DORAYA-HF Early Feasibility Study
- Conditions
- Acute Decompensated Heart Failure
- Interventions
- Device: Doraya catheter
- Registration Number
- NCT05206422
- Lead Sponsor
- Revamp Medical Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ADHF patients Doraya catheter ADHF patients with insufficient response to diuretics treated with the Doraya catheter
- Primary Outcome Measures
Name Time Method Serious Adverse Events 30 days Device or procedure related SAEs rate (including MACE) based on CEC adjudication.
Urine Output baseline [pre intervention] and accumulated through 24 hours [T=0-24 hours] Change in rate of urine output
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Zuckerberg San Francisco General
🇺🇸San Francisco, California, United States
San Francisco VA
🇺🇸San Francisco, California, United States
UCSF
🇺🇸San Francisco, California, United States
Cleveland Clinic
🇺🇸Weston, Florida, United States
Henry Ford
🇺🇸Detroit, Michigan, United States
Christian Hospital
🇺🇸Saint Louis, Missouri, United States
UMC of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
The MetroHealth System
🇺🇸Cleveland, Ohio, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Oklahoma Heart
🇺🇸Oklahoma City, Oklahoma, United States