CompletedNot Applicable

DORAYA-HF OUS Assessment of the Doraya Catheter for the Treatment of ADHF Patients With Insufficient Response to Diuretics

Germany, Italy25 participantsStarted 2024-07-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Subject is hospitalized with primary diagnosis of ADHF.
✓. N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,000 pg/m orvBNP≥250 pg/mL.
✓. Evidence of fluid overload.
✓. Subject insufficiently responds to IV diuretic therapy

What they're measuring

Serious Adverse Events

Timeframe: 30 day post Doraya procedure

Urine Output

Timeframe: 24 hours pre Doraya deployment, during Doraya indwelling period, and for 24 hours after Doraya removal

Trial details

NCT IDNCT05876078

SponsorRevamp Medical Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02-28

View on ClinicalTrials.gov More Acute Decompensated Heart Failure trials