Heart Failure Clinical Trial

DORAYA-HF Early Feasibility Study

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Systolic blood pressure < 90 mmHg at the time of screening.
Acute myocardial infarction or acute coronary syndrome or cardiogenic shock or pleurocentesis within past 14 days or cardiovascular intervention within past 14 days.
Complex congenital heart disease (e.g., Tetralogy of Fallot subjects, single ventricle physiology).
Known active myocarditis, hypertrophic obstructive cardiomyopathy, infiltrative cardiomyopathy (e.g., amyloidosis), constrictive pericarditis or cardiac tamponade.
Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such as severe stenosis severe regurgitation) or Severe mitral disease with planned intervention.
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).
Moribund subject or subject with severe or deteriorating damage in more than 3 critical body systems, based on investigator's clinical judgement.

Study is for people with:

Heart Failure

Estimated Enrollment:

15

Study ID:

NCT05206422

Recruitment Status:

Recruiting

Sponsor:

Revamp Medical Inc.

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There are 7 Locations for this study

See Locations Near You

UnityPoint Health
Davenport Iowa, 52807, United States More Info
Lori Christensen, RN, BSN
Contact
563-324-2828
Nicolas Shammas
Principal Investigator
Henry Ford
Detroit Michigan, 48202, United States More Info
Kelsey Neaton
Contact
[email protected]
Gillian Grafton, MD
Principal Investigator
Christian Hospital
Saint Louis Missouri, 63136, United States More Info
Paige Brown
Contact
Gil Vardi, Dr.
Principal Investigator
Columbia University Irving Medical Center
New York New York, 10032, United States More Info
Lauren Privitera
Contact
[email protected]
Gabriel Sayer, MD
Principal Investigator
Justin Fried, MD
Sub-Investigator
Montefiore Medical Center - Moses Campus
New York New York, 10461, United States More Info
Julio Ramos, Dr.
Contact
[email protected]
Daniel Sims, MD
Principal Investigator
Sandhya Murthy, MD
Sub-Investigator
The Christ Hospital
Cincinnati Ohio, 45219, United States More Info
Wendy Parker
Contact
Eugene Chung, MD
Principal Investigator
Ankit Bhatia, MD
Sub-Investigator
Cleveland Clinic
Cleveland Ohio, 44195, United States More Info
Teresa Fonk
Contact
Andrew Higgins, MD
Principal Investigator
Wilson Tang, MD
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

15

Study ID:

NCT05206422

Recruitment Status:

Recruiting

Sponsor:


Revamp Medical Inc.

How clear is this clinincal trial information?

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