NCT05206422

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

14 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

October 5, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

March 9, 2026

Status Verified

October 1, 2025

Enrollment Period

3.3 years

First QC Date

December 28, 2021

Last Update Submit

March 6, 2026

Conditions

Acute Decompensated Heart Failure

Keywords

ADHF

Outcome Measures

Primary Outcomes (2)

  • 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]

Study Arms (2)

Control Arm

NO INTERVENTION

Diuretics only

Doraya Catheter

EXPERIMENTAL

Doraya Catheter with diuretics

Device: Doraya Catheter

Interventions

Doraya CatheterDEVICE

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

Doraya Catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Zuckerberg San Francisco General

San Francisco, California, 94110, United States

Location

San Francisco VA

San Francisco, California, 94121, United States

Location

UCSF

San Francisco, California, 94143, United States

Location

Cleveland Clinic

Weston, Florida, 33331, United States

Location

Piedmont Hospital

Augusta, Georgia, 30901, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Christian Hospital

St Louis, Missouri, 63136, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

The MetroHealth System

Cleveland, Ohio, 44109, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Oklahoma Heart

Oklahoma City, Oklahoma, 73135, United States

Location

Prisma Health

Columbia, South Carolina, 29203, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

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

Houston, Texas, 77030, United States

Location

Study Officials

  • Mike Favet

    CEO

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2021

First Posted

January 25, 2022

Study Start

October 5, 2022

Primary Completion

January 31, 2026

Study Completion

March 31, 2026

Last Updated

March 9, 2026

Record last verified: 2025-10

Locations

US(14)