MedPath

Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure

Not Applicable
Recruiting
Conditions
Heart Failure
Heart Failure; With Decompensation
Heart Failure, Congestive
Cardiorenal Syndrome
Cardio-Renal Syndrome
ADHF
Heart Failure, Diastolic
Heart Failure, Systolic
Registration Number
NCT05677100
Lead Sponsor
Procyrion
Brief 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.

Detailed Description

The study is a prospective, multi-center, randomized, nonblinded study to evaluate the safety and effectiveness of the Aortix System versus standard of care medical therapy in patients hospitalized with acute decompensated heart failure (ADHF) and persistent congestion despite usual medical management.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. Randomization will be stratified by ejection fraction..

An additional registry arm will enroll patients who are considered candidates for advanced therapies in the near-term, but need improvement in their renal function to be able to receive additional medical therapies. All eligible enrolled registry subjects will receive Aortix system support.

Planned study population is male or female patients 21 years of age or greater, with acute decompensated heart failure and diuretic resistance who remain congested despite standard of care medical therapy.

This study will enroll up to 295 subjects with heart failure at 45 clinical sites in the United States and up to 5 OUS sites. The randomized study includes up to 215 subjects and the Advanced HF registry includes up to 80 subjects.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
295
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Primary Safety Endpoint: Incidence of Aortix Device / Procedural-Related Major Adverse Events (MAE) through 30 days of Follow-up.Baseline to 30 day Follow-Up

Incidence of Major Adverse Events

Primary Effectiveness Endpoint: Combined composite of clinically significant reduction in net fluid loss over 7 days and freedom from mortality or heart failure re-hospitalization/therapy escalation from the baseline visit to the 30-day follow-up visit.Baseline to 30 day Follow-Up

Composite of net fluid loss, mortality and HF hospitalization/escalation of therapy

Secondary Outcome Measures
NameTimeMethod
Incidence and percentages of major adverse events (MAE) PooledBaseline to 30 day Follow-Up

Incidence and percentages of major adverse events (MAE) pooled analysis of Aortix randomized cohort and registry cohort

eGFRBaseline to 30 day Follow-Up

Evaluation of changes in eGFR

All-cause MortalityBaseline to 30 day Follow-Up

Rate of mortality

Patient Reported Dyspnea AssessmentBaseline to 30 day Follow-Up

Change in patient reported dyspnea scale

Standing body weightBaseline to 30 day Follow-Up

Change in standing body weight

HF Re-Hospitalization or escalation of HF therapyBaseline to 30 day Follow-Up

Evaluation of HF re-hospitalization and therapy escalation

Net Fluid LossBaseline to Day 7

Change in Net Fluid Loss from Baseline to Day 7/Discharge

NT-proBNPBaseline to 30 day Follow-Up

Evaluation of NT-proBNP

Trial Locations

Locations (46)

Birmingham VA Health Care System

🇺🇸

Birmingham, Alabama, United States

Banner--University Medical Center Phoenix

🇺🇸

Phoenix, Arizona, United States

Mayo Clinic - Arizona

🇺🇸

Phoenix, Arizona, United States

HonorHealth Medical Center

🇺🇸

Scottsdale, Arizona, United States

John Muir Health

🇺🇸

Concord, California, United States

Zuckerberg San Francisco General

🇺🇸

San Francisco, California, United States

San Francisco Veterans Administration

🇺🇸

San Francisco, California, United States

University of California San Francisco

🇺🇸

San Francisco, California, United States

Ascension Sacred Heart

🇺🇸

Pensacola, Florida, United States

Tallahassee Research Institute

🇺🇸

Tallahassee, Florida, United States

Scroll for more (36 remaining)
Birmingham VA Health Care System
🇺🇸Birmingham, Alabama, United States
Jill Owens
Contact
Massoud Leesar, MD
Principal Investigator

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.