Study Watch Atrial Fibrillation (AF) Detection Investigation
1 other identifier
observational
160
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 22, 2019
CompletedFirst Submitted
Initial submission to the registry
August 22, 2019
CompletedFirst Posted
Study publicly available on registry
August 30, 2019
CompletedSeptember 3, 2019
August 1, 2019
8 months
August 22, 2019
August 29, 2019
Conditions
Outcome Measures
Primary 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)
Sensitivity estimate for PPG irregular rhythm detection vs. a multi-lead Holter ECG rhythm
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
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)
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.
14 days
Study Arms (1)
All Participants
Interventions
Study Watch is a miniaturized physiological data monitoring and data collection device for continuous recording of physiological and environmental data
Eligibility Criteria
Subjects with a known history of AF (including persistent or paroxysmal AF)
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Diego Cardiac Center
San Diego, California, 92123, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2019
First Posted
August 30, 2019
Study Start
November 12, 2018
Primary Completion
July 17, 2019
Study Completion
July 22, 2019
Last Updated
September 3, 2019
Record last verified: 2019-08