Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2023-11-30
2024-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Paroxysmal Atrial Fibrillation Patients
Verily Watch Cardio
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 monitor
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-1
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.
Interventions
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Verily Watch Cardio
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 monitor
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-1
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.
Eligibility Criteria
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Inclusion Criteria
* 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:
1. Scheduled or to be scheduled to undergo AF ablation
2. 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
3. CHA2DS2VASc score ≥3
4. 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
Exclusion Criteria
* 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
* 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.
22 Years
ALL
No
Sponsors
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Verily Life Sciences LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Hamid Ghanbari, MD
Role: PRINCIPAL_INVESTIGATOR
Verily Life Sciences
Locations
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Colorado Heart and Vascular
Lakewood, Colorado, United States
Ascension Providence Hospital
Southfield, Michigan, United States
Wake Forest Medical Center
Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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104343
Identifier Type: -
Identifier Source: org_study_id