Study Watch AF Detection At Home

Atrial Fibrillation Clinical Trial

Official title:

Study Watch AF Detection At Home

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04546763
• Other study ID #: 102238
• Status: Completed
• Start date: September 3, 2020
• Est. completion date: May 14, 2021

Study information

• Verified date: October 2021
• Source: Verily Life Sciences LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: May 14, 2021
• Est. primary completion date: May 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Study Watch
The Study Watch is a miniaturized wearable device made with biocompatible contact materials containing various sensors capable of measuring physiological and environmental metrics.
• Zio XT
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.

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas
United States	UPMC Pinnacle Harrisburg	Harrisburg	Pennsylvania
United States	Colorado Heart and Vascular	Lakewood	Colorado
United States	San Diego Cardiac Center	San Diego	California
United States	Ascension Providence Hospital	Southfield	Michigan

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	Accuracy of AF detection - Sensitivity	Accuracy of AF detection based on sensitivity observed in a 14-day followup period	14 days
Primary	Accuracy of AF detection - Specificity	Accuracy of AF detection based on specificity observed in a 14-day followup period	14 days
Secondary	A sensitivity analysis estimating the range of sensitivities	A sensitivity analysis estimating the range of sensitivities when imputing insufficient quality data	14 days
Secondary	A sensitivity analysis estimating the range of specificities	A sensitivity analysis estimating the range of specificities when imputing insufficient quality data	14 days
Secondary	Estimates of sensitivity by protocol-defined subgroups	Estimates of sensitivity by protocol-defined subgroups	14 days
Secondary	Estimates of specificity in subgroups	Estimates of specificity in subgroups defined by: race, age-groups, site, activity levels, and AF-burden	14 days
Secondary	Estimates of positive predictive value (PPV) on the AF-burden	Estimates of PPV based on the AF-burden observed in the study	14 days
Secondary	Estimates of negative predictive value (NPV) on the AF-burden	Estimates of NPV based on the AF-burden observed in the study	14 days
Secondary	Estimates of PPV on the AF burden to a screening population	Estimates of PPV based on the AF burden relevant to a screening population	14 days
Secondary	Estimates of NPV on the AF burden to a screening population	Estimates of NPV based on the AF burden relevant to a screening population	14 days