Recruiting

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

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.

ClinicalTrials.gov IDNCT04669548

PhaseNot Applicable

Enrollment2500

SponsorPotrero Medical

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Intraabdominal Hypertension, Abdominal Compartment Syndrome, Acute Kidney Injury, Cardiovascular Surgery

About this study

Interventions

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.

Primary outcomes

Urine Output (UO) (30 days)
Intra-Abdominal Pressure (IAP) (30 days)
Temperature (T) (30 days)
Intraabdominal Hypertension (IAH) (30 days)
Abdominal Compartment Syndrome (ACS) (30 days)
Acute Kidney Injury (AKI) (30 days)

Eligibility information

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.

Study locations

Cedars-Sinai Medical Center, Los Angeles, California 90048 United States
San Francisco VA Medical Center, San Francisco, California 94121 United States
George Washington University Hospital, Washington D.C., District of Columbia 20037 United States
Cleveland Clinic Florida, Weston, Florida 33331 United States
Jewish Hospital / University of Louisville, Louisville, Kentucky 40202 United States
Mission Health Hospital, Asheville, North Carolina 28803 United States
Duke University Hospital, Durham, North Carolina 27710 United States
Wake Forest Baptist Medical Center, Winston-Salem, North Carolina 27157 United States
Cleveland Clinic, Cleveland, Ohio 44195 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.