Arrhythmias, CardiacNCT04556240
RECORD-VP: Real-time Evaluation of Cardiac Outpatient Recording Device With VitalPatch RTM
An observational study of Arrhythmias, Cardiac, run by VitalConnect Inc. at 1 site in United States.
Trial summary
The primary purpose of this study is to evaluate performance and safety of the VitalConnect Platform when used for mobile cardiac telemetry (MCT) or as an independent diagnostic testing facility (IDTF) system during activities of daily living by subjects 18 years or older who have been recommended MCT by their care… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmias, Cardiac
- What is being tested?
- VitalConnect Platform
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2020to 30 Nov 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of up to five-hundred (500) non-randomized subjects who have been recommended mobile cardiac telemetry by their care provider.
Who may be able to join
- Age 18 years or older;
- If recommended mobile cardiac telemetry (MCT) by the care provider
- If instructed, be willing to record information such as daily activities and symptoms
- Able to speak, read, and write English.
Who cannot join
- Have extensive skin changes/diseases that preclude wearing the required number of devices on normal skin at the proposed wear sites;
- Have a known allergy to medical adhesives;
- Have any potentially life-threatening condition that (for example ventricular tachycardia or ventricular fibrillation), in the opinion of the Investigator, would interfere with their participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The primary purpose of this study is to evaluate performance and safety of the VitalConnect Platform when used for mobile cardiac telemetry (MCT) or as an independent diagnostic testing facility (IDTF) system during activities of daily living by subjects 18 years or older who have been recommended MCT by their care provider.
- Conditions
- Arrhythmias, Cardiac
- Being tested
- VitalConnect Platform
- Keywords
- Arrhythmias, Real-time Monitoring, Mobile Cardiac Telemetry, VitalPatch, Independent Diagnostic Testing Facility
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitalConnect PlatformDevice
The VitalConnect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological and irregular heart rhythm data in home and healthcare settings. This includes heart rate, electrocardiogram (ECG), heart rate variability (R-R interval), breathing rate, arrhythmia detection, body temperature, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data is transmitted wirelessly to a central location where it is stored for analysis. The VitalConnect Platform can be configured by authorized persons to notify healthcare professionals when physiological data falls outside selected parameters
What is being measured
The primary outcome is the main question the study is designed to answer.
Successfully detect heart rhythm of the study subjects using VitalConnect platform as a mobile cardiac telemetry unit
Monitor the heart rhythm of the study subjects initially for up to 24 hours and if the monitoring finds the issue that the doctor is looking for, the monitoring will be stopped. In most of the cases, the monitoring can continue for up to 30 days for each study subject
Measured: Each patient will be monitored for up-to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start15 Sep 2020 (estimated)
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Why it stopped: Study withdrawn due to COVID endemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmias, 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VitalConnect Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dennis Sheehan, MD, Principal investigator, VitalConnect Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556240
- Sponsor's protocol ID
- TP-323
- Status last verified
- Jul 2023
- First submitted
- 2 Sep 2020
- Last updated
- 27 Jul 2023
- 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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECORD-VP: Real-time Evaluation of Cardiac Outpatient Recording Device With VitalPatch RTM
- ClinicalTrials.gov ID
- NCT04556240
- Acronym / sponsor ID
- TP-323
- Conditions
- Arrhythmias, Cardiac
- Keywords
- Arrhythmias, Real-time Monitoring, Mobile Cardiac Telemetry, VitalPatch, Independent Diagnostic Testing Facility
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study withdrawn due to COVID endemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VitalConnect Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2020 (estimated)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 21 Sep 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.
The primary purpose of this study is to evaluate performance and safety of the VitalConnect Platform when used for mobile cardiac telemetry (MCT) or as an independent diagnostic testing facility (IDTF) system during activities of daily living by subjects 18 years or older who have been recommended MCT by their care provider.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of up to five-hundred (500) non-randomized subjects who have been recommended mobile cardiac telemetry by their care provider.
Key inclusion criteria (4 listed)
- Age 18 years or older;
- If recommended mobile cardiac telemetry (MCT) by the care provider
- If instructed, be willing to record information such as daily activities and symptoms
- Able to speak, read, and write English.
Key exclusion criteria (3 listed)
- Have extensive skin changes/diseases that preclude wearing the required number of devices on normal skin at the proposed wear sites;
- Have a known allergy to medical adhesives;
- Have any potentially life-threatening condition that (for example ventricular tachycardia or ventricular fibrillation), in the opinion of the Investigator, would interfere with their participation in the study.
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 |
|---|---|---|
| VitalConnect PlatformThe VitalConnect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological and irregular heart rhythm data in home and healthcare settings. This includes heart rate, electrocardiogram (ECG), heart rate variability (R-R interval), breathing rate, arrhythmia detection, body temperature, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data is transmitted wirelessly to a central location where it is stored for analysis. The VitalConnect Platform can be configured by authorized persons to notify healthcare professionals when physiological data falls outside selected parameters | Device | – |
Primary outcome
Successfully detect heart rhythm of the study subjects using VitalConnect platform as a mobile cardiac telemetry unit
Time frame: Each patient will be monitored for up-to 30 days
Monitor the heart rhythm of the study subjects initially for up to 24 hours and if the monitoring finds the issue that the doctor is looking for, the monitoring will be stopped. In most of the cases, the monitoring can continue for up to 30 days for each study subject
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 27 Jul 2023.
- 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.
Dennis Sheehan, MD principal investigator
VitalConnect Inc.
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 Arrhythmias, Cardiac, run by VitalConnect Inc. 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: withdrawn, as of the sponsor's last update on 27 Jul 2023. 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?
Successfully detect heart rhythm of the study subjects using VitalConnect platform as a mobile cardiac telemetry unit (time frame: Each patient will be monitored for up-to 30 days). 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 27 Jul 2023.