NCT04131725

Cardiac Function Non-Invasive Monitoring System Evaluation Trial

Cardiac Function Monitoring System Evaluation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 275 (actual)
• Sponsor: Sensydia Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)

Detailed description

Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)

Conditions

• Cardiac Disease

Interventions

Type	Name	Description
DEVICE	Cardiac Performance System (NSR)	Device: Cardiac Performance System Participants will be asked to wear the Cardiac Performance System, a non-invasive sensor device on their upper abdomen. The Cardiac Performance System monitoring device will continuously monitor cardiac function. The device will be worn at the time when Pulmonary Artery Catheter procedures are conducted.

Timeline

• Start date: 2020-11-09
• Primary completion: 2023-02-01
• Completion: 2023-04-30
• First posted: 2019-10-18
• Last updated: 2023-11-22

Locations

1 site across 1 country: United States