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RECRUITINGOBSERVATIONAL

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Signed or Verbal willing to sign a consent form as required by IRB (if applicable). 2. Adult (age ≥ 18). 3. Monitored on the Accuryn® Monitoring System during their procedure and ICU stay (for retrospective enrollment). 4. Patient is undergoing cardiac surgical intervention(s). Who Should NOT Join This Trial: 1. Known history of advanced chronic kidney disease defined by an estimated glomerular filtration rate (eGFR) \<20 mL/min/1.73m2 within 30 days prior to procedure. 2. The patient is unsuitable for the study, in the opinion of the investigator. This may include vulnerable patient populations such as pregnant women, prisoners ,or those detained in a penal institution. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Signed or Verbal Informed Consent as required by IRB (if applicable). 2. Adult (age ≥ 18). 3. Monitored on the Accuryn® Monitoring System during their procedure and ICU stay (for retrospective enrollment). 4. Patient is undergoing cardiac surgical intervention(s). Exclusion Criteria: 1. Known history of advanced chronic kidney disease defined by an estimated glomerular filtration rate (eGFR) \<20 mL/min/1.73m2 within 30 days prior to procedure. 2. The patient is unsuitable for the study, in the opinion of the investigator. This may include vulnerable patient populations such as pregnant women, prisoners ,or those detained in a penal institution.

Treatments Being Tested

DEVICE

Accuryn 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.

Locations (9)

Cedars-Sinai Medical Center
Los Angeles, California, United States
San Francisco VA Medical Center
San Francisco, California, United States
George Washington University Hospital
Washington D.C., District of Columbia, United States
Cleveland Clinic Florida
Weston, Florida, United States
Jewish Hospital / University of Louisville
Louisville, Kentucky, United States
Mission Health Hospital
Asheville, North Carolina, United States
Duke University Hospital
Durham, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States