DORAYA-HF Early Feasibility Study

Description

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

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Study Overview

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Study Details

Study 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.

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

DORAYA-HF Early Feasibility Study

Condition
Acute Decompensated Heart Failure
Intervention / Treatment

-

Contacts and Locations

San Francisco

Zuckerberg San Francisco General, San Francisco, California, United States, 94110

San Francisco

San Francisco VA, San Francisco, California, United States, 94121

San Francisco

UCSF, San Francisco, California, United States, 94143

Weston

Cleveland Clinic, Weston, Florida, United States, 33331

Detroit

Henry Ford, Detroit, Michigan, United States, 48202

Saint Louis

Christian Hospital, Saint Louis, Missouri, United States, 63136

Las Vegas

UMC of Southern Nevada, Las Vegas, Nevada, United States, 89102

Cincinnati

The Christ Hospital, Cincinnati, Ohio, United States, 45219

Cleveland

The MetroHealth System, Cleveland, Ohio, United States, 44109

Columbus

The Ohio State University, Columbus, Ohio, United States, 43210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Revamp Medical Inc.,

Yael Shohat, STUDY_DIRECTOR, CEO

Study Record Dates

2025-03