NCT06870591

Pivotal Study for the Cardiac Performance System (CPS)

Pivotal Method-Comparison Study for the Cardiac Performance System (CPS) to Measure Hemodynamic Parameters

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Sensydia Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

This multi-center, observational study evaluates the accuracy of the Cardiac Performance System (CPS), a non-invasive device, for measuring hemodynamic parameters in adult patients undergoing clinically indicated right heart catheterization. The study compares CPS measurements to invasive measurements to assess agreement and potential clinical utility.

Detailed description

The study will enroll adults undergoing right heart catheterization as part of their clinical care. A single CPS measurement will be performed before the scheduled procedure. Data from both CPS and catheterization measurements will be analyzed to assess agreement. No investigational treatment or additional follow-up visits are required.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
DEVICE	Cardiac Performance System (CPS)	CPS is a non-invasive platform for hemodynamic assessment that uses acoustic sensors and electrocardiogram electrodes.

Timeline

• Start date: 2025-04-22
• Primary completion: 2026-01-31
• Completion: 2026-05-30
• First posted: 2025-03-11
• Last updated: 2025-12-03

Locations

10 sites across 1 country: United States