Heart FailureNCT02719301
Necklace-Shaped Sensor for Non-Invasive Monitoring of Stroke Volume and Cardiac Output
An observational study of Heart Failure, run by Baxter Healthcare Corporation.
Trial summary
Study will compare measurements made with Necklace device for stroke volume/cardiac output with values from a FDA-approved reference device. The gold standard that will be used is Cardiac MRI. Subjects will be measured with both the Necklace, reference device, and the Cardiac MRI. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Jan 2017
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and Women between 18 and 85.
Who may be able to join
- Must be able to undergo Cardiac MRI
Who cannot join
- Sensitivity to electrodes
About this study
Official title: Necklace-Shaped Sensor for Non-Invasive Monitoring of Stroke Volume, Cardiac Output, Fluids, Heart Rate, Heart Rate Variability, and Respiration Rate
Study will compare measurements made with Necklace device for stroke volume/cardiac output with values from a FDA-approved reference device. The gold standard that will be used is Cardiac MRI. Subjects will be measured with both the Necklace, reference device, and the Cardiac MRI. Values calculated by the Cardiac MRI analysis will be compared with the reference device and the Necklace.
Read the detailed description
Study will compare measurements made with Necklace device for stroke volume/cardiac output with values from a FDA-approved reference device. The gold standard that will be used is Cardiac MRI. Subjects will be measured with both the Necklace, reference device, and the Cardiac MRI. Values calculated by the Cardiac MRI analysis will be compared with the reference device and the Necklace.
The Cardiac MRI will be received ~1-4 days after the measurement is completed. The data will be compared with data collected from the Necklace and the reference device during the study.
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Men/Women between 18 & 85 | Accepting both healthy and non-healthy subjects. A portion of the subjects will have a fluid management issue or heart failure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Stroke Volume Measurement from Necklace with Cardiac MRI measurement of Stroke Volume
Measured: Retrospective up to 6 months after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startSep 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart 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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew J Banet, Principal investigator, Baxter Healthcare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719301
- Sponsor's protocol ID
- PERM-IRB-001-CM
- Status last verified
- Jun 2017
- First submitted
- 17 Mar 2016
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Necklace-Shaped Sensor for Non-Invasive Monitoring of Stroke Volume, Cardiac Output, Fluids, Heart Rate, Heart Rate Variability, and Respiration Rate
- ClinicalTrials.gov ID
- NCT02719301
- Acronym / sponsor ID
- PERM-IRB-001-CM
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 25 Mar 2016 (estimated)
- 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.
Study will compare measurements made with Necklace device for stroke volume/cardiac output with values from a FDA-approved reference device. The gold standard that will be used is Cardiac MRI. Subjects will be measured with both the Necklace, reference device, and the Cardiac MRI. Values calculated by the Cardiac MRI analysis will be compared with the reference device and the Necklace.
Detailed description
Study will compare measurements made with Necklace device for stroke volume/cardiac output with values from a FDA-approved reference device. The gold standard that will be used is Cardiac MRI. Subjects will be measured with both the Necklace, reference device, and the Cardiac MRI. Values calculated by the Cardiac MRI analysis will be compared with the reference device and the Necklace.
The Cardiac MRI will be received ~1-4 days after the measurement is completed. The data will be compared with data collected from the Necklace and the reference device during the study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men/Women between 18 & 85 | – | –Accepting both healthy and non-healthy subjects. A portion of the subjects will have a fluid management issue or heart failure. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and Women between 18 and 85.
Key inclusion criteria (1 listed)
- Must be able to undergo Cardiac MRI
Key exclusion criteria (1 listed)
- Sensitivity to electrodes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of Stroke Volume Measurement from Necklace with Cardiac MRI measurement of Stroke Volume
Time frame: Retrospective up to 6 months after study completion
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 2 Jul 2017.
- 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.
Matthew J Banet principal investigator
Baxter Healthcare Corporation
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Baxter Healthcare Corporation.
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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Comparison of Stroke Volume Measurement from Necklace with Cardiac MRI measurement of Stroke Volume (time frame: Retrospective up to 6 months after study completion). 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 2 Jul 2017.