Atrial FibrillationNCT04546763
Study Watch AF Detection At Home
An observational study of Atrial Fibrillation, run by Verily Life Sciences LLC at 5 sites in United States.
Trial summary
This is a multi-center, prospective, non-randomized study to evaluate the performance of the study watch PPG algorithm in detecting irregular rhythms suggestive of atrial fibrillation (AF) in subjects at risk of having an event of AF in the free living (home) environment. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Study Watch and Zio XT
- Type of treatment
- Medical device
- How many people
- 117 participants
- Where
- 5 sitesUnited States
- Study dates
- 3 Sep 2020to 14 May 2021
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: At risk of having an AF event, as determined by having a diagnosis of paroxysmal AF (PAF)
Who may be able to join
- At least 22 years old
- Able to read and speak English
- Able and willing to sign written Informed Consent
- Interest in participating in the study
- At risk of having an AF event, as determined by having a diagnosis of paroxysmal AF (PAF) and meeting one of the following: (a) scheduled or to be scheduled to undergo AF ablation, (b) with implantable loop recorder (ILR), implantable cardioverter defibrillator (ICD), permanent pacemaker (PPM), holter monitor, or adhesive monitoring patch with documented AF burden of ≥25% in the 3 months prior to consent date, (c) CHA2DS2VASc ≥3, (d) Left atrial diameter ≥4.4 cm
- Without significant limitation in ability to participate in the study, in the opinion of the investigator
Who cannot join
- Currently in a paced rhythm
- Currently on class Ic or class III antiarrhythmic medication that has been successful in eliminating AF (no documented AF of more than 30 seconds since the initiation of the medication)
- Had successful AF ablation (no documented AF of more than 30 seconds post procedure)
- Known severe allergy to nickel or metal jewelry
- Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies
- Are diagnosed with persistent AF
- Use of implantable neuro-stimulator
- Open injury or rash where the study device or comparator will be worn
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
UT Southwestern Medical Center
Dallas, Texas, 75390
UPMC Pinnacle Harrisburg
Harrisburg, Pennsylvania, 17011
Colorado Heart and Vascular
Lakewood, Colorado, 80228
San Diego Cardiac Center
San Diego, California, 92123
Ascension Providence Hospital
Southfield, Michigan, 48075
About this study
This is a multi-center, prospective, non-randomized study to evaluate the performance of the study watch PPG algorithm in detecting irregular rhythms suggestive of atrial fibrillation (AF) in subjects at risk of having an event of AF in the free living (home) environment.
- Conditions
- Atrial Fibrillation
- Being tested
- Study Watch, Zio XT
- 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
The Study Watch is a miniaturized wearable device made with biocompatible contact materials containing various sensors capable of measuring physiological and environmental metrics.
Zio XTDevice
The Zio XT Patch, the reference device, is a FDA-cleared single-patient use, continuously recording ECG monitor that can be worn up to 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Paroxysmal Atrial Fibrillation Patients | This will be a single arm study of patients with paroxysmal atrial fibrillation. Subjects will be wearing the Study Watch and Zio XT Patch concurrently for up to 14 days. Receives: Device: Study Watch; Device: Zio XT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of AF detection - Sensitivity
Accuracy of AF detection based on sensitivity observed in a 14-day followup period
Measured: 14 days
Accuracy of AF detection - Specificity
Accuracy of AF detection based on specificity observed in a 14-day followup period
Measured: 14 days
Secondary outcomes (8)
A sensitivity analysis estimating the range of sensitivities
A sensitivity analysis estimating the range of sensitivities when imputing insufficient quality data
Measured: 14 days
A sensitivity analysis estimating the range of specificities
A sensitivity analysis estimating the range of specificities when imputing insufficient quality data
Measured: 14 days
Estimates of sensitivity by protocol-defined subgroups
Estimates of sensitivity by protocol-defined subgroups
Measured: 14 days
Estimates of specificity in subgroups
Estimates of specificity in subgroups defined by: race, age-groups, site, activity levels, and AF-burden
Measured: 14 days
Estimates of positive predictive value (PPV) on the AF-burden
Estimates of PPV based on the AF-burden observed in the study
Measured: 14 days
Estimates of negative predictive value (NPV) on the AF-burden
Estimates of NPV based on the AF-burden observed in the study
Measured: 14 days
Estimates of PPV on the AF burden to a screening population
Estimates of PPV based on the AF burden relevant to a screening population
Measured: 14 days
Estimates of NPV on the AF burden to a screening population
Estimates of NPV based on the AF burden relevant to a screening population
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 posted14 Sep 2020
- Study start3 Sep 2020
- Primary completion14 May 2021
- Study completion14 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Verily Life Sciences LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hamid Ghanbari, Principal investigator, Verily Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546763
- Sponsor's protocol ID
- 102238
- Status last verified
- Oct 2021
- First submitted
- 4 Sep 2020
- Last updated
- 6 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Poh MZ, Battisti AJ, Cheng LF, Lin J, Patwardhan A, Venkataraman GS, Athill CA, Patel NS, Patel CP, Machado CE, Ellis JT, Crosson LA, Tamura Y, Plowman RS, Turakhia MP, Ghanbari H. Validation of a Deep Learning Algorithm for Continuous, Real-Time Detection of Atrial Fibrillation Using a Wrist-Worn Device in an Ambulatory Environment. J Am Heart Assoc. 2023 Oct 3;12(19):e030543. doi: 10.1161/JAHA.123.030543. Epub 2023 Sep 26.
PubMed 37750558
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Watch AF Detection At Home
- ClinicalTrials.gov ID
- NCT04546763
- Acronym / sponsor ID
- 102238
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Verily Life Sciences LLCIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 14 May 2021 (actual)
- Study completion
- 14 May 2021 (actual)
- First posted
- 14 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.
This is a multi-center, prospective, non-randomized study to evaluate the performance of the study watch PPG algorithm in detecting irregular rhythms suggestive of atrial fibrillation (AF) in subjects at risk of having an event of AF in the free living (home) environment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paroxysmal Atrial Fibrillation Patients | – | Device: Study Watch, Device: Zio XTThis will be a single arm study of patients with paroxysmal atrial fibrillation. Subjects will be wearing the Study Watch and Zio XT Patch concurrently for up to 14 days. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- At risk of having an AF event, as determined by having a diagnosis of paroxysmal AF (PAF)
Key inclusion criteria (6 listed)
- At least 22 years old
- Able to read and speak English
- Able and willing to sign written Informed Consent
- Interest in participating in the study
- At risk of having an AF event, as determined by having a diagnosis of paroxysmal AF (PAF) and meeting one of the following: (a) scheduled or to be scheduled to undergo AF ablation, (b) with implantable loop recorder (ILR), implantable cardioverter defibrillator (ICD), permanent pacemaker (PPM), holter monitor, or adhesive monitoring patch with documented AF burden of ≥25% in the 3 months prior to consent date, (c) CHA2DS2VASc ≥3, (d) Left atrial diameter ≥4.4 cm
Key exclusion criteria (8 listed)
- Currently in a paced rhythm
- Currently on class Ic or class III antiarrhythmic medication that has been successful in eliminating AF (no documented AF of more than 30 seconds since the initiation of the medication)
- Had successful AF ablation (no documented AF of more than 30 seconds post procedure)
- 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 WatchThe Study Watch is a miniaturized wearable device made with biocompatible contact materials containing various sensors capable of measuring physiological and environmental metrics. | Device | Paroxysmal Atrial Fibrillation Patients |
| Zio XTThe Zio XT Patch, the reference device, is a FDA-cleared single-patient use, continuously recording ECG monitor that can be worn up to 14 days. | Device | Paroxysmal Atrial Fibrillation Patients |
Primary outcome
Accuracy of AF detection - Sensitivity
Time frame: 14 days
Accuracy of AF detection based on sensitivity observed in a 14-day followup period
Accuracy of AF detection - Specificity
Time frame: 14 days
Accuracy of AF detection based on specificity observed in a 14-day followup period
8 secondary outcomes
A sensitivity analysis estimating the range of sensitivities
Time frame: 14 days
A sensitivity analysis estimating the range of specificities
Time frame: 14 days
Estimates of sensitivity by protocol-defined subgroups
Time frame: 14 days
Estimates of specificity in subgroups
Time frame: 14 days
Estimates of positive predictive value (PPV) on the AF-burden
Time frame: 14 days
Estimates of negative predictive value (NPV) on the AF-burden
Time frame: 14 days
Estimates of PPV on the AF burden to a screening population
Time frame: 14 days
Estimates of NPV on the AF burden to a screening 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 6 Oct 2021.
- Derived from this study: PubMed 37750558Poh MZ, Battisti AJ, Cheng LF, Lin J, Patwardhan A, Venkataraman GS, Athill CA, Patel NS, Patel CP, Machado CE, Ellis JT, Crosson LA, Tamura Y, Plowman RS, Turakhia MP, Ghanbari H. Validation of a Deep Learning Algorithm for Continuous, Real-Time Detection of Atrial Fibrillation Using a Wrist-Worn Device in an Ambulatory Environment. J Am Heart Assoc. 2023 Oct 3;12(19):e030543. doi: 10.1161/JAHA.123.030543. Epub 2023 Sep 26.
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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.
Hamid Ghanbari principal investigator
Verily Life Sciences
5 sites 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 5 sites 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 8 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 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Accuracy of AF detection - Sensitivity (time frame: 14 days). 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?
On the ClinicalTrials.gov record for NCT04546763, which also lists 1 linked publication.
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 6 Oct 2021.