Cardiovascular DiseasesNCT06870591
Pivotal Study for the Cardiac Performance System (CPS)
An observational study of Cardiovascular Diseases, run by Sensydia Corporation at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Cardiac Performance System (CPS)
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 10 sitesUnited States
- Study dates
- 22 Apr 2025to 30 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Adults aged 18 years or older
- Scheduled for clinically indicated right heart catheterization
- Ability to provide informed consent
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Principal Investigator, 843-792-2300, musc-ocr@musc.edu
- Recruiting
The Ohio State University Medical Center
Columbus, Ohio, 43210
Principal Investigator, 614-685-4619, cardiovascular.research@osumc.edu
- Recruiting
Endeavor Health
Evanston, Illinois, 60201
Principal Investigator, 847-570-2250, clinicaltrials@northshore.org
- Recruiting
The Stern Cardiovascular Foundation, Inc. / Baptist Memorial Hospital
Germantown, Tennessee, 38138
Principal Investigator, 901-271-1000, sharon.goldstein@sterncardio.com
- Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Principal Investigator, 551-996-2255, ora@hmhn.org
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Principal Investigator, 713-798-1297, ClinicalResearch@bcm.edu
- Recruiting
Huntsville Hospital Heart Center
Huntsville, Alabama, 35801
Principal Investigator, 256-519-8472, csullivan@theheartcenter.md
- Recruiting
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Principal Investigator, 551-996-2255, ora@hmhn.org
- Recruiting
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
New York, New York, 10032
Principal Investigator, 212-305-5064, ctoinformation@columbia.edu
- Recruiting
University of Pennsylvania - Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Principal Investigator, 215-662-4484, psom-ocr@pobox.upenn.edu
About this study
Official title: 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.
Read the 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
- Being tested
- Cardiac Performance System (CPS)
- Keywords
- Cardiac Performance System, CPS, Hemodynamic Parameters, Right Heart Catheterization
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Performance System (CPS)Device
CPS is a non-invasive platform for hemodynamic assessment that uses acoustic sensors and electrocardiogram electrodes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cardiac Performance System (CPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Performance System electronic data for Pulmonary Pressure
Cardiac function metric measurement including Pulmonary Pressure measured in mmHg
Measured: 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
Measured: During right heart catheterization procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start22 Apr 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sensydia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870591
- Sponsor's protocol ID
- CPS_PIVOTAL
- Status last verified
- Jun 2025
- First submitted
- 24 Feb 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Method-Comparison Study for the Cardiac Performance System (CPS) to Measure Hemodynamic Parameters
- ClinicalTrials.gov ID
- NCT06870591
- Acronym / sponsor ID
- CPS_PIVOTAL
- Conditions
- Cardiovascular Diseases
- Keywords
- Cardiac Performance System, CPS, Hemodynamic Parameters, Right Heart Catheterization
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Sensydia CorporationIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPS Measurement Group | – | Device: Cardiac Performance System (CPS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Adults aged 18 years or older
- Scheduled for clinically indicated right heart catheterization
- Ability to provide informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Performance System (CPS)CPS is a non-invasive platform for hemodynamic assessment that uses acoustic sensors and electrocardiogram electrodes. | Device | CPS Measurement Group |
Primary outcome
Cardiac Performance System electronic data for Pulmonary Pressure
Time frame: 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
Time frame: During right heart catheterization procedure
Cardiac function metric measurement including Pulmonary Pressure measured in mmHg
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Sensydia Corporation at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Performance System electronic data for Pulmonary Pressure (time frame: Single measurement prior to right heart catheterization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.