Pivotal Study for the Cardiac Performance System (CPS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Device: Cardiac Performance System (CPS)

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Recruiting
      • Huntsville Hospital Heart Center
      • Contact: Principal Investigator; Phone Number: 256-519-8472; Email: csullivan@theheartcenter.md
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Recruiting
      • Endeavor Health
      • Contact: Principal Investigator; Phone Number: 847-570-2250; Email: clinicaltrials@northshore.org
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Recruiting
      • Hackensack University Medical Center
      • Contact: Principal Investigator; Phone Number: 551-996-2255; Email: ora@hmhn.org
    • Neptune City, New Jersey, United States, 07753
      • Recruiting
      • Jersey Shore University Medical Center
      • Contact: Principal Investigator; Phone Number: 551-996-2255; Email: ora@hmhn.org
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
      • Contact: Principal Investigator; Phone Number: 212-305-5064; Email: ctoinformation@columbia.edu
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Medical Center
      • Contact: Principal Investigator; Phone Number: 614-685-4619; Email: cardiovascular.research@osumc.edu
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania - Penn Presbyterian Medical Center
      • Contact: Principal Investigator; Phone Number: 215-662-4484; Email: psom-ocr@pobox.upenn.edu
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Contact: Principal Investigator; Phone Number: 843-792-2300; Email: musc-ocr@musc.edu
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Recruiting
      • The Stern Cardiovascular Foundation, Inc. / Baptist Memorial Hospital
      • Contact: Principal Investigator; Phone Number: 901-271-1000; Email: sharon.goldstein@sterncardio.com
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine
      • Contact: Principal Investigator; Phone Number: 713-798-1297; Email: ClinicalResearch@bcm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients aged 18 years and older who are scheduled to undergo clinically indicated right heart catheterization as part of their standard medical care. Participants will represent a diverse range of individuals with conditions requiring invasive hemodynamic assessment.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CPS Measurement Group; Participants undergoing clinically indicated right heart catheterization will receive a single, non-invasive measurement using the Cardiac Performance System (CPS) before their scheduled procedure. The study aims to compare CPS results with standard invasive hemodynamic measurements.	Device: Cardiac Performance System (CPS); CPS is a non-invasive platform for hemodynamic assessment that uses acoustic sensors and electrocardiogram electrodes.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sensydia Corporation

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2025
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: February 24, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Right Heart Catheterization; CPS; Cardiac Performance System; Hemodynamic Parameters
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: CPS_PIVOTAL

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No