RecruitingNCT04669548

Physiologic Signals and Signatures With the Accuryn Monitoring System - The Accuryn Registry

Physiologic Signals and Signatures With the Accuryn Monitoring System - A Retrospective and Prospective Analysis (The Accuryn Registry)

Sponsor

Potrero Medical

Enrollment

2,500 participants

Start Date

Dec 21, 2020

Study Type

OBSERVATIONAL

Conditions

Acute Kidney Injury Intraabdominal Hypertension Abdominal Compartment Syndrome Cardiovascular Surgery

Summary

The Accuryn Registry Study is an open-ended, global, multi-center, retrospective and prospective, single-arm data collection study with an FDA cleared device. The target population are cardiovascular surgery patients. Physiologic data measurements will be collected from enrolled subjects using electronic medical records and data streams via the Accuryn Monitoring System.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This registry study is collecting data from patients who are being monitored with a device called the Accuryn Monitoring System during and after heart surgery in the ICU. The goal is to build a database of physiological signals to better understand and improve care for cardiac surgery patients. **You may be eligible if you:** - Are 18 years of age or older - Are undergoing a cardiac (heart) surgical procedure - Are being monitored with the Accuryn Monitoring System during your procedure and ICU stay **You may NOT be eligible if you:** - Have advanced chronic kidney disease (very low kidney filtration rate within the past 30 days) - Are pregnant - Are incarcerated - Are otherwise considered unsuitable for the study by the research team Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAccuryn Monitoring System

The Accuryn Monitoring System is a novel Foley catheter and monitoring device capable of detecting physiologic changes in vital signs via sensors within the catheter system. These data are captured non-invasively, continuously, and at a high frequency.