Clinical trial NCT05686330: Detection and Quantification of Atrial Fibrillation in High-risk Patients Using a Smartwatch Wearable (Apple Watch)
Official title: Enhanced Detection and Quickened Diagnosis of Atrial Fibrillation Using the Apple Watch: A Randomised Controlled Trial (EQUAL Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Wearable Electronic Devices
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 306
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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 or 8) 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 multicenter, 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: This is a multicenter Randomized Controlled trial to evaluate if 6-month 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, the number of patients with major adverse cardiovascular events, and other cardiac arrhythmias than AF diagnosed by a cardiologist.

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 or 8 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 implantable loop recorder (ILR) detects new-onset AF in 20.4% of high-risk patients within 6 months after implantation (12). It was estimated that wearing the AW for 12 hours daily would detect 50% of the cases detected with 24-hour monitoring using an ILR. Therefore, the estimated AF detection rate in the intervention arm in this study is 10.2%. Previous studies investigating AF detection with handheld devices, ILRs or patch monitors resulted in an average of 1.5 to 2.0 % AF detection in a control group within 6 months, resulting in an estimated AF detection rate of 1.7% in the control arm of this study. To achieve a 90% power to detect an absolute in-between group difference of 8.5% in diagnosing new onset AF, with a significance level of 5% in favour of the intervention group, a sample size of 306 patients (153 in each group) was required. During the study it was noticed that standard care rhythm monitoring was often initiated by the cardiologists, leading to a higher rate of AF detection in the control patients than was expected based on previous studies that were performed in primary care patients. Thus, on October 1 2023, the sample size was extended to 436 patients (218 per group) to further investigate the underlying factors influencing AF detection rates and time to diagnosis in this secondary care patient population.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of atrial fibrillation
timeFrame: 6 months
Secondary outcomes:
measure: The time until atrial fibrillation is first detected (days)
timeFrame: 6 months
measure: The number of patients for whom medication for AF is initiated at the end of the study (anticoagulation and antiarrhythmic drugs)
timeFrame: 6 months
measure: The number of patients that undergo major cardiovascular events during the study period
timeFrame: 6 months
measure: The number of new arrhythmia diagnoses other than AF in each study arm
timeFrame: 6 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Cardiology Center of the Netherlands
state: Noord-Holland
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuis
state: Noord-Holland
Study officials:
References: