Atrial FibrillationNCT06041373
Verily Watch Cardio (AF and ECG) Study
An observational study of Atrial Fibrillation, run by Verily Life Sciences LLC at 3 sites in United States.
Trial summary
This study is designed to evaluate the performance of the Verily Watch Cardio for recording electrocardiogram (ECG) and photoplethysmography (PPG) signals and detecting suspected atrial fibrillation (AF) episodes, in a free-living environment, in participants at risk for having an AF event. 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?
- Verily Watch Cardio, iRhythm Zio monitor and Schiller CARDIOVIT FT-1
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2023to Nov 2024
- 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
- Adult, Older adult
Study population: At risk of having an AF event determined by a diagnosis of paroxysmal atrial fibrillation (PAF)
Who may be able to join
- At least 22 years old
- Able to read and speak English
- Participant understands the study requirements and is able and willing to sign written Informed Consent
- At risk of having an AF event, as determined by having a diagnosis of paroxysmal AF (PAF) and meeting one or more of the following:
- Scheduled or to be scheduled to undergo AF ablation
- AF burden of ≥25% in the 3 months prior to consent date as confirmed via an implantable loop recorder (ILR), holter monitor, or adhesive monitoring patch
Show all 9Show fewer
- CHA2DS2VASc score ≥3
- Left atrial diameter ≥4.4 cm as confirmed by transthoracic echo (TTE) within one year of consent
- Without significant limitation in ability to participate in the study, in the opinion of the Investigator
Who cannot join
- Have a pacemaker or implantable cardioverter defibrillator (ICD)
- 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). Should be at least one week off 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 polyester, nylon, spandex, adhesives or hydrogels; or with family history of adhesive skin allergies
- Are diagnosed with persistent AF
Show all 9Show fewer
- Have an implantable neuro-stimulator
- Currently wearing an ECG patch that prevents the use of the FDA-cleared wearable ECG patch, at the discretion of the Investigator.
- Have discolored wrists (e.g., tattoos, ink), at the discretion of the Investigator.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Colorado Heart and Vascular
Lakewood, Colorado, 80228
Ascension Providence Hospital
Southfield, Michigan, 48075
Wake Forest Medical Center
Winston-Salem, North Carolina, 27157
About this study
This study is designed to evaluate the performance of the Verily Watch Cardio for recording electrocardiogram (ECG) and photoplethysmography (PPG) signals and detecting suspected atrial fibrillation (AF) episodes, in a free-living environment, in participants at risk for having an AF event.
- Conditions
- Atrial Fibrillation
- Being tested
- Verily Watch Cardio, iRhythm Zio monitor, Schiller CARDIOVIT FT-1
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verily Watch CardioDevice
The Verily Watch Cardio is an investigational wrist-worn wearable device containing multiple sensors to measure physiological and environmental metrics, including electrodes that enable a single-lead electrocardiogram (ECG) measurement and a photoplethysmogram (PPG) sensor to monitor for irregular pulses.
iRhythm Zio monitorDevice
The iRhythm Zio monitor, the reference device, is an FDA-cleared single-patient use, continuously recording ECG monitor that can be worn for up to 14 days.
Schiller CARDIOVIT FT-1Device
The Schiller CARDIOVIT FT-1, the reference device, is an FDA-cleared portable 12-lead ECG machine capable of recording continuous standard 12-lead resting ECG for up to 4 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Paroxysmal Atrial Fibrillation Patients | Not described Receives: Device: Verily Watch Cardio; Device: iRhythm Zio monitor; Device: Schiller CARDIOVIT FT-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of suspected AF episode detection
Sensitivity and Specificity of suspected AF episode detection by the irregular pulse detection algorithm
Measured: Up to 14 days
Secondary outcomes (4)
A sensitivity analysis estimating the range of sensitivities and specificities
A sensitivity analysis estimating the range of sensitivities and specificities observed when imputing missing test device data
Measured: Up to 14 days
Sensitivity and Specificity in defined subgroups
Sensitivity and Specificity in subgroups defined by: race, age-groups, activity level, skin-tone and AF-burden
Measured: Up to 14 days
Mean difference in Interbeat interval (IBI) and the associated limits of agreement (LoA)
Mean difference in Interbeat interval (IBI) and the associated limits of agreement (LoA) based on recorded ECG data
Measured: Up to 14 days
Participant-level and heartbeat level sensitivity/specificity of P-wave detection
Participant-level and heartbeat level sensitivity/specificity of P-wave detection based on recorded ECG data
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study startNov 2023 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionNov 2024 (estimated)
Why it stopped: It was decided by Verily Leadership to not pursue the study any further.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Verily Life Sciences LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hamid Ghanbari, MD, Principal investigator, Verily Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041373
- Sponsor's protocol ID
- 104343
- Status last verified
- Dec 2023
- First submitted
- 11 Sep 2023
- Last updated
- 22 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verily Watch Cardio (AF and ECG) Study
- ClinicalTrials.gov ID
- NCT06041373
- Acronym / sponsor ID
- 104343
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: It was decided by Verily Leadership to not pursue the study any further.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Verily Life Sciences LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2023 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 18 Sep 2023 (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 study is designed to evaluate the performance of the Verily Watch Cardio for recording electrocardiogram (ECG) and photoplethysmography (PPG) signals and detecting suspected atrial fibrillation (AF) episodes, in a free-living environment, in participants at risk for having an AF event.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paroxysmal Atrial Fibrillation Patients | – | Device: Verily Watch Cardio, Device: iRhythm Zio monitor, Device: Schiller CARDIOVIT FT-1 |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- At risk of having an AF event determined by a diagnosis of paroxysmal atrial fibrillation (PAF)
Key inclusion criteria (9 listed)
- At least 22 years old
- Able to read and speak English
- Participant understands the study requirements and is able and willing to sign written Informed Consent
- At risk of having an AF event, as determined by having a diagnosis of paroxysmal AF (PAF) and meeting one or more of the following:
- Without significant limitation in ability to participate in the study, in the opinion of the Investigator
Key exclusion criteria (9 listed)
- Have a pacemaker or implantable cardioverter defibrillator (ICD)
- 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). Should be at least one week off 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 polyester, nylon, spandex, 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 |
|---|---|---|
| Verily Watch CardioThe Verily Watch Cardio is an investigational wrist-worn wearable device containing multiple sensors to measure physiological and environmental metrics, including electrodes that enable a single-lead electrocardiogram (ECG) measurement and a photoplethysmogram (PPG) sensor to monitor for irregular pulses. | Device | Paroxysmal Atrial Fibrillation Patients |
| iRhythm Zio monitorThe iRhythm Zio monitor, the reference device, is an FDA-cleared single-patient use, continuously recording ECG monitor that can be worn for up to 14 days. | Device | Paroxysmal Atrial Fibrillation Patients |
| Schiller CARDIOVIT FT-1The Schiller CARDIOVIT FT-1, the reference device, is an FDA-cleared portable 12-lead ECG machine capable of recording continuous standard 12-lead resting ECG for up to 4 minutes. | Device | Paroxysmal Atrial Fibrillation Patients |
Primary outcome
Sensitivity and Specificity of suspected AF episode detection
Time frame: Up to 14 days
Sensitivity and Specificity of suspected AF episode detection by the irregular pulse detection algorithm
4 secondary outcomes
A sensitivity analysis estimating the range of sensitivities and specificities
Time frame: Up to 14 days
Sensitivity and Specificity in defined subgroups
Time frame: Up to 14 days
Mean difference in Interbeat interval (IBI) and the associated limits of agreement (LoA)
Time frame: Up to 14 days
Participant-level and heartbeat level sensitivity/specificity of P-wave detection
Time frame: Up to 14 days
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 22 Dec 2023.
Related trials for Atrial Fibrillation
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
RecruitingObservational study
AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG
Heart Failure, Atrial Fibrillation (AF)
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Not yet recruiting
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
Atrial Fibrillation (AF)
Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation
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, MD principal investigator
Verily Life Sciences
3 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 3 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 9 inclusion and 9 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 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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?
Sensitivity and Specificity of suspected AF episode detection (time frame: Up to 14 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 22 Dec 2023.