Pivotal Study for the Cardiac Performance System (CPS)
Pivotal Method-Comparison Study for the Cardiac Performance System (CPS) to Measure Hemodynamic Parameters
1 other identifier
observational
1,000
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2025
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2025
CompletedFirst Posted
Study publicly available on registry
March 11, 2025
CompletedStudy Start
First participant enrolled
April 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2026
ExpectedApril 24, 2026
June 1, 2025
1 year
February 24, 2025
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
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.
Interventions
CPS is a non-invasive platform for hemodynamic assessment that uses acoustic sensors and electrocardiogram electrodes.
Eligibility Criteria
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.
You may qualify if:
- Adults aged 18 years or older
- Scheduled for clinically indicated right heart catheterization
- Ability to provide informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Huntsville Hospital Heart Center
Huntsville, Alabama, 35801, United States
Endeavor Health
Evanston, Illinois, 60201, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
New York, New York, 10032, United States
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
University of Pennsylvania - Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
The Stern Cardiovascular Foundation, Inc. / Baptist Memorial Hospital
Germantown, Tennessee, 38138, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2025
First Posted
March 11, 2025
Study Start
April 22, 2025
Primary Completion
April 30, 2026
Study Completion (Estimated)
May 30, 2026
Last Updated
April 24, 2026
Record last verified: 2025-06