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Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure

NCT05677100 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2026-05-22

No results posted yet for this study

Summary

Aortix is a circulatory support device for chronic heart failure patients on medical management who have been hospitalized for acute decompensated heart failure (ADHF) and have persistent congestion despite usual medical therapy.

Eligible ADHF patients with diuretic resistance (irrespective of ejection fraction) will be enrolled and randomized 1:1 to either the Aortix system or standard of care medical management.

Conditions

  • Heart Failure
  • Cardiorenal Syndrome
  • Cardio-Renal Syndrome
  • ADHF
  • Heart Failure, Systolic
  • Heart Failure, Diastolic
  • Heart Failure; With Decompensation
  • Heart Failure, Congestive

Interventions

DEVICE

Aortix System

Aortix is a circulatory support device for chronic heart failure patients on medical management who have been hospitalized for acute decompensated heart failure (ADHF) and are resistant to diuretic therapy.

Sponsors & Collaborators

  • Procyrion

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-23
Primary Completion
2027-01-31
Completion
2027-08-31
FDA Device
Yes

Countries

  • United States
  • Hungary

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05677100 on ClinicalTrials.gov