Cardiac DiseaseNCT04131725
Cardiac Function Non-Invasive Monitoring System Evaluation Trial
An observational study of Cardiac Disease, run by Sensydia Corporation 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 olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- Cardiac Performance System (NSR)
- Type of treatment
- Medical device
- How many people
- 275 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2020to 30 Apr 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled for Pulmonary Artery Catheter procedure
Who may be able to join
- Adults of age 18 or older
Who cannot join
- Subjects with wounds or surgical incisions at the site of sensor placement
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15261
About this study
Official title: Cardiac Function Monitoring System Evaluation
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
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)
- Conditions
- Cardiac Disease
- Being tested
- Cardiac Performance System (NSR)
- 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 (NSR)Device
Device: Cardiac Performance System Participants will be asked to wear the Cardiac Performance System, a non-invasive sensor device on their upper abdomen. The Cardiac Performance System monitoring device will continuously monitor cardiac function. The device will be worn at the time when Pulmonary Artery Catheter procedures are conducted.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Function Monitoring | Subjects will wear Cardiac Performance System (CPS) non-invasive device for brief periods during procedures including assessment by Pulmonary Artery Catheter (PAC) methods. Receives: Device: Cardiac Performance System (NSR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Performance System electronic data for Cardiac Output
Cardiac function metric measurement including Cardiac Output to report in L/m.
Measured: 60 minutes during Pulmonary Artery Catheter 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 Pulmonary Artery Catheter 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 Pulmonary Artery Catheter procedure
Pulmonary Artery Catheter electronic data for Cardiac Output
Cardiac function metric measurement including Cardiac Output to report in L/m.
Measured: 60 minutes during Pulmonary Artery Catheter procedure
Pulmonary Artery Catheter electronic data for Pulmonary Artery Pressure
Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.
Measured: 60 minutes during Pulmonary Artery Catheter procedure
Pulmonary Artery Catheter electronic data for Pulmonary Artery Wedge Pressure
Cardiac function metric measurement including Pulmonary Artery Wedge Pressure to report in mmHg.
Measured: 60 minutes during Pulmonary Artery Catheter procedure
Echocardiography electronic data for Ejection Fraction
Cardiac function measurement including left ventricle ejection fraction to report in percentage.
Measured: 15 minutes at a time prior to or after Pulmonary Artery Catheter procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start9 Nov 2020
- Primary completion1 Feb 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies 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
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensydia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pittsburgh Medical Center
- Responsible party
- Sponsor
- Investigators
- William Kaiser, PhD, Principal investigator, Sensydia Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131725
- Sponsor's protocol ID
- CPS_002_2019
- Status last verified
- Nov 2023
- First submitted
- 14 Oct 2019
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Function Monitoring System Evaluation
- ClinicalTrials.gov ID
- NCT04131725
- Acronym / sponsor ID
- CPS_002_2019
- Conditions
- Cardiac Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Sensydia CorporationIndustry (pharma, biotech, devices)
- Collaborators
- University of Pittsburgh Medical Center
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 18 Oct 2019 (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
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)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Function Monitoring | – | Device: Cardiac Performance System (NSR)Subjects will wear Cardiac Performance System (CPS) non-invasive device for brief periods during procedures including assessment by Pulmonary Artery Catheter (PAC) methods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for Pulmonary Artery Catheter procedure
Key inclusion criteria (1 listed)
- Adults of age 18 or older
Key exclusion criteria (1 listed)
- Subjects with wounds or surgical incisions at the site of sensor placement
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 (NSR)Device: Cardiac Performance System Participants will be asked to wear the Cardiac Performance System, a non-invasive sensor device on their upper abdomen. The Cardiac Performance System monitoring device will continuously monitor cardiac function. The device will be worn at the time when Pulmonary Artery Catheter procedures are conducted. | Device | Cardiac Function Monitoring |
Primary outcome
Cardiac Performance System electronic data for Cardiac Output
Time frame: 60 minutes during Pulmonary Artery Catheter 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 Pulmonary Artery Catheter 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 Pulmonary Artery Catheter procedure
Cardiac function metric measurement including Pulmonary Artery Wedge Pressure to report in mmHg.
Pulmonary Artery Catheter electronic data for Cardiac Output
Time frame: 60 minutes during Pulmonary Artery Catheter procedure
Cardiac function metric measurement including Cardiac Output to report in L/m.
Pulmonary Artery Catheter electronic data for Pulmonary Artery Pressure
Time frame: 60 minutes during Pulmonary Artery Catheter procedure
Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.
Pulmonary Artery Catheter electronic data for Pulmonary Artery Wedge Pressure
Time frame: 60 minutes during Pulmonary Artery Catheter procedure
Cardiac function metric measurement including Pulmonary Artery Wedge Pressure to report in mmHg.
Echocardiography electronic data for Ejection Fraction
Time frame: 15 minutes at a time prior to or after Pulmonary Artery Catheter procedure
Cardiac function measurement including left ventricle ejection fraction to report in percentage.
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 22 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Cardiac Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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.
William Kaiser, PhD principal investigator
Sensydia Corporation
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 Cardiac Disease, run by Sensydia Corporation 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 1 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 22 Nov 2023. 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 Cardiac Output (time frame: 60 minutes during Pulmonary Artery Catheter procedure). The study lists 7 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 22 Nov 2023.