Overview

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.

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

        Systolic blood pressure < 80 mmHg at the time of screening. 2. Acute myocardial infarction
        or acute coronary syndrome or cardiogenic shock or pleurocentesis within past 14 days or
        cardiovascular intervention within past 14 days. 3. Complex congenital heart disease (e.g.,
        Tetralogy of Fallot subjects, single ventricle physiology).
        4. Known active myocarditis, hypertrophic obstructive cardiomyopathy, infiltrative
        cardiomyopathy (e.g., amyloidosis), constrictive pericarditis or cardiac tamponade.
        5. Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such
        as severe stenosis \severe regurgitation) or Severe mitral disease with planned
        intervention.
        6. Evidence of active systemic infection documented by either one of the following: fever
        >38°C/100°F, or ongoing uncontrolled infection (i.e., inflammatory parameters not
        decreasing despite > 48 hours of antibiotic treatment).
        7. Moribund subject or subject with severe or deteriorating damage in more than 3 critical
        body systems, based on investigator's clinical judgement.