Cardiac FailureNCT04255108
Validation of a Sensor for Non-invasive Measurement of Stroke Volume and Cardiac Output
An observational study of Cardiac Failure, run by Baxter Healthcare Corporation at 1 site in United States.
Trial summary
toSense, Inc. has developed a novel, non-invasive, body-worn sensor -CoVa Patch-that offers an alternative to invasive continuous cardiac output monitoring. To validate this new sensor's measurements of stroke volume and cardiac output, toSense, Inc. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Failure
- What is being tested?
- Cova Patch
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2020to 9 Apr 2020
- 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: Men and woman over the age of 18 years old.
Who may be able to join
- Male or female ≥ 18 years of age at Visit X.
- Subject is a patient in the Cardiac ICU and meets the following criteria: pulmonary artery catheterization scheduled or completed.
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
- Subject is not pregnant at the time of consent
Who cannot join
- Pregnant in the study.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Subject is unable or unwilling to wear electrode patches as required for a period between 6 to 48 hours.
Trial locations and contacts
1 site in 1 country.
About this study
toSense, Inc. has developed a novel, non-invasive, body-worn sensor -CoVa Patch-that offers an alternative to invasive continuous cardiac output monitoring. To validate this new sensor's measurements of stroke volume and cardiac output, toSense, Inc. will conduct a study that compares its measurement performance to that from a pulmonary artery catheter using the thermodilution method.
Read the detailed description
This in an introductory clinical study with cardiac ICU patients featuring CoVa Patch. This is a single site, non-blinded, non-randomized study. It will employ a retrospective analysis comparing the accuracy of SV and CO. The 'test sensor', CoVa Patch, which will measure SV and CO quasi-continuously and non-invasively, approximately every 5-30 minutes for a period of time lasting approximately 12-48 hours. These measurements will be compared to those from a 'reference device', which is the pulmonary arterial catheter. It uses an invasive technique called thermodilution that will be made approximately every 4 hours. Measurements between the test and reference devices will be compared in a retrospective analysis once the study has completed.
- Conditions
- Cardiac Failure
- Being tested
- Cova Patch
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cova PatchDevice
CoVa Patch will measure quasi-continuously, approximately every 5 minutes for a period between 6 to 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Men/Women who meet the inclusion/exclusion criteria | Not described Receives: Device: Cova Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Stroke Volume
The primary objective of this study is to validate stroke volume (the amount of blood pumped by the left ventrical of the heart in one contraction) measurements made using CoVa Patch to those made using a pulmonary artery catheter and the thermodilution method.
Thermodilution requires a pulmonary artery catheter and are calculated by a monitoring system based on temperature changes in the heart when a cooler solution is injected into the right atrium via the proximal port of a pulmonary artery catheter.
Measured: 4 Months
Accuracy of Cardiac Output
The secondary objective of this study is to validate cardiac output (the amount of blood the heart pumps per minute) measurements made using CoVa Patch to those made using a pulmonary artery catheter and the thermodilution method.
Thermodilution requires a pulmonary artery catheter and are calculated by a monitoring system based on temperature changes in the heart when a cooler solution is injected into the right atrium via the proximal port of a pulmonary artery catheter.
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start19 Feb 2020
- Primary completion9 Apr 2020
- Study completion9 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac FailureStudies 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
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, Los Angeles
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255108
- Sponsor's protocol ID
- TS-IRB-0003.1
- Status last verified
- Jan 2022
- First submitted
- 30 Jan 2020
- Last updated
- 20 Jan 2022
- 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 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Sensor for Non-invasive Measurement of Stroke Volume and Cardiac Output
- ClinicalTrials.gov ID
- NCT04255108
- Acronym / sponsor ID
- TS-IRB-0003.1
- Conditions
- Cardiac Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Collaborators
- University of California, Los Angeles
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 9 Apr 2020 (actual)
- Study completion
- 9 Apr 2020 (actual)
- First posted
- 5 Feb 2020 (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.
toSense, Inc. has developed a novel, non-invasive, body-worn sensor -CoVa Patch-that offers an alternative to invasive continuous cardiac output monitoring. To validate this new sensor's measurements of stroke volume and cardiac output, toSense, Inc. will conduct a study that compares its measurement performance to that from a pulmonary artery catheter using the thermodilution method.
Detailed description
This in an introductory clinical study with cardiac ICU patients featuring CoVa Patch. This is a single site, non-blinded, non-randomized study. It will employ a retrospective analysis comparing the accuracy of SV and CO. The 'test sensor', CoVa Patch, which will measure SV and CO quasi-continuously and non-invasively, approximately every 5-30 minutes for a period of time lasting approximately 12-48 hours. These measurements will be compared to those from a 'reference device', which is the pulmonary arterial catheter. It uses an invasive technique called thermodilution that will be made approximately every 4 hours. Measurements between the test and reference devices will be compared in a retrospective analysis once the study has completed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men/Women who meet the inclusion/exclusion criteria | – | Device: Cova Patch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Men and woman over the age of 18 years old.
Key inclusion criteria (4 listed)
- Male or female ≥ 18 years of age at Visit X.
- Subject is a patient in the Cardiac ICU and meets the following criteria: pulmonary artery catheterization scheduled or completed.
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
- Subject is not pregnant at the time of consent
Key exclusion criteria (3 listed)
- Pregnant in the study.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Subject is unable or unwilling to wear electrode patches as required for a period between 6 to 48 hours.
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 |
|---|---|---|
| Cova PatchCoVa Patch will measure quasi-continuously, approximately every 5 minutes for a period between 6 to 48 hours | Device | Men/Women who meet the inclusion/exclusion criteria |
Primary outcome
Accuracy of Stroke Volume
Time frame: 4 Months
The primary objective of this study is to validate stroke volume (the amount of blood pumped by the left ventrical of the heart in one contraction) measurements made using CoVa Patch to those made using a pulmonary artery catheter and the thermodilution method. Thermodilution requires a pulmonary artery catheter and are calculated by a monitoring system based on temperature changes in the heart when a cooler solution is injected into the right atrium via the proximal port of a pulmonary artery catheter.
Accuracy of Cardiac Output
Time frame: 4 Months
The secondary objective of this study is to validate cardiac output (the amount of blood the heart pumps per minute) measurements made using CoVa Patch to those made using a pulmonary artery catheter and the thermodilution method. Thermodilution requires a pulmonary artery catheter and are calculated by a monitoring system based on temperature changes in the heart when a cooler solution is injected into the right atrium via the proximal port of a pulmonary artery catheter.
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 20 Jan 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Failure, run by Baxter Healthcare 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 4 inclusion and 3 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 20 Jan 2022. 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?
Accuracy of Stroke Volume (time frame: 4 Months). 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 20 Jan 2022.