Recruiting

Cardiac Performance System

Sponsor:

Sensydia Corporation

Code:

NCT06870591

Conditions

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cardiac Performance System (CPS)

Study Details

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.

Conditions

Cardiovascular Diseases

Study ID

NCT06870591

Start date

Apr 22, 2025

Status verified date

Jun, 2025

Completion date

May 30, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Cardiac Performance System (CPS)

CPS is a non-invasive platform for hemodynamic assessment that uses acoustic sensors and electrocardiogram electrodes.

Primary outcome measure

  • Cardiac Performance System electronic data for Pulmonary Pressure [ Time Frame: Single measurement prior to right heart catheterization ]
  • Pulmonary artery catheter electronic data for Pulmonary Pressure [ Time Frame: During right heart catheterization procedure ]

Central Contacts and Locations

Locations

Huntsville Hospital Heart Center

Recruiting

Huntsville, Alabama, United States, 35801

Contacts

Principal Investigator

256-519-8472csullivan@theheartcenter.md

Endeavor Health

Recruiting

Evanston, Illinois, United States, 60201

Contacts

Principal Investigator

847-570-2250clinicaltrials@northshore.org

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Principal Investigator

551-996-2255ora@hmhn.org

Jersey Shore University Medical Center

Recruiting

Neptune City, New Jersey, United States, 07753

Contacts

Principal Investigator

551-996-2255ora@hmhn.org

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

Recruiting

New York, New York, United States, 10032

Contacts

Principal Investigator

212-305-5064ctoinformation@columbia.edu

The Ohio State University Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator

614-685-4619cardiovascular.research@osumc.edu

University of Pennsylvania - Penn Presbyterian Medical Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator

215-662-4484psom-ocr@pobox.upenn.edu

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Principal Investigator

843-792-2300musc-ocr@musc.edu

The Stern Cardiovascular Foundation, Inc. / Baptist Memorial Hospital

Recruiting

Germantown, Tennessee, United States, 38138

Contacts

Principal Investigator

901-271-1000sharon.goldstein@sterncardio.com

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator

713-798-1297ClinicalResearch@bcm.edu

More Information

Sponsor

Sensydia Corporation

Last update posted

Apr 24, 2026

Last verified

Jun, 2025

Keywords

  • Cardiac Performance System
  • CPS
  • Hemodynamic Parameters
  • Right Heart Catheterization

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Sensydia Corporation on 2026-04-24.