Heart FailureNCT02337790
Necklace-Shaped Sensor for Non-Invasive Remote Monitoring of Vitals
An observational study of Heart Failure and Hypertension, run by Baxter Healthcare Corporation at 1 site in United States.
Trial summary
This study is designed to validate the use of the CoVa Monitoring System in subjects with implanted devices. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure, Hypertension
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to May 2015
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be from the Imperial Cardiac Clinic
Who may be able to join
- Subject is between 21 (twenty-one) and 95 (ninety-five) years of age at screening.
- Subject has a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device.
- Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study.
- Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition.
Who cannot join
- Subject is participating in another clinical study that may affect the results of either study.
- Subject is unable or not willing to wear electrode patches as required.
- Subject has skin sensitivity to adhesive or hydrogel materials used in electrode patches.
- Subject is considered by the PI to be medically unsuitable for study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Necklace-Shaped Sensor for Non-Invasive Monitoring of Fluids, Heart Rate, Heart Rate Variability, and Respiration Rate in Patients With a Pacemaker, Implanted Cardioverter-Defibrillator, or Ventricular Assist Device
This study is designed to validate the use of the CoVa Monitoring System in subjects with implanted devices.
Read the detailed description
The study had the following objectives:
- Verify that the CoVa Monitoring System does not interfere with implanted devices.
- Verify that implanted devices do not interfere with the functions of the CoVa Monitoring System.
- Verify that the CoVa Monitoring System fits on a wide variety of body types.
- Conditions
- Heart Failure, Hypertension
- Keywords
- Hypertension, Heart Failure, Fluids
- Medical subject headings
- Heart Failure, Hypertension
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 |
|---|---|---|
| Cohort 1 | Subjects will have a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Interference between implanted devices and CoVa Monitoring System
Measured: One time for up to 15 minutes during a clinic visit for device interrogation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionMay 2015
- Study completionMay 2015
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
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew J Banet, PhD, Principal investigator, Baxter Healthcare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337790
- Sponsor's protocol ID
- PERM-IRB-001-ICC
- Status last verified
- Dec 2015
- First submitted
- 9 Jan 2015
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Necklace-Shaped Sensor for Non-Invasive Monitoring of Fluids, Heart Rate, Heart Rate Variability, and Respiration Rate in Patients With a Pacemaker, Implanted Cardioverter-Defibrillator, or Ventricular Assist Device
- ClinicalTrials.gov ID
- NCT02337790
- Acronym / sponsor ID
- PERM-IRB-001-ICC
- Conditions
- Heart Failure, Hypertension
- Keywords
- Hypertension, Heart Failure, Fluids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 14 Jan 2015 (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.
This study is designed to validate the use of the CoVa Monitoring System in subjects with implanted devices.
Detailed description
The study had the following objectives:
- Verify that the CoVa Monitoring System does not interfere with implanted devices.
- Verify that implanted devices do not interfere with the functions of the CoVa Monitoring System.
- Verify that the CoVa Monitoring System fits on a wide variety of body types.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Subjects will have a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be from the Imperial Cardiac Clinic
Key inclusion criteria (4 listed)
- Subject is between 21 (twenty-one) and 95 (ninety-five) years of age at screening.
- Subject has a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device.
- Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study.
- Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition.
Key exclusion criteria (4 listed)
- Subject is participating in another clinical study that may affect the results of either study.
- Subject is unable or not willing to wear electrode patches as required.
- Subject has skin sensitivity to adhesive or hydrogel materials used in electrode patches.
- Subject is considered by the PI to be medically unsuitable for study participation.
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
Number of Patients with Interference between implanted devices and CoVa Monitoring System
Time frame: One time for up to 15 minutes during a clinic visit for device interrogation
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 30 Dec 2015.
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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, PhD principal investigator
Baxter Healthcare 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 Heart Failure and Hypertension, 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 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: finished, as of the sponsor's last update on 30 Dec 2015. 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?
Number of Patients with Interference between implanted devices and CoVa Monitoring System (time frame: One time for up to 15 minutes during a clinic visit for device interrogation). 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 30 Dec 2015.