Atrial Fibrillation Algorithms Clinical Validation Study

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the performances of investigational Irregular Rhythm Notification Feature (version 2.0) and Atrial Fibrillation History Feature algorithms.

Detailed Description
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The purpose of the study is to evaluate the performances of investigational Irregular Rhythm Notification Feature (version 2.0) and Atrial Fibrillation History Feature algorithms.

Official Title
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Atrial Fibrillation Algorithms Clinical Validation Study

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: ELECTROCARDIOGRAM (ECG) PATCH WEAR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to read, understand, and provide written informed consent Willing and able to participate in the study procedures as described in the consent form Be 22 years of age and older Able to communicate effectively with and follow instructions from the study staff Able to wear the wrist device for duration of study participation For Cohort 1, have no known medical history of AF For Cohort 2, have no known medical history of AF and active diagnosis of at least one of the following arrhythmias within the past 2 years: Frequent PACs, defined as at least 1% of total beats of atrial ectopic beats by 24-48 hour Holter, ambulatory ECG monitor, or implantable loop recorder) Frequent PVCs, defined as at least 1% of total beats of ventricular ectopic beats by 24-48 hour Holter, ambulatory ECG monitor, or implantable loop recorder SVT, which will include atrial tachycardia, atrioventricular nodal re-entrant tachycardia, atrioventricular re-entrant tachycardia by 12-lead ECG or 24-48 hour Holter, ambulatory ECG monitor, or implantable loop recorder NSVT, defined as three or more consecutive ventricular beats at a rate of at least 100 beats per minute and lasting no more than 30 seconds, by 12-lead ECG or 24-48 hour Holter, ambulatory ECG monitor, or implantable loop recorder For Cohorts 3 and 4, have a known diagnosis of AF at the time of screening (confirmed by electronic medical record (EMR) or self-report) and have had a recent episode of AF, or confirmed AF on ECG, in the past 12 months For Cohort 4, have a known diagnosis of permanent AF at the time of screening (confirmed by EMR or self-report) and have had a recent episode of AF, or confirmed AF on ECG, in the past 12 months Meet additional binning based on demographics. Exclusion Criteria: Physical disability that precludes safe and adequate testing Mental impairment resulting in limited ability to cooperate Known uncontrolled medical conditions, such as (but not limited to) significant anemia, important electrolyte imbalance and untreated or uncontrolled thyroid disease Open wound(s) on the wrist and/or forearm Tattoos, large moles, or scars on the wrist at the wrist device location Skin conditions on either wrist that would preclude subject from wearing a wristband on either wrist Known allergy or sensitivity to medical adhesives, isopropyl alcohol, wristbands, or ECG patch Medical history or physical assessment finding that makes the subject inappropriate for participation according to investigator(s) Participation in a previous study that used a wrist-worn sensor device with a simultaneous ECG reference patch Implantable cardiac devices such as a Pacemaker or Implantable Cardioverter Defibrillator Clinically significant hand tremors, as judged by the investigator Acute illness including COVID and other respiratory illnesses Subjects with known history of AF on rhythm control medications with history of complete AF rhythm control (i.e history of zero AF burden) will be excluded from Cohorts 3 and 4

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: COHORT 1<br>This will include subjects with no known history of AF | Device: ELECTROCARDIOGRAM (ECG) PATCH WEAR<br>* ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION<br>* Other names: CARDEASOLO;|
| Other: COHORT 2<br>This will include subjects with no known history of aF, but with history of frequent premature atrial contractions (PACs), frequent premature ventricular contractions (PVCs), supraventricular tachycardia (SVT), or non-sustained ventricular tachycardia (NSVT) | Device: ELECTROCARDIOGRAM (ECG) PATCH WEAR<br>* ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION<br>* Other names: CARDEASOLO;|
| Other: COHORT 3<br>This will include subjects with known history of paroxysmal, persistent, or chronic AF | Device: ELECTROCARDIOGRAM (ECG) PATCH WEAR<br>* ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION<br>* Other names: CARDEASOLO;|
| Other: COHORT 4<br>Will include subjects with permanent AF | Device: ELECTROCARDIOGRAM (ECG) PATCH WEAR<br>* ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION<br>* Other names: CARDEASOLO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SENSITIVITY OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF] | Sensitivity of the irregular rhythm notification for the identification of persons with AF by 13-day ambulatory ECG, with AF defined as at least 30 seconds of AF by ambulatory ECG. Sensitivity is defined as the percentage of subjects exhibiting AF on the ambulatory ECG who also received an irregular rhythm notification concordant with at least one episode of AF. | 13 DAYS | 
| SPECIFICITY OF LACK OF IRREGULAR RHYTHM NOTIFICATIONS FEATURE [IRNF] | Specificity of the lack of irregular rhythm notification for the identification of persons without AF by 13-day ambulatory ECG, with AF defined as at least 30 seconds of AF by ambulatory ECG. Specificity is defined as the percentage of subjects not exhibiting AF on the ambulatory ECG who also did not receive any irregular rhythm notifications. | 13 DAYS | 
| WEEKLY ATRIAL FIBRILLATION BURDEN FEATURE ESTIMATE [AFBF] | Weekly AF burden estimate defined as the percentage of time a subject is in Atrial Fibrillation during wrist device wear over the prior 7 consecutive days. The weekly AF burden was estimated by both the reference device and the algorithm and reported using the Bland-Altman limits of Agreement. | 13 DAYS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POSITIVE PREDICTIVE VALUE OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF] | Notification-level positive predictive value (PPV) with AF by ambulatory ECG at the time of any tachogram comprising the notification. | 13 DAYS | 
| TACHOGRAM ALERT SENSITIVITY [IRNF] | Tachogram-level sensitivity performance for tachograms comprising alerts. | 13 DAYS | 
| TACHOGRAM ALERT SPECIFICITY [IRNF] | Tachogram-level specificity performance for tachograms comprising alerts. | 13 DAYS | 
| Tachogram Alert False Positive Rate [IRNF] | Tachogram-level False Positive rate performance for tachograms comprising alerts. | 13 DAYS | 
| Tachogram Alert Positive Predictive Value [IRNF] | Tachogram-level Positive Predictive value performance for tachograms comprising alerts. | 13 DAYS | 
| Tachogram Alert Negative Predictive Value [IRNF] | Tachogram-level Negative Predictive value performance for tachograms comprising alerts. | 13 DAYS | 
| TACHOGRAM SENSITIVITY [IRNF] | Tachogram-level sensitivity performance for all generated tachograms. | 13 DAYS | 
| TACHOGRAM SPECIFICITY [IRNF] | Tachogram-level specificity performance for all generated tachograms. | 13 DAYS | 
| TACHOGRAM FALSE POSITIVE RATE [IRNF] | Tachogram-level false positive rate performance for all generated tachograms. | 13 DAYS | 
| TACHOGRAM POSITIVE PREDICTIVE VALUE [IRNF] | Tachogram-level positive predictive value performance for all generated tachograms. | 13 DAYS | 
| TACHOGRAM NEGATIVE PREDICTIVE VALUE [IRNF] | Tachogram-level negative predictive value performance for all generated tachograms. | 13 DAYS | 
| TACHOGRAM SENSITIVITY [AFBF] | Sensitivity of tachograms for the identification of AF by ambulatory ECG. | 13 days | 
| TACHOGRAM SPECIFICITY [AFBF] | Specificity of tachograms for the identification of AF by ambulatory ECG. | 13 days | 
| TACHOGRAM POSITIVE PREDICTIVE VALUE [AFBF] | Positive Predictive Value of tachograms for the identification of AF by ambulatory ECG. | 13 days | 
| TACHOGRAM NEGATIVE PREDICTIVE VALUE [AFBF] | Negative Predictive Value of tachograms for the identification of AF by ambulatory ECG. | 13 days | 
| DAY-SPECIFIC AF BURDEN ESTIMATE [AFBF] | Day-specific AF burden estimate defined as the percentage of time a subject is in Atrial Fibrillation during a specific day of the week. | 13 DAYS | 
| FOUR-HOUR SEGMENT SPECIFIC AF BURDEN ESTIMATE [AFBF] | Four-hour segment-specific AF burden estimate defined as the percentage of time a subject is in Atrial Fibrillation during a specific four-hour segment of a day | 13 DAYS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CARDIOVASCULAR DISEASES, HEART DISEASES, ARRHYTHMIA, CARDIAC