Study Watch Atrial Fibrillation (AF) Detection Investigation

Atrial Fibrillation Clinical Trial

Official title:

Study Watch Atrial Fibrillation (AF) Detection Investigation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04074434
• Other study ID #: 100145
• Status: Completed
• Start date: November 12, 2018
• Est. completion date: July 22, 2019

Study information

• Verified date: August 2019
• Source: Verily Life Sciences LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: July 22, 2019
• Est. primary completion date: July 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Study Watch
Study Watch is a miniaturized physiological data monitoring and data collection device for continuous recording of physiological and environmental data

Locations

Country	Name	City	State
United States	San Diego Cardiac Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Verily Life Sciences LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At least 60 minutes
Primary	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	14 days
Secondary	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	At least 60 minutes
Secondary	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	14 days