Heart DiseasesNCT05104307
Echocardiogram and Cardiac Performance System (CPS) Ejection Fraction Validation Study
An observational study of Heart Diseases, run by Stephen Esper at 1 site in United States.
Trial summary
Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Cardiac Performance System (CPS) Device
- Type of treatment
- Medical device
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2021to 2 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients scheduled for a standard echocardiogram
Who may be able to join
- Patients over 18 scheduled for a standard echocardiogram
Who cannot join
- Patients with heart transplant history
- Patients with a Implanted Left Ventricular Assist Device (LVAD)
- Patients who have surgical scars, wounds, or bandages at the site of sensor placement
- Inadequate TTE imaging windows in left lateral position
- Otherwise deemed by the investigator as medically unfit to participate
- Chest deformities including, for example, pectus excavatum
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Montefiore Hospital
Pittsburgh, Pennsylvania, 15212
About this study
Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)
Read the detailed description
This validation study will help to establish feasibility of using the CPS monitor to screen patients for ejection fraction (EF), CO, PASP and wedge pressure compared to a standard echocardiogram. No clinical decisions will be made as a result of the CPS device EF value and this measurement will be taken for comparison purposes only.
- Conditions
- Heart Diseases
- Being tested
- Cardiac Performance System (CPS) Device
- Keywords
- cardiovascular
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Performance System (CPS) DeviceDevice
CPS is a passive measurement system that acquires signals from multiple sensor sources that monitor cardiac heart sounds. The passive sensor systems measure sound only and do not produce energy. The CPS system also includes a Patient Monitor device that acquires data from the sensors as well as from three standard ECG electrodes. The CPS system does not acquire or store any protected health information or any subject characteristics. The CPS system has received FDA clearance K173156. Note that the CPS system was previously named Integrated CardioRespiratory (ICR) system. The CPS is FDA cleared for the ejection fraction (EF) assessment which will be its intended use for this study.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Performance System (NSR) | Subjects will wear Cardiac Performance System (CPS) non-invasive device during their standard echocardiogram Receives: Device: Cardiac Performance System (CPS) Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Performance System electronic data for Ejection Fraction
Cardiac function measurement including left ventricle ejection fraction to report in percentage
Measured: 60 minutes during Echocardiography procedure
Cardiac Performance System electronic data for Cardiac Output
Cardiac function metric measurement including Cardiac Output to report in L/m
Measured: 60 minutes during Echocardiography procedure
Cardiac Performance System electronic data for Pulmonary Artery Pressure
Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.
Measured: 60 minutes during Echocardiography procedure
Cardiac Performance System electronic data for Pulmonary Artery Wedge Pressure
Cardiac function metric measurement including Pulmonary Artery Wedge Pressure to report in mmHg
Measured: 60 minutes during Echocardiography procedure
Echocardiography electronic data for Ejection Fraction
Cardiac function measurement including left ventricle ejection fraction to report in percentage
Measured: 60 minutes during Echocardiography procedure
Echocardiography electronic data for Cardiac Output
Cardiac function metric measurement including Cardiac Output to report in L/m
Measured: 60 minutes during Echocardiography procedure
Echocardiography electronic data for Pulmonary Artery Pressure
Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.
Measured: 60 minutes during Echocardiography procedure
Echocardiography electronic data for Pulmonary Artery Wedge Pressure
Cardiac function metric measurement including Pulmonary Artery Wedge Pressure to report in mmHg
Measured: 60 minutes during Echocardiography procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start9 Nov 2021
- Primary completion2 Jan 2024
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephen Esper
- Sponsor type
- University, hospital or other
- Collaborators
- Sensydia Corporation
- Responsible party
- Sponsor-investigator, Stephen Esper, University of Pittsburgh
- Investigators
- Stephen L Esper, MD, MBA, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104307
- Sponsor's protocol ID
- STUDY21050167
- Status last verified
- May 2024
- First submitted
- 14 Oct 2021
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiogram and Cardiac Performance System (CPS) Ejection Fraction Validation Study
- ClinicalTrials.gov ID
- NCT05104307
- Acronym / sponsor ID
- STUDY21050167
- Conditions
- Heart Diseases
- Keywords
- cardiovascular
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Stephen EsperUniversity, hospital or other
- Collaborators
- Sensydia Corporation
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 2 Jan 2024 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 2 Nov 2021 (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.
Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)
Detailed description
This validation study will help to establish feasibility of using the CPS monitor to screen patients for ejection fraction (EF), CO, PASP and wedge pressure compared to a standard echocardiogram. No clinical decisions will be made as a result of the CPS device EF value and this measurement will be taken for comparison purposes only.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Performance System (NSR) | – | Device: Cardiac Performance System (CPS) DeviceSubjects will wear Cardiac Performance System (CPS) non-invasive device during their standard echocardiogram |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for a standard echocardiogram
Key inclusion criteria (1 listed)
- Patients over 18 scheduled for a standard echocardiogram
Key exclusion criteria (6 listed)
- Patients with heart transplant history
- Patients with a Implanted Left Ventricular Assist Device (LVAD)
- Patients who have surgical scars, wounds, or bandages at the site of sensor placement
- Inadequate TTE imaging windows in left lateral position
- Otherwise deemed by the investigator as medically unfit to participate
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) DeviceCPS is a passive measurement system that acquires signals from multiple sensor sources that monitor cardiac heart sounds. The passive sensor systems measure sound only and do not produce energy. The CPS system also includes a Patient Monitor device that acquires data from the sensors as well as from three standard ECG electrodes. The CPS system does not acquire or store any protected health information or any subject characteristics. The CPS system has received FDA clearance K173156. Note that the CPS system was previously named Integrated CardioRespiratory (ICR) system. The CPS is FDA cleared for the ejection fraction (EF) assessment which will be its intended use for this study. | Device | Cardiac Performance System (NSR) |
Primary outcome
Cardiac Performance System electronic data for Ejection Fraction
Time frame: 60 minutes during Echocardiography procedure
Cardiac function measurement including left ventricle ejection fraction to report in percentage
Cardiac Performance System electronic data for Cardiac Output
Time frame: 60 minutes during Echocardiography procedure
Cardiac function metric measurement including Cardiac Output to report in L/m
Cardiac Performance System electronic data for Pulmonary Artery Pressure
Time frame: 60 minutes during Echocardiography procedure
Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.
Cardiac Performance System electronic data for Pulmonary Artery Wedge Pressure
Time frame: 60 minutes during Echocardiography procedure
Cardiac function metric measurement including Pulmonary Artery Wedge Pressure to report in mmHg
Echocardiography electronic data for Ejection Fraction
Time frame: 60 minutes during Echocardiography procedure
Cardiac function measurement including left ventricle ejection fraction to report in percentage
Echocardiography electronic data for Cardiac Output
Time frame: 60 minutes during Echocardiography procedure
Cardiac function metric measurement including Cardiac Output to report in L/m
Echocardiography electronic data for Pulmonary Artery Pressure
Time frame: 60 minutes during Echocardiography procedure
Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.
Echocardiography electronic data for Pulmonary Artery Wedge Pressure
Time frame: 60 minutes during Echocardiography procedure
Cardiac function metric measurement including Pulmonary Artery Wedge Pressure to report in mmHg
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Stephen L Esper, MD, MBA principal investigator
University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases, run by Stephen Esper at 1 site 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Performance System electronic data for Ejection Fraction (time frame: 60 minutes during Echocardiography procedure). The study lists 8 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 6 May 2024.