MedTrace Logo

The Aortix CRS Pilot Study

NCT04145635 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-04-17

Study results available
· View outcomes & findings →

Summary

The Aortix CRS Pilot Study: An Evaluation of the Safety and Performance of the Aortix System for Intra-Aortic Mechanical Circulatory Support in Patients with Cardiorenal Syndrome

Conditions

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

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) with worsening renal function.

Sponsors & Collaborators

  • Procyrion Australia Pty Ltd

    collaborator INDUSTRY

  • Procyrion

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-05
Primary Completion
2022-10-07
Completion
2023-03-09
FDA Device
Yes

Countries

  • United States
  • Australia

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 NCT04145635 on ClinicalTrials.gov