NCT05866666

Cardiac Performance System Data Collection Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 115 (estimated)
• Sponsor: Sensydia Corporation · Industry
• Sex: All
• Age: 22 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)	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.

Timeline

• Start date: 2023-05-30
• Primary completion: 2024-05-31
• Completion: 2024-05-31
• First posted: 2023-05-19
• Last updated: 2023-11-21

Locations

1 site across 1 country: United States