Atrial FibrillationNCT04074434
Study Watch Atrial Fibrillation (AF) Detection Investigation
An observational study of Atrial Fibrillation, run by Verily Life Sciences LLC at 1 site in United States.
Trial summary
This is a prospective, non-randomized study to refine the Study Watch's algorithm for AF detection within both persistent and paroxysmal AF subjects. The study will also collect data from an FDA-cleared wearable ECG sensor. 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?
- Study Watch
- Type of treatment
- Medical device
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2018to 22 Jul 2019
- 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: Subjects with a known history of AF (including persistent or paroxysmal AF)
Who may be able to join
- At least 18 years old
- Able to read and speak English
- Able and willing to sign written Informed Consent
- Interest in participating in the study
- Subjects with a known history of AF (including persistent or paroxysmal AF)
- Without significant limitation in ability to participate in the study, in the opinion of the investigator.
Who cannot join
- Currently in a paced rhythm
- Known severe allergy to nickel or metal jewelry
- Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego Cardiac Center
San Diego, California, 92123
About this study
This is a prospective, non-randomized study to refine the Study Watch's algorithm for AF detection within both persistent and paroxysmal AF subjects. The study will also collect data from an FDA-cleared wearable ECG sensor.
- Conditions
- Atrial Fibrillation
- Being tested
- Study Watch
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study WatchDevice
Study Watch is a miniaturized physiological data monitoring and data collection device for continuous recording of physiological and environmental data
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Not described Receives: Device: Study Watch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate of the accuracy of algorithm based PPG irregular rhythm detection in a study population with a history of paroxysmal or persistent atrial fibrillation (AF)
Sensitivity estimate for PPG irregular rhythm detection vs. a multi-lead Holter ECG rhythm
Measured: At least 60 minutes
PPG- and ECG-based continuous AF-detection algorithms on Study Watch in a free-living (home) setting by comparing the Study Watch data with an FDA-cleared wearable ECG sensor data.
Number of AF events identified from FDA-cleared ECG Device
Measured: 14 days
Secondary outcomes (2)
Estimate of the accuracy of algorithm based PPG irregular rhythm detection in a study population with a history of paroxysmal or persistent atrial fibrillation (AF)
Predictive value estimate for PPG irregular rhythm detection vs. a multi-lead Holter ECG rhythm
Measured: At least 60 minutes
Spontaneously-reported participant usability feedback for Study Watch and its ECG feature in a free-living (home) setting with the target AF population.
Qualitative listing of participant-reported feedback
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start12 Nov 2018
- Primary completion17 Jul 2019
- Study completion22 Jul 2019
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.
- 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Verily Life Sciences LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074434
- Sponsor's protocol ID
- 100145
- Status last verified
- Aug 2019
- First submitted
- 22 Aug 2019
- Last updated
- 3 Sep 2019
- 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 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Watch Atrial Fibrillation (AF) Detection Investigation
- ClinicalTrials.gov ID
- NCT04074434
- Acronym / sponsor ID
- 100145
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Verily Life Sciences LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 17 Jul 2019 (actual)
- Study completion
- 22 Jul 2019 (actual)
- First posted
- 30 Aug 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.
This is a prospective, non-randomized study to refine the Study Watch's algorithm for AF detection within both persistent and paroxysmal AF subjects. The study will also collect data from an FDA-cleared wearable ECG sensor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Device: Study Watch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with a known history of AF (including persistent or paroxysmal AF)
Key inclusion criteria (6 listed)
- At least 18 years old
- Able to read and speak English
- Able and willing to sign written Informed Consent
- Interest in participating in the study
- Subjects with a known history of AF (including persistent or paroxysmal AF)
Key exclusion criteria (3 listed)
- Currently in a paced rhythm
- Known severe allergy to nickel or metal jewelry
- Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies
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 |
|---|---|---|
| Study WatchStudy Watch is a miniaturized physiological data monitoring and data collection device for continuous recording of physiological and environmental data | Device | All Participants |
Primary outcome
Estimate of the accuracy of algorithm based PPG irregular rhythm detection in a study population with a history of paroxysmal or persistent atrial fibrillation (AF)
Time frame: At least 60 minutes
Sensitivity estimate for PPG irregular rhythm detection vs. a multi-lead Holter ECG rhythm
PPG- and ECG-based continuous AF-detection algorithms on Study Watch in a free-living (home) setting by comparing the Study Watch data with an FDA-cleared wearable ECG sensor data.
Time frame: 14 days
Number of AF events identified from FDA-cleared ECG Device
2 secondary outcomes
Estimate of the accuracy of algorithm based PPG irregular rhythm detection in a study population with a history of paroxysmal or persistent atrial fibrillation (AF)
Time frame: At least 60 minutes
Spontaneously-reported participant usability feedback for Study Watch and its ECG feature in a free-living (home) setting with the target AF population.
Time frame: 14 days
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 3 Sep 2019.
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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 Atrial Fibrillation, run by Verily Life Sciences LLC 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 6 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 3 Sep 2019. 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?
Estimate of the accuracy of algorithm based PPG irregular rhythm detection in a study population with a history of paroxysmal or persistent atrial fibrillation (AF) (time frame: At least 60 minutes). 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 3 Sep 2019.