Doraya Catheter / Acute Decompensated Heart Failure · Interventional Study

DORAYA-HF Early Feasibility Study

ClinicalTrials.gov · August 13, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a completed early feasibility study of the Doraya Catheter in 21 patients with acute decompensated heart failure refractory to diuretics. Results are not posted in this registry record, so no efficacy or safety data can be evaluated. The study was designed to assess safety, serious adverse events at 30 days, and urine output response.

What was studied

Interventional, Randomized, Parallel, Open label, Treatment purpose. Acute Decompensated Heart Failure; age from 18 Years. Intervention: Doraya Catheter. Compared with: Control Arm — No Intervention. n = 21. 14 sites: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

Clinicians and researchers cannot draw clinical conclusions from this registry record alone, as results are not posted. Once outcomes are published, this early feasibility data may inform design of larger trials, but cannot yet support clinical adoption.

Plain-language summary

Early feasibility study of a novel device in 21 patients with acute decompensated heart failure; recruitment completed but no results reported in this registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Serious Adverse Events (assessed at 30 days); Urine Output (assessed at baseline [pre intervention] and accumulated through 24 hours [T=0-24 hours])

DesignInterventional, Randomized, Parallel, Open label, Treatment purpose

PopulationAcute Decompensated Heart Failure; age from 18 Years

Sample size21

InterventionDoraya Catheter

ComparatorControl Arm — No Intervention

Setting14 sites: United States

Reported figures

Quoted from the source exactly as published.

Planned sample size21

Primary outcome measure 1Serious Adverse Events at 30 days

Primary outcome measure 2Urine Output (baseline and accumulated through 24 hours)

Clinical bottom line

Caveats

Results are not posted in this registry record; no outcome data available for review
Single-arm design without control group limits causal inference
Early feasibility phase typically underpowered to detect efficacy differences
No published results referenced; follow-up in peer-reviewed literature needed

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Single-arm early feasibility design with no comparator group

Directness

moderate

Directly addresses the target population and intervention; safety and feasibility endpoints are appropriate

Consistency

insufficient

No results reported; cannot assess consistency with other evidence

Risk of bias

limited

Uncontrolled design inherently limits ability to attribute outcomes to intervention

Sample adequacy

limited

N=21 is appropriate for early feasibility but insufficient for efficacy claims

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05206422). This is a study registration, not published results. Lead sponsor: Revamp Medical Inc.. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 21 participants (ACTUAL). Conditions: Acute Decompensated Heart Failure. Interventions: DEVICE: Doraya Catheter. Primary outcome measures: Serious Adverse Events , 30 days; Urine Output , baseline [pre intervention] and accumulated through 24 hours [T=0-24 hours]. Brief 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Doraya CatheterAcute Decompensated Heart FailureRevamp MedicalNCT05206422