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DORAYA-HF Early Feasibility Study

NCT05206422 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-08-13

No results posted yet for this study

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

The Doraya Catheter is a temporary intravenous flow regulator, positioned in the inferior vena cava below the level of the renal veins

Sponsors & Collaborators

  • Revamp Medical Inc.

    lead INDUSTRY

Principal Investigators

  • Mike Favet · CEO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-05
Primary Completion
2026-01-31
Completion
2026-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05206422 on ClinicalTrials.gov