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

Sponsored by Potrero Medical

About this trial

Last updated 3 years ago

Study ID

CRD-06-101904

Status

Recruiting

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 5 years ago

What is this trial 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.

What are the participation requirements?

Yes

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).

No

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.

Locations

Location

Status

Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Active, not recruiting
Active, not recruiting
Terminated