DORAYA-HF Early Feasibility Study

Purpose

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.

Condition

  • Acute Decompensated Heart Failure

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ADHF patients 		ADHF patients with insufficient response to diuretics treated with the Doraya catheter
  • Device: Doraya catheter
    Temporary deployment of the Doraya catheter in ADHF patients

Recruiting Locations

The MetroHealth System
Cleveland, Ohio 44109
Contact:
Peter Leo

More Details

Status
Recruiting
Sponsor
Revamp Medical Inc.

Study Contact

Sahar Boostenay
+972544621243
Saharb@revampmedical.com