Congestive Heart FailureNCT04362553
Advanced Wireless, Wearable Sensors for Continuous Hemodynamic Monitoring
An observational study of Congestive Heart Failure, run by Northwestern University at 1 site in United States.
Trial summary
Percent agreement of vital signs monitoring between the experimental sensor and standard of care monitoring Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- wearable vital signs sensor
- Type of treatment
- Medical device
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 5 Sep 2022
- 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 65 years
- All sexes
- Adult, Older adult
Study population: Cardiology patients
Who may be able to join
- Patient's aged 18-65
- Patient's scheduled to undergo a Trans-thoracic Echocardiogram (TTE) in an outpatient cardiology clinic or admitted to the Cardiac Care Unit with a swan ganz catheter in place for continuous invasive hemodynamic monitoring
Who cannot join
- Patient's with fragile skin or skin conditions that would prevent them from having a sensor placed
- Patients undergoing exercise or drug induced cardiac stress test
- Patients with a visible wound at site of sensor placement 3.4. Patients with structural or functional limitations to peripheral blood flow (known upper extremity peripheral arterial disease, use of vasopressors etc.).
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Percent agreement of vital signs monitoring between the experimental sensor and standard of care monitoring
- Conditions
- Congestive Heart Failure
- Being tested
- wearable vital signs sensor
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wearable vital signs sensorDevice
vital signs monitoring during standard of care procedures; TTE, swan-ganz catheterization
| Study group | Role | What they receive |
|---|---|---|
| Adults | Adults scheduled to receive a TTE (Trans-esophogeal echocardiogram) Receives: Device: wearable vital signs sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent agreement with pilot sensor and current standard of vital signs monitoring
Percent agreement with pilot sensor and current standard of vital signs monitoring
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start1 Jun 2020
- Primary completion23 Nov 2020
- Study completion5 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuai (Steve) Xu, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362553
- Sponsor's protocol ID
- STU00210413
- Status last verified
- Sep 2022
- First submitted
- 15 Apr 2020
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- 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 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Wireless, Wearable Sensors for Continuous Hemodynamic Monitoring
- ClinicalTrials.gov ID
- NCT04362553
- Acronym / sponsor ID
- STU00210413
- Conditions
- Congestive Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 5 Sep 2022 (actual)
- First posted
- 27 Apr 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.
Percent agreement of vital signs monitoring between the experimental sensor and standard of care monitoring
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults | – | Device: wearable vital signs sensorAdults scheduled to receive a TTE (Trans-esophogeal echocardiogram) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Cardiology patients
Key inclusion criteria (2 listed)
- Patient's aged 18-65
- Patient's scheduled to undergo a Trans-thoracic Echocardiogram (TTE) in an outpatient cardiology clinic or admitted to the Cardiac Care Unit with a swan ganz catheter in place for continuous invasive hemodynamic monitoring
Key exclusion criteria (3 listed)
- Patient's with fragile skin or skin conditions that would prevent them from having a sensor placed
- Patients undergoing exercise or drug induced cardiac stress test
- Patients with a visible wound at site of sensor placement 3.4. Patients with structural or functional limitations to peripheral blood flow (known upper extremity peripheral arterial disease, use of vasopressors etc.).
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 |
|---|---|---|
| wearable vital signs sensorvital signs monitoring during standard of care procedures; TTE, swan-ganz catheterization | Device | Adults |
Primary outcome
Percent agreement with pilot sensor and current standard of vital signs monitoring
Time frame: 2 years
Percent agreement with pilot sensor and current standard of vital signs monitoring
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 28 Sep 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 Congestive Heart Failure, run by Northwestern University 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 2 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 28 Sep 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?
Percent agreement with pilot sensor and current standard of vital signs monitoring (time frame: 2 years). 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 28 Sep 2022.