Study Watch AF Detection At Home

NCT04546763 | Completed FDA Device

• 1 other identifier: 102238
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Accuracy of AF detection - Sensitivity

  Accuracy of AF detection based on sensitivity observed in a 14-day followup period

  14 days

• Accuracy of AF detection - Specificity

  Accuracy of AF detection based on specificity observed in a 14-day followup period

  14 days

Secondary Outcomes (8)

• A sensitivity analysis estimating the range of sensitivities

  14 days

• A sensitivity analysis estimating the range of specificities

  14 days

• Estimates of sensitivity by protocol-defined subgroups

  14 days

• Estimates of specificity in subgroups

  14 days

• Estimates of positive predictive value (PPV) on the AF-burden

  14 days

Study Arms (1)

Paroxysmal Atrial Fibrillation Patients

This will be a single arm study of patients with paroxysmal atrial fibrillation. Subjects will be wearing the Study Watch and Zio XT Patch concurrently for up to 14 days.

Device: Study Watch; Device: Zio XT

Interventions

Study Watch DEVICE

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

Paroxysmal Atrial Fibrillation Patients

Zio XT DEVICE

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.

Paroxysmal Atrial Fibrillation Patients

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

At risk of having an AF event, as determined by having a diagnosis of paroxysmal AF (PAF)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Verily Life Sciences LLC: lead

Study Sites (5)

San Diego Cardiac Center

San Diego, California, 92123, United States

Location

Colorado Heart and Vascular

Lakewood, Colorado, 80228, United States

Location

Ascension Providence Hospital

Southfield, Michigan, 48075, United States

Location

UPMC Pinnacle Harrisburg

Harrisburg, Pennsylvania, 17011, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• Poh MZ, Battisti AJ, Cheng LF, Lin J, Patwardhan A, Venkataraman GS, Athill CA, Patel NS, Patel CP, Machado CE, Ellis JT, Crosson LA, Tamura Y, Plowman RS, Turakhia MP, Ghanbari H. Validation of a Deep Learning Algorithm for Continuous, Real-Time Detection of Atrial Fibrillation Using a Wrist-Worn Device in an Ambulatory Environment. J Am Heart Assoc. 2023 Oct 3;12(19):e030543. doi: 10.1161/JAHA.123.030543. Epub 2023 Sep 26.

  PMID: 37750558 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hamid Ghanbari

  Verily Life Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 14, 2020
• Study Start: September 3, 2020
• Primary Completion: May 14, 2021
• Study Completion: May 14, 2021
• Last Updated: October 6, 2021

Record last verified: 2021-10

Locations

US (5)