Active — Not RecruitingNot Applicable

DORAYA-HF Early Feasibility Study

United States30 participantsStarted 2022-10-05

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 \>18 years of age.
✓. Subject is hospitalized with primary diagnosis of ADHF.
✓. N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,000 pg/m or BNP≥250 pg/mL for body-mass index (BMI) ≤25.
✓. Evidence of fluid overload as indicated by 2 or more of the following criteria:
✓. peripheral edema ≥ 2+
✓. radiographic pulmonary edema or pleural effusion
✓. enlarged liver or ascites
✓. pulmonary rales or paroxysmal nocturnal dyspnea, or orthopnea

Exclusion criteria

✕. Systolic blood pressure \<90 mmHg at the time of screening.
✕. Acute myocardial infarction or acute coronary syndrome or cardiogenic shock or pleurocentesis within past 14 days or cardiovascular intervention within past 14 days.
✕. Known LVEF \< 10% by echocardiography within 1 year prior to enrollment.
✕. Complex congenital heart disease (e.g., Tetralogy of Fallot subjects, single ventricle physiology).
✕. Known active myocarditis, hypertrophic obstructive cardiomyopathy, infiltrative cardiomyopathy (e.g., amyloidosis), constrictive pericarditis or cardiac tamponade.
✕. Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such as severe stenosis \\severe regurgitation) or Severe mitral disease with planned intervention.
✕. Subject has severe renal dysfunction, defined as either eGFR \<25 ml/min/1.73 m2 BSA on admission or on renal replacement therapy.
✕. Subject with advanced liver disease: either Total Bilirubin \> 4 mg/dL or Serum sodium (corrected for glucose) \< 125 mmol/L.

What they're measuring

Serious Adverse Events

Timeframe: 30 days

Urine Output

Timeframe: baseline [pre intervention] and accumulated through 24 hours [T=0-24 hours]

Trial details

NCT IDNCT05206422

SponsorRevamp Medical Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-31

View on ClinicalTrials.gov More Acute Decompensated Heart Failure trials