Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Lucas Zier, MDLiviu Klein, M.D.
Headshot of Liviu Klein
Liviu Klein

Description

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.

Official Title

DORAYA-HF: Assessment of the Doraya Catheter for the Treatment of Volume Overload in Acute Heart Failure Patients With Insufficient Response to Diuretics

Keywords

Acute Decompensated Heart Failure, ADHF, Heart Failure, Doraya catheter

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  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.

Locations

  • Zuckerberg San Francisco General accepting new patients
    San Francisco California 94110 United States
  • UCSF accepting new patients
    San Francisco California 94143 United States
  • San Francisco VA accepting new patients
    San Francisco California 94121 United States

Lead Scientists at UCSF

  • Lucas Zier, MD
    Associate Professor, Medicine, School of Medicine. Authored (or co-authored) 24 research publications
  • Liviu Klein, M.D.
    My are heart failure and cardiac arrhythmias in patients with heart failure. Having advanced training in both heart failure and electrophysiology, I practice an integrated approach in treating patients with heart failure and cardiac arrhythmias. I am also interested in cardiac recovery using electrical (i.e. cardiac resynchronization) and mechanical (i.e. ventricular assist devices) therapies.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Revamp Medical Inc.
ID
NCT05206422
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated