Doraya Heart Failure Catheter Trial Announced
A feasibility study showed the device improved urine output in heart failure patients.
Updated on Oct. 10, 2026 in Heart Disease
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Developers have announced plans for a pivotal trial of the Doraya heart failure catheter. The recent feasibility study successfully met safety and efficacy goals across 16 patients.
Why it matters
The Doraya catheter is designed to reduce pressure in the renal venous system to improve patient decongestion. This technology could offer a new percutaneous approach to managing cardiac preload in heart failure patients.
In the feasibility study, urine output increased from 80 mL/hour at baseline to 224.1 mL/hour during device dwell. The study recorded zero device-related adverse events and one procedure-related event.
The players
DORAYA-HF
This is the clinical research study evaluating the safety and performance of the percutaneous heart failure catheter.
HFSA
The Heart Failure Society of America is a professional organization dedicated to the study and treatment of heart failure.
The details
The catheter is deployed percutaneously in the inferior vena cava transfemorally for 12 hours or less, where a distal frame opening partially obstructs venous flow. During the 2022 to 2024 study period, investigators noted that three patients required hospital readmission within 60 days.
Timeline
The DORAYA-HF feasibility study was conducted between 2022 and 2024.
Results were presented during the HFSA Annual Scientific Meeting from October 9-12, 2026.
A pivotal clinical trial is expected to begin in early 2027.
The Big Picture
This development follows the findings established by the DORAYA-HF feasibility study to justify the launch of a larger pivotal trial. The transition marks a standard progression in medical device validation as the technology moves toward potential regulatory review.
The Doraya catheter is an experimental device intended for hospital settings to improve decongestion in heart failure patients. Patients should note that this treatment remains in the clinical trial phase and is not yet available for general medical use.
The takeaway
The successful feasibility results provide a basis for future studies on this catheter-based approach to heart failure. Researchers will continue to monitor safety and efficacy as the device advances toward a pivotal clinical trial.
What happens next
A pivotal clinical trial for the Doraya heart failure catheter is scheduled to begin in early 2027.
Further reading
Learn more about the latest innovations in Heart Disease management and research.
More information
Review the full DORAYA-HF clinical trial information on the federal registry.
Source note: This article includes information reported by Hcplive.
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Would you feel comfortable using a new, minimally invasive device to treat chronic heart failure?
