Atrial FibrillationNCT03441022
Continuous Data Collection and Analysis for Stroke Prevention Using a Wearable Sensor
A study testing Amiigo Watch Only and Amiigo Watch + BodyGuardian in people with Atrial Fibrillation, run by Mayo Clinic.
Trial summary
The purpose of this study is to determine whether a wristband that detects your pulse can detect your heart rate and rhythm similar to electrocardiograms (ECG). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Amiigo Watch Only and Amiigo Watch + BodyGuardian
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2021to Aug 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18 years of age or older with a primary diagnosis of atrial fibrillation
- Willing and able to provide informed consent and follow the study protocol
- Clinically indicated planned restoration of normal rhythm
Who cannot join
- Unable to provide informed consent
- Unable to follow the study protocol
- Women who are pregnant
- Subjects with implantable devices (only if participating in phase 2-BodyGuardian processes/testing)
About this study
The purpose of this study is to determine whether a wristband that detects your pulse can detect your heart rate and rhythm similar to electrocardiograms (ECG).
Read the detailed description
The purpose of this study is to determine whether a wristband that detects your pulse can detect your heart rate and rhythm similar to electrocardiograms (ECG). These wristbands detect your pulse based on a technique called "photoplethysmography," (PPG). PPG is a common method in which an individual's pulse is detected based on a light signature interpreted by the wristband. Most commercially available heart rate monitors use PPG to determine your heart rate, but the accuracy is variable.
- Conditions
- Atrial Fibrillation
- Being tested
- Amiigo Watch Only, Amiigo Watch + BodyGuardian
- Keywords
- Cardioversion, BodyGuardian, Amiigo Wristband
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amiigo Watch OnlyDevice
Also called Cardioversion
Subjects will be asked to wear a wrist band with capabilities to detect their heart rate or rhythm on the basis of PPG on either wrist around the time of their cardioversion procedure. Data will be acquired from the wrist band at the same time as the electrocardiogram (ECG) monitor to which subjects are hooked up for the purposes of the cardioversion.
Amiigo Watch + BodyGuardianDevice
Also called Cardioversion plus 30 days
Subjects will be sent home after the cardioversion with a 30 day heart monitor called the BodyGuardian. This device continuously monitors their heart rate and rhythm and they will wear this on the chest. Subjects will also wear the wrist monitor over the same 30 day period.
| Study group | Role | What they receive |
|---|---|---|
| Cardioversion | Experimental | Amiigo watch during atrial fibrillation cardioversion. Optional sub-study: additional 30 days wearing Amiigo watch as well as BodyGuardian device. Receives: Device: Amiigo Watch Only; Device: Amiigo Watch + BodyGuardian |
What is being measured
The primary outcome is the main question the study is designed to answer.
Watch Accuracy during Cardioversion
Determine whether the R-R interval estimate from artifact-free non-invasive photoplethysmography sample waveform segments is a reasonable basis for a atrial fibrillation (AF) detection algorithm as compared to a gold standard measurement from ECG in the acute cardioversion setting
Measured: Duration of cardioversion procedure
Watch Accuracy compared to BodyGuardian
Determine the accuracy of ambulatory photoplethysmography for detection of heart rhythm when compared with a wearable clinically available 30 day monitor (BodyGuardian) in terms of accuracy of AF detection.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start15 Jul 2021 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Why it stopped: Unable to obtain equipment from Sponsor to be able to proceed with the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Koronis Biomedical Technologies, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Suraj Kapa, Mayo Clinic
- Investigators
- Suraj Kapa, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441022
- Sponsor's protocol ID
- 17-006346
- Other IDs
- 1R43AG058516-01
- Status last verified
- Sep 2021
- First submitted
- 15 Feb 2018
- Last updated
- 14 Sep 2021
- 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 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Data Collection and Analysis for Stroke Prevention Using a Wearable Sensor
- ClinicalTrials.gov ID
- NCT03441022
- Acronym / sponsor ID
- 17-006346
- Conditions
- Atrial Fibrillation
- Keywords
- Cardioversion, BodyGuardian, Amiigo Wristband
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to obtain equipment from Sponsor to be able to proceed with the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Koronis Biomedical Technologies, National Institute on Aging (NIA)
- Study start
- 15 Jul 2021 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 22 Feb 2018 (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 purpose of this study is to determine whether a wristband that detects your pulse can detect your heart rate and rhythm similar to electrocardiograms (ECG).
Detailed description
The purpose of this study is to determine whether a wristband that detects your pulse can detect your heart rate and rhythm similar to electrocardiograms (ECG). These wristbands detect your pulse based on a technique called "photoplethysmography," (PPG). PPG is a common method in which an individual's pulse is detected based on a light signature interpreted by the wristband. Most commercially available heart rate monitors use PPG to determine your heart rate, but the accuracy is variable.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardioversion | Experimental | Device: Amiigo Watch Only, Device: Amiigo Watch + BodyGuardianAmiigo watch during atrial fibrillation cardioversion. Optional sub-study: additional 30 days wearing Amiigo watch as well as BodyGuardian device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female 18 years of age or older with a primary diagnosis of atrial fibrillation
- Willing and able to provide informed consent and follow the study protocol
- Clinically indicated planned restoration of normal rhythm
Key exclusion criteria (4 listed)
- Unable to provide informed consent
- Unable to follow the study protocol
- Women who are pregnant
- Subjects with implantable devices (only if participating in phase 2-BodyGuardian processes/testing)
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 |
|---|---|---|
| Amiigo Watch OnlyAlso: CardioversionSubjects will be asked to wear a wrist band with capabilities to detect their heart rate or rhythm on the basis of PPG on either wrist around the time of their cardioversion procedure. Data will be acquired from the wrist band at the same time as the electrocardiogram (ECG) monitor to which subjects are hooked up for the purposes of the cardioversion. | Device | Cardioversion |
| Amiigo Watch + BodyGuardianAlso: Cardioversion plus 30 daysSubjects will be sent home after the cardioversion with a 30 day heart monitor called the BodyGuardian. This device continuously monitors their heart rate and rhythm and they will wear this on the chest. Subjects will also wear the wrist monitor over the same 30 day period. | Device | Cardioversion |
Primary outcome
Watch Accuracy during Cardioversion
Time frame: Duration of cardioversion procedure
Determine whether the R-R interval estimate from artifact-free non-invasive photoplethysmography sample waveform segments is a reasonable basis for a atrial fibrillation (AF) detection algorithm as compared to a gold standard measurement from ECG in the acute cardioversion setting
Watch Accuracy compared to BodyGuardian
Time frame: 30 days
Determine the accuracy of ambulatory photoplethysmography for detection of heart rhythm when compared with a wearable clinically available 30 day monitor (BodyGuardian) in terms of accuracy of AF detection.
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 14 Sep 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Suraj Kapa, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Amiigo Watch Only and Amiigo Watch + BodyGuardian in people with Atrial Fibrillation, run by Mayo Clinic.
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 3 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: withdrawn, as of the sponsor's last update on 14 Sep 2021. 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 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?
Watch Accuracy during Cardioversion (time frame: Duration of cardioversion procedure). The study lists 2 primary outcomes in all. 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 14 Sep 2021.