DORAYA-HF OUS Assessment of the Doraya Catheter for the Treatment of ADHF Patients With Insufficient Response to Diuretics
NCT05876078 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2026-03-09
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.
Conditions
- Acute Decompensated Heart Failure
Interventions
- DEVICE
-
Doraya catheter
Temporary deployment of the Doraya catheter in ADHF patients
Sponsors & Collaborators
-
Revamp Medical Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-01
- Primary Completion
- 2026-02-28
- Completion
- 2026-02-28
- FDA Device
- Yes
Countries
- Germany
- Italy
- Poland
- Slovakia
- Spain
Study Locations
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