Pivotal Study for the Cardiac Performance System (CPS)

Recruiting

• Conditions: Cardiovascular Diseases

• Registration Number: NCT06870591
• Lead Sponsor: Sensydia Corporation

Brief 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.

Study Timeline

• Study First Submitted: 2025-02-24
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-05
• Study First Posted: 2025-03-11
• Study Start: 2025-04-22
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-11
• Primary Completion: 2025-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Adults aged 18 years or older
• Scheduled for clinically indicated right heart catheterization
• Ability to provide informed consent

Exclusion Criteria

• Heart transplant recipients
• Patients with a left ventricular assist device (LVAD)
• Presence of external devices (e.g., Holter monitors) or surgical scars/wounds that interfere with CPS measurements
• Measurement concerns related to data reliability or quality

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiac Performance System electronic data for Pulmonary Pressure	Single measurement prior to right heart catheterization	Cardiac function metric measurement including Pulmonary Pressure measured in mmHg
Pulmonary artery catheter electronic data for Pulmonary Pressure	During right heart catheterization procedure	Cardiac function metric measurement including Pulmonary Pressure measured in mmHg

Trial Locations

Locations (1)

Huntsville Hospital Heart Center; 🇺🇸 Huntsville, Alabama, United States