Cardiac DiseaseNCT06149143
Cardiac Performance System Data Collection Study - Minnesota
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 22 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
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2023to 30 Jun 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled for cardiac catheterization procedure
Who may be able to join
- Ability to provide written informed consent
- 22 years of age or older
- Referred for cardiac catheterization for reasons including heart failure, evaluation before transplant, pulmonary hypertension, shortness of breath, valvular disease, etc.
Who cannot join
- Previous Heart Transplant
- Presence of Left Ventricular Assist Device
- Presence of a Holter monitor or any other electrical leads on the chest at the time of sensor placement
- Surgical scars/wounds/bandages/ports at the site of sensor placement
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Tamas Alexy
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
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
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.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Function Monitoring | Subjects scheduled for cardiac catheterization will undergo measurement with the Cardiac Performance System non-invasive device for a brief period before the catheterization procedure. 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: 10 minutes before cardiac catheterization procedure
Cardiac Performance System electronic data for Pulmonary Artery Pressure
Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.
Measured: 10 minutes before cardiac catheterization procedure
Cardiac Performance System electronic data for Pulmonary Capillary Wedge Pressure
Cardiac function metric measurement including Pulmonary Capillary Wedge Pressure to report in mmHg.
Measured: 10 minutes before cardiac catheterization 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 cardiac catheterization 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 cardiac catheterization procedure
Pulmonary Artery Catheter electronic data for Pulmonary Capillary Wedge Pressure
Cardiac function metric measurement including Pulmonary Capillary Wedge Pressure to report in mmHg.
Measured: 60 minutes during cardiac catheterization 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 posted28 Nov 2023
- Study start3 Oct 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
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
- 50 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
- NCT06149143
- Sponsor's protocol ID
- CPS_MINNESOTA
- Status last verified
- Apr 2024
- First submitted
- 20 Nov 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Performance System Data Collection Study - Minnesota
- ClinicalTrials.gov ID
- NCT06149143
- Acronym / sponsor ID
- CPS_MINNESOTA
- Conditions
- Cardiac Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sensydia CorporationIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 28 Nov 2023 (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 scheduled for cardiac catheterization will undergo measurement with the Cardiac Performance System non-invasive device for a brief period before the catheterization procedure. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for cardiac catheterization procedure
Key inclusion criteria (3 listed)
- Ability to provide written informed consent
- 22 years of age or older
- Referred for cardiac catheterization for reasons including heart failure, evaluation before transplant, pulmonary hypertension, shortness of breath, valvular disease, etc.
Key exclusion criteria (4 listed)
- Previous Heart Transplant
- Presence of Left Ventricular Assist Device
- Presence of a Holter monitor or any other electrical leads on the chest at the time of sensor placement
- Surgical scars/wounds/bandages/ports 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)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. | Device | Cardiac Function Monitoring |
Primary outcome
Cardiac Performance System electronic data for Cardiac Output
Time frame: 10 minutes before cardiac catheterization procedure
Cardiac function metric measurement including Cardiac Output to report in L/m.
Cardiac Performance System electronic data for Pulmonary Artery Pressure
Time frame: 10 minutes before cardiac catheterization procedure
Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.
Cardiac Performance System electronic data for Pulmonary Capillary Wedge Pressure
Time frame: 10 minutes before cardiac catheterization procedure
Cardiac function metric measurement including Pulmonary Capillary Wedge Pressure to report in mmHg.
Pulmonary Artery Catheter electronic data for Cardiac Output
Time frame: 60 minutes during cardiac catheterization 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 cardiac catheterization procedure
Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.
Pulmonary Artery Catheter electronic data for Pulmonary Capillary Wedge Pressure
Time frame: 60 minutes during cardiac catheterization procedure
Cardiac function metric measurement including Pulmonary Capillary 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 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.
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 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: status not confirmed, as of the sponsor's last update on 17 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sensydia (6618774670, info[@]sensydia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Performance System electronic data for Cardiac Output (time frame: 10 minutes before cardiac catheterization 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 17 Apr 2024.