Trials / Active Not Recruiting
Active Not RecruitingNCT05206422
DORAYA-HF Early Feasibility Study
DORAYA-HF: Assessment of the Doraya Catheter for the Treatment of Volume Overload in Acute Heart Failure Patients With Insufficient Response to Diuretics
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Revamp Medical Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2022-10-05
- Primary completion
- 2026-01-31
- Completion
- 2026-03-31
- First posted
- 2022-01-25
- Last updated
- 2026-03-09
Locations
14 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05206422. Inclusion in this directory is not an endorsement.