RECRUITING

DORAYA-HF Early Feasibility Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2022-10-05

Study Completion:2025-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05206422

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Sahar Boostenay

CONTACT

+972544621243

Saharb@revampmedical.com

Principal Investigator

Yael Shohat

STUDY_DIRECTOR

CEO

Study Locations (Sites)

Zuckerberg San Francisco General

San Francisco, California, 94110

United States

San Francisco VA

San Francisco, California, 94121

United States

UCSF

San Francisco, California, 94143

United States

Cleveland Clinic

Weston, Florida, 33331

United States

Henry Ford

Detroit, Michigan, 48202

United States

Christian Hospital

Saint Louis, Missouri, 63136

United States

UMC of Southern Nevada

Las Vegas, Nevada, 89102

United States

The Christ Hospital

Cincinnati, Ohio, 45219

United States

The MetroHealth System

Cleveland, Ohio, 44109

United States

The Ohio State University

Columbus, Ohio, 43210

United States

Collaborators and Investigators

Sponsor: Revamp Medical Inc.

Yael Shohat, STUDY_DIRECTOR, CEO

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-05

Study Completion Date2025-03

Study Record Updates

Study Start Date2022-10-05

Study Completion Date2025-03

Terms related to this study

Keywords Provided by Researchers

ADHF

Additional Relevant MeSH Terms

Acute Decompensated Heart Failure