Detection and Quantification of Atrial Fibrillation in High-risk Patients Using a Smartwatch Wearable (Apple Watch)

Study Overview
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Brief Summary
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This is a Randomized Controlled trial to evaluate if continuous heart rate and -rhythm monitoring with a photoplethysmography (PPG) smartwatch wearable (Apple Watch series 5) can detect atrial fibrillation at an early stage in cardiac patients with a known high risk of developing AF (ChadsVasc score ≥ 2 men; ≥3 women; age ≥ 65). In this monocenter, single arm, prospective randomized controlled trial the investigators will enroll 306 patients (153 per arm). An absolute in between-group difference of 8.5% in diagnosing patients with new AF in favor of the interventional group during a six month study period is hypothesized.

Detailed Description
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This is a monocenter Randomized Controlled trial to evaluate if continuous heart rate and -rhythm monitoring with a photoplethysmography (PPG) smartwatch wearable (Apple Watch series 5) can detect atrial fibrillation (AF) at an early stage in cardiac patients with a known high risk of developing AF (age ≥ 65), who are also at higher risk of developing stroke if AF would occur (ChadsVasc score ≥ 2 men; ≥3 women). The primary objective of this trial is to investigate whether continuous rhythm monitoring with a smartwatch wearable will result in a higher incidence of AF in patients at high risk for but without previously known AF, compared to standard care alone. The secondary outcomes are time to first AF episode, initiation of therapies for AF, predictors of AF, the number of visits to the emergency department, the number of patients with major adverse cardiovascular events, and other cardiac arrhythmias than AF diagnosed by a cardiologist. In this monocenter, single arm, prospective randomized controlled trial the investigators will enroll 306 patients. Patients will be randomized into either the intervention group (n=153), who will be loaned an Apple watch for use, or the control group (n=153), who will receive their standard care alone. Participants in the intervention group will receive the Apple Watch series 5 wearable and instructions to download a mobile app for the Apple iPhone. The smartwatch and the app on the smartphone are coupled. During the six-month study period, continuous monitoring for at least 12 hours a day of heart rate and -rhythm will be conducted using PPG. If an irregular heart rhythm is detected, the participant is requested through the smart application to record a single-lead ECG, using the smartwatch. Data obtained from the smartwatch will be transferred to the mobile app and will then be assessed with a proprietary certified AF algorithm. The ECG-data will be automatically uploaded in a secure environment of a data center, where it is accessible for the Telecure team who will analyze and interpret the recordings. As soon as AF is newly diagnosed, the patient and the treating cardiologist will be informed. An absolute in between-group difference of 8.5% in diagnosing patients with new AF in favor of the interventional group during a six month study period is hypothesized.

Official Title
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Detection and Quantification of Atrial Fibrillation in High-risk Patients Using a Smartwatch Wearable (Apple Watch) With a Photoplethysmographic Sensor and ECG-functionality

Conditions
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Atrial Fibrillation, Wearable Electronic Devices

Intervention / Treatment
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* Device: Apple Watch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 65 years Chadsvasc score ≥2 for men and ≥ for women at the time of eligibility screening Written informed consent as documented by signature from the participant Possession of iPhone (6S or later) Exclusion Criteria: Diagnosis of atrial fibrillation or atrial flutter Currently on anticoagulation therapy Cardiac implanted electronic device (pacemaker, ICD) Smartwatch cannot be worn due to comprehensible reasons (allergic reactions, wounds, amputations, other) Significant mental or cognitive impairment

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional group (Apple watch)<br>These participants will wear a smartwatch (Apple Watch) for 6 months during 12 hours a day. The smartwatch will alarm the participant if an irregular heart rhythm is detected. When a participant receives an irregular heartbeat notification, they can record an ECG with the smartwatch. The ECG will automatically be sent to the Telecure team for evaluation. | Device: Apple Watch<br>* Smartwatch for detecting atrial fibrillation using photoplethysmography (PPG)<br>* Other names: Smartwatch;|
| No Intervention: Control group<br>These participants will be following standard care alone. These participants are instructed to notify the investigators when atrial fibrillation is detected or when they have visited the emergency department during these six months. At the end of the study period the investigator will either call the participant, or their treating physician to check for these outcome measures. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of atrial fibrillation | Detected with an Apple watch or with any other device such as a holter or on an ECG or telemetry | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time until atrial fibrillation is first detected (days) | The number of days between the date of inclusion and the date AF is detected | 6 months | 
| The number of patients for whom medication for AF is initiated at the end of the study (anticoagulation and antiarrhythmic drugs) |  | 6 months | 
| The number of visits to the emergency department during the study period |  | 6 months | 
| The number of patients that undergo major cardiovascular events during the study period |  | 6 months | 
| The number of new arrhythmia diagnoses other than AF in each study arm | Detected by either the Apple watch, telemetry, holter or other devices used to detect arrhythmias | 6 months |