Back to resultsDORAYA-HF Early Feasibility Study
Primary Purpose
Acute Decompensated Heart Failure
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Doraya catheter
Sponsored by
About this trial
This is an interventional treatment trial for Acute Decompensated Heart Failure focused on measuring ADHF
Eligibility Criteria
Inclusion Criteria:
- Subject is hospitalized with primary diagnosis of ADHF.
- N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,600 pg/m or BNP≥400 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.
Sites / Locations
- Zuckerberg San Francisco GeneralRecruiting
- San Francisco VARecruiting
- UCSFRecruiting
- Henry FordRecruiting
- Christian Hospital
- UMC of Southern Nevada
- The Christ HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ADHF patients
Arm Description
ADHF patients with insufficient response to diuretics treated with the Doraya catheter
Outcomes
Primary Outcome Measures
Serious Adverse Events
Device or procedure related SAEs rate (including MACE) based on CEC adjudication.
Urine Output
Change in rate of urine output
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05206422
Brief Title
DORAYA-HF Early Feasibility Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Revamp Medical Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Decompensated Heart Failure
Keywords
ADHF
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ADHF patients
Arm Type
Experimental
Arm Description
ADHF patients with insufficient response to diuretics treated with the Doraya catheter
Intervention Type
Device
Intervention Name(s)
Doraya catheter
Intervention Description
Temporary deployment of the Doraya catheter in ADHF patients
Primary Outcome Measure Information:
Title
Serious Adverse Events
Description
Device or procedure related SAEs rate (including MACE) based on CEC adjudication.
Time Frame
30 days
Title
Urine Output
Description
Change in rate of urine output
Time Frame
baseline [pre intervention] and accumulated through 24 hours [T=0-24 hours]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sahar Boostenay
Phone
+972544621243
Email
Saharb@revampmedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yael Shohat
Phone
+972526384749
Email
Yaels@revampmedical.com
Facility Information:
Facility Name
Zuckerberg San Francisco General
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Steineman
First Name & Middle Initial & Last Name & Degree
Lucas Zier, MD
Facility Name
San Francisco VA
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Huynh
First Name & Middle Initial & Last Name & Degree
Joseph Yang, MD
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Priscilla Zhang
First Name & Middle Initial & Last Name & Degree
Liviu Klein, M.D.
Facility Name
Henry Ford
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelsey Neaton
Email
kneaton1@hfhs.org
First Name & Middle Initial & Last Name & Degree
Gillian Grafton, MD
Facility Name
Christian Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Individual Site Status
Terminated
Facility Name
UMC of Southern Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Robinson, CCRC
First Name & Middle Initial & Last Name & Degree
Chowdhury Ahsan, MD
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wendy Parker
First Name & Middle Initial & Last Name & Degree
Eugene Chung, MD
First Name & Middle Initial & Last Name & Degree
Ankit Bhatia, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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