people with heart failure who haven't responded well to other treatments.

Who is the study for?
This trial is for hospitalized patients with acute decompensated heart failure (ADHF) who aren't responding well to IV diuretics. They must have fluid overload and high levels of certain heart-related biomarkers. It's not for those with very low blood pressure, recent heart attacks or interventions, complex congenital heart disease, severe valve disorders, active infections, or critical damage in multiple body systems.Check my eligibility
What is being tested?
The DORAYA-HF study is testing the Doraya Catheter's ability to manage fluid overload in ADHF patients who don't respond adequately to standard diuretic therapy. The goal is to assess how feasible and safe this catheter is when used in a real-world clinical setting.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include complications related to catheter insertion such as bleeding or infection at the site of entry, discomfort during the procedure, and any unforeseen reactions related to the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am in the hospital because of acute heart failure.
Select...
IV diuretics do not work well for me.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline [pre intervention] and accumulated through 24 hours [t=0-24 hours]
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline [pre intervention] and accumulated through 24 hours [t=0-24 hours] for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Serious Adverse Events
Urine Output

Trial Design

1Treatment groups
Experimental Treatment
Group I: ADHF patientsExperimental Treatment1 Intervention
ADHF patients with insufficient response to diuretics treated with the Doraya catheter
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doraya catheter
2018
N/A
~10

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for heart failure include diuretics, which reduce fluid overload by promoting urine production; ACE inhibitors and ARBs, which lower blood pressure and reduce strain on the heart by inhibiting the renin-angiotensin system; and beta-blockers, which decrease heart rate and improve heart function. Devices like the Doraya Catheter modulate renal perfusion or venous return to manage fluid overload, directly addressing one of the primary symptoms of heart failure. These treatments are essential as they help alleviate symptoms, prevent hospitalizations, and improve survival rates in heart failure patients.

Find a Location

Who is running the clinical trial?

Revamp Medical Inc.Lead Sponsor
Yael ShohatStudy DirectorCEO

Media Library

Doraya catheter (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05206422 — N/A
Heart Failure Research Study Groups: ADHF patients
Heart Failure Clinical Trial 2023: Doraya catheter Highlights & Side Effects. Trial Name: NCT05206422 — N/A
Doraya catheter (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05206422 — N/A
~6 spots leftby Dec 2024