An Evaluation of the Safety and Performance of the Aortix System for Intra-Aortic Mechanical Circulatory Support in Patients With Cardiorenal Syndrome

  • STATUS
    Not Recruiting
  • End date
    Jun 11, 2023
  • participants needed
    60
  • sponsor
    Procyrion
Updated on 20 October 2022
renal function
edema
ejection fraction
heart failure
dyspnea
diuretics
orthopnea
chronic heart failure
congestion
diuretic therapy
decompensated heart failure
acute decompensated heart failure

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

Description

The study is a prospective, multi-center, non-randomized feasibility study to evaluate the safety and performance of the Aortix System in patients hospitalized with acute decompensated heart failure (ADHF) and worsening renal function refractory to medical management with persistent congestion. The Aortix system consists of the Aortix Delivery System, Introducer Set, the Aortix Pump, the Aortix Control System, and the Aortix Retrieval System.

Details
Condition Heart Failure; With Decompensation, Cardiorenal Syndrome, Cardio-Renal Syndrome, Heart Failure, Heart Failure,Congestive, Heart Failure, Systolic, Heart Failure, Diastolic
Treatment Aortix System
Clinical Study IdentifierNCT04145635
SponsorProcyrion
Last Modified on20 October 2022

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