The MetroHealth System

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

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

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

Arm	Description	Assigned 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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.