AzTrials
AzTrials

Acute Decompensated Heart FailureNCT05206422

DORAYA-HF Early Feasibility Study

A study testing Doraya Catheter in people with Acute Decompensated Heart Failure, run by Revamp Medical Inc. at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Decompensated Heart Failure
What is being tested?
Doraya Catheter
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
14 sitesUnited States
Study dates
5 Oct 2022to 31 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is >18 years of age.
  • 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 for body-mass index (BMI) ≤25.
  • Evidence of fluid overload as indicated by 2 or more of the following criteria:
  • peripheral edema ≥ 2+
  • radiographic pulmonary edema or pleural effusion
Show all 16Show fewer
  • enlarged liver or ascites
  • pulmonary rales or paroxysmal nocturnal dyspnea, or orthopnea
  • Jugular venous distention > 7 cmH2O
  • IVCCI < 50% by cardiac ultrasonography or elevated CVP (or RAP) ≥12 mmHg (Invasively measured).
  • 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:
  • 1st diuretic dose: ≥2X chronic oral daily dose (IV) or 80 mg IV Lasix or equivalent.
  • 2nd diuretic dose: ≥ 80 mg IV Lasix or equivalent.
  • 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
  • CVP (or RAP) ≥12 mmHg and PCWP ≥ 18 mmHg confirmed in the Cath Lab, via femoral line, pigtail, Swan Ganz, or other indwelling catheter.

Who cannot join

  • 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.
  • Known LVEF < 10% by echocardiography within 1 year prior to enrollment.
  • 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.
Show all 15Show fewer
  • Subject has severe renal dysfunction, defined as either eGFR <25 ml/min/1.73 m2 BSA on admission or on renal replacement therapy.
  • Subject with advanced liver disease: either Total Bilirubin > 4 mg/dL or Serum sodium (corrected for glucose) < 125 mmol/L.
  • 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.
  • Subject with a history of:
  • Deep vein thrombosis that occurred < 6 months prior to enrollment, and/or;
  • Pulmonary embolism episode that occurred < 6 months prior to enrollment.
  • 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).
  • Subjects with a known infra-renal IVC diameter of <16mm.
  • Moribund subject or subject with severe or deteriorating damage in more than 3 critical body systems, based on investigator's clinical judgement.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Piedmont Hospital

    Augusta, Georgia, 30901

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • The MetroHealth System

    Cleveland, Ohio, 44109

  • Prisma Health

    Columbia, South Carolina, 29203

  • The Ohio State University

    Columbus, Ohio, 43210

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • CHI St. Luke's Health-Baylor St. Luke's Medical Center

    Houston, Texas, 77030

  • Oklahoma Heart

    Oklahoma City, Oklahoma, 73135

  • Zuckerberg San Francisco General

    San Francisco, California, 94110

  • San Francisco VA

    San Francisco, California, 94121

  • UCSF

    San Francisco, California, 94143

  • Christian Hospital

    St Louis, Missouri, 63136

  • Cleveland Clinic

    Weston, Florida, 33331

Other trials in United States

About this 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

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.

Being tested
Doraya Catheter
Keywords
ADHF

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Doraya CatheterDevice

    The Doraya Catheter is a temporary intravenous flow regulator, positioned in the inferior vena cava below the level of the renal veins

Study groups in NCT05206422
Study groupRoleWhat they receive
Control ArmNo interventionDiuretics only
Doraya CatheterExperimentalDoraya Catheter with diuretics
Receives: Device: Doraya Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serious Adverse Events

    Device or procedure related SAEs rate (including MACE) based on CEC adjudication.

    Measured: 30 days

  2. Urine Output

    Change in rate of urine output

    Measured: baseline [pre intervention] and accumulated through 24 hours [T=0-24 hours]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2022
  2. Study start5 Oct 2022
  3. Primary completion31 Jan 2026
  4. Study completion31 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05206422
Sponsor's protocol ID
CIS-D-03
Status last verified
Oct 2025
First submitted
28 Dec 2021
Last updated
13 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Doraya Catheter in people with Acute Decompensated Heart Failure, run by Revamp Medical Inc. at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serious Adverse Events (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05206422.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in