DORAYA-HF Early Feasibility Study

DORAYA-HF: Assessment of the Doraya Catheter for the Treatment of Volume Overload in Acute Heart Failure Patients With Insufficient Response to Diuretics

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Decompensated Heart Failure
• Intervention / Treatment: Device: Doraya Catheter

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • UCSF
    • San Francisco, California, United States, 94110
      • Zuckerberg San Francisco General
    • San Francisco, California, United States, 94121
      • San Francisco VA
  • Florida
    • Weston, Florida, United States, 33331
      • Cleveland Clinic
  • Georgia
    • Augusta, Georgia, United States, 30901
      • Piedmont Hospital
    • Gainesville, Georgia, United States, 30501
      • Northeast Georgia Medical Center
  • Missouri
    • St Louis, Missouri, United States, 63136
      • Christian Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital
    • Cleveland, Ohio, United States, 44109
      • The MetroHealth System
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73135
      • Oklahoma Heart
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Prisma Health
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center
    • Houston, Texas, United States, 77030
      • CHI St. Luke's Health-Baylor St. Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

INCLUSION.

1. Subject is >18 years of age.
2. Subject is hospitalized with primary diagnosis of ADHF.
3. N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,000 pg/m or BNP≥250 pg/mL for body-mass index (BMI) ≤25.

4. Evidence of fluid overload as indicated by 2 or more of the following criteria:

   1. peripheral edema ≥ 2+
   2. radiographic pulmonary edema or pleural effusion
   3. enlarged liver or ascites
   4. pulmonary rales or paroxysmal nocturnal dyspnea, or orthopnea
   5. Jugular venous distention > 7 cmH2O
5. IVCCI < 50% by cardiac ultrasonography or elevated CVP (or RAP) ≥12 mmHg (Invasively measured).

6. Subject insufficiently responds to IV diuretic therapy defined as average hourly urine output <125ml/hour over 6 hours OR cumulative urine output < 3L over 24 hours OR a Net Fluid Loss <375mL in a 12-hour timeframe following ≥2 diuretic challenges with a minimum of:

   1. 1st diuretic dose: ≥2X chronic oral daily dose (IV) or 80 mg IV Lasix or equivalent.
   2. 2nd diuretic dose: ≥ 80 mg IV Lasix or equivalent.

7. Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study. Females of child-bearing potential must have a negative pregnancy test.

   Procedural Inclusion Criterion

8. CVP (or RAP) ≥12 mmHg and PCWP ≥ 18 mmHg confirmed in the Cath Lab, via femoral line, pigtail, Swan Ganz, or other indwelling catheter.

EXCLUSION

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. Known LVEF < 10% by echocardiography within 1 year prior to enrollment.
4. Complex congenital heart disease (e.g., Tetralogy of Fallot subjects, single ventricle physiology).
5. Known active myocarditis, hypertrophic obstructive cardiomyopathy, infiltrative cardiomyopathy (e.g., amyloidosis), constrictive pericarditis or cardiac tamponade.
6. Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such as severe stenosis \severe regurgitation) or Severe mitral disease with planned intervention.
7. Subject has severe renal dysfunction, defined as either eGFR <25 ml/min/1.73 m2 BSA on admission or on renal replacement therapy.
8. Subject with advanced liver disease: either Total Bilirubin > 4 mg/dL or Serum sodium (corrected for glucose) < 125 mmol/L.
9. Treatment with high dose IV inotropes within 2 days prior to enrollment. High dose is defined as > 1 unit of inotrope (excluding Digoxin) as follows: 5 µg/kg/min dopamine = 1 unit, 5 µg/kg/min dobutamine= 1 unit, 0.375 µg/kg/min milrinone = 1 unit.

10. Subject with a history of:

    1. Deep vein thrombosis that occurred < 6 months prior to enrollment, and/or;
    2. Pulmonary embolism episode that occurred < 6 months prior to enrollment.
11. 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 hrs of antibiotic treatment).
12. Subjects with a known infra-renal IVC diameter of <16mm.
13. Moribund subject or subject with severe or deteriorating damage in more than 3 critical body systems, based on investigator's clinical judgement.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm; Diuretics only
Experimental: Doraya Catheter; Doraya Catheter with diuretics	Device: Doraya Catheter; The Doraya Catheter is a temporary intravenous flow regulator, positioned in the inferior vena cava below the level of the renal veins

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious Adverse Events	Device or procedure related SAEs rate (including MACE) based on CEC adjudication.	30 days
Urine Output	Change in rate of urine output	baseline [pre intervention] and accumulated through 24 hours [T=0-24 hours]

Collaborators and Investigators

• Sponsor: Revamp Medical Inc.
• Investigators: Study Director: Mike Favet, CEO

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2022
• Primary Completion (Actual): January 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: December 28, 2021
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: ADHF
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: CIS-D-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No