NCT04145635

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Procyrion · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-02-05
• Primary completion: 2022-10-07
• Completion: 2023-03-09
• First posted: 2019-10-30
• Last updated: 2024-04-17
• Results posted: 2024-04-17

Locations

19 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated device study