Arrythmia, CardiacNCT04202718
VitalConnect VitalPatch ECG Interpretation/Arrhythmia Detection
A study testing VitalPatch Device in people with Arrythmia, Cardiac, run by Mercy Research at 1 site in United States.
Trial summary
Subjects in this study will wear the VitalPatch with the added ECG Interpretation and arrhythmia detection features which will expedite the identification of patients whose condition may rapidly deteriorate as well as eliminate the majority of non-actionable alarms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arrythmia, Cardiac
- What is being tested?
- VitalPatch Device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2020to 30 Nov 2020
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old,
- No skin trauma to the site where the patch will be applied
- No known allergies to hydrocolloid or silicone based adhesives
- Admitted to Mercy Hospital Washington Cardiac Unit on the 5th floor and have been placed in one of the assigned rooms and require cardiac/telemetry monitoring as ordered by their physician
Who cannot join
- Pacemaker or Implanted Defibrillator (ICD)
- Pregnancy
- Adults unable to provide informed consent
- Individuals who cannot read and understand English
- Prisoners
- Not recommended for use in MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
Mercy Hospital Washington
Washington, Missouri, 63090
About this study
Subjects in this study will wear the VitalPatch with the added ECG Interpretation and arrhythmia detection features which will expedite the identification of patients whose condition may rapidly deteriorate as well as eliminate the majority of non-actionable alarms.
Read the detailed description
This project intends to validate, through comparative study, the output of new technologies (ECG Interpretation and arrhythmia detection) to the VistaCenter platform, aiming to replace current telemetry monitoring equipment. The new technology, through the previous Mercy pilot study, has demonstrated greater accuracy in the detection of ventricular tachycardia patterns and other dysrhythmias/arrhythmias, as well as, reducing the volume of false alarms resulting in the mitigation of alarm fatigue experienced by bedside staff and monitor technicians.
- Conditions
- Arrythmia, Cardiac
- Being tested
- VitalPatch Device
- Keywords
- ECG Interpretation
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitalPatch DeviceDiagnostic test
The VitalPatch® is an IRB (791130) and FDA approved wearable device that allows for the constant monitoring of biometric measurements and may have utility in the health management of individuals at high-risk for poor health outcomes and in the detection or prevention of adverse events within settings where more traditional telemetry monitoring devices are not currently in use.
| Study group | Role | What they receive |
|---|---|---|
| Single group | Other | Where a wearable biosensor is being considered for use in the health management of individuals at high-risk for poor health outcomes, and in the detection or prevention of adverse events within settings where traditional monitoring devices are not currently in use, the ECG interpretation will provide Arrhythmia detection which will help ensure that irregular rhythms will be reported quickly. Receives: Diagnostic Test: VitalPatch Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in false alarms received from current telemetry monitoring technology
- Compare generation of false alarms with VitalPatch and current telemetry monitoring
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start15 May 2020 (estimated)
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Why it stopped: Study never started due to COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrythmia, CardiacStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mercy Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashok Palagiri, Mercy Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202718
- Sponsor's protocol ID
- 20-007
- Status last verified
- Jun 2020
- First submitted
- 16 Dec 2019
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VitalConnect VitalPatch ECG Interpretation/Arrhythmia Detection
- ClinicalTrials.gov ID
- NCT04202718
- Acronym / sponsor ID
- 20-007
- Conditions
- Arrythmia, Cardiac
- Keywords
- ECG Interpretation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started due to COVID-19 pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mercy ResearchUniversity, hospital or other
- Study start
- 15 May 2020 (estimated)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 18 Dec 2019 (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.
Subjects in this study will wear the VitalPatch with the added ECG Interpretation and arrhythmia detection features which will expedite the identification of patients whose condition may rapidly deteriorate as well as eliminate the majority of non-actionable alarms.
Detailed description
This project intends to validate, through comparative study, the output of new technologies (ECG Interpretation and arrhythmia detection) to the VistaCenter platform, aiming to replace current telemetry monitoring equipment. The new technology, through the previous Mercy pilot study, has demonstrated greater accuracy in the detection of ventricular tachycardia patterns and other dysrhythmias/arrhythmias, as well as, reducing the volume of false alarms resulting in the mitigation of alarm fatigue experienced by bedside staff and monitor technicians.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | Other | Diagnostic Test: VitalPatch DeviceWhere a wearable biosensor is being considered for use in the health management of individuals at high-risk for poor health outcomes, and in the detection or prevention of adverse events within settings where traditional monitoring devices are not currently in use, the ECG interpretation will provide Arrhythmia detection which will help ensure that irregular rhythms will be reported quickly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old,
- No skin trauma to the site where the patch will be applied
- No known allergies to hydrocolloid or silicone based adhesives
- Admitted to Mercy Hospital Washington Cardiac Unit on the 5th floor and have been placed in one of the assigned rooms and require cardiac/telemetry monitoring as ordered by their physician
Key exclusion criteria (6 listed)
- Pacemaker or Implanted Defibrillator (ICD)
- Pregnancy
- Adults unable to provide informed consent
- Individuals who cannot read and understand English
- Prisoners
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 |
|---|---|---|
| VitalPatch DeviceThe VitalPatch® is an IRB (791130) and FDA approved wearable device that allows for the constant monitoring of biometric measurements and may have utility in the health management of individuals at high-risk for poor health outcomes and in the detection or prevention of adverse events within settings where more traditional telemetry monitoring devices are not currently in use. | Diagnostic test | Single group |
Primary outcome
Reduction in false alarms received from current telemetry monitoring technology
Time frame: 6 months
• Compare generation of false alarms with VitalPatch and current telemetry monitoring
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
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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?
A study testing VitalPatch Device in people with Arrythmia, Cardiac, run by Mercy Research 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 6 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: withdrawn, as of the sponsor's last update on 24 Jun 2020. 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 was withdrawn before enrolling participants, so there are no results.
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?
Reduction in false alarms received from current telemetry monitoring technology (time frame: 6 months). 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 24 Jun 2020.