Heart Failure Clinical Trial
DORAYA-HF Early Feasibility Study
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.
Subject is hospitalized with primary diagnosis of ADHF.
N-terminal-pro-brain natriuretic peptide (NT-proBNP) â‰¥1,000 pg/m or BNPâ‰¥250 pg/mL.
Evidence of fluid overload.
Subject insufficiently responds to IV diuretic therapy
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.
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.
Evidence of active systemic infection documented by either one of the following: fever >38Â°C/100Â°F, or ongoing uncontrolled infection (i.e., inflammatory parameters not decreasing despite > 48 hours of antibiotic treatment).
Moribund subject or subject with severe or deteriorating damage in more than 3 critical body systems, based on investigator's clinical judgement.
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There are 7 Locations for this study
Saint Louis Missouri, 63136, United States More Info
Cincinnati Ohio, 45219, United States More Info
Cleveland Ohio, 44195, United States More Info
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