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.
Conditions:
🦠 Acute Decompensated Heart Failure
🗓️ Study Start (Actual) 5 October 2022
🗓️ Primary Completion (Estimated) December 2024
✅ Study Completion (Estimated) March 2025
👥 Enrollment (Estimated) 30
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 San Francisco, California, United States
📍 San Francisco, California, United States
📍 San Francisco, California, United States
📍 Weston, Florida, United States
📍 Detroit, Michigan, United States
📍 Saint Louis, Missouri, United States
📍 Las Vegas, Nevada, United States
📍 Cincinnati, Ohio, United States
📍 Cleveland, Ohio, United States
📍 Columbus, Ohio, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

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

    Exclusion Criteria:

    • 1. Systolic blood pressure \< 90 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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 28 December 2021
  • First Submitted that Met QC Criteria 11 January 2022
  • First Posted 25 January 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 15 May 2024
  • Last Update Posted 16 May 2024
  • Last Verified May 2024