Physiologic Signals and Signatures With the Accuryn Monitoring System - The Accuryn Registry
Recruiting · NCT04669548 · Observational (researchers observe without assigning treatment) · Lead sponsor: Potrero Medical
View the official record on ClinicalTrials.gov →Interventions studied
Accuryn Monitoring System
What this trial is about
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 can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Signed or Verbal Informed Consent as required by IRB (if applicable).
- Adult (age ≥ 18).
- Monitored on the Accuryn® Monitoring System during their procedure and ICU stay (for retrospective enrollment).
- Patient is undergoing cardiac surgical intervention(s).
Exclusion criteria
- 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.
- 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.
Where it is running
9 locations listed across 6 US states.
- 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