NCT05686330

Brief Summary

This is a randomized controlled trial evaluating atrial fibrillation (AF) detection through smartwatch-based screening in high-risk patients using an Apple Watch with integrated PPG and ECG functions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
436

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 16, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 16, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 17, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2025

Completed
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

2.7 years

First QC Date

December 16, 2022

Last Update Submit

September 10, 2025

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationCardiac arrhythmiaSmartwatchWearable technologyDigital healthPhotoplethysmographyElectrocardiographyRemote monitoringScreeningRandomized controlled trialOutpatient careTelemedicine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • The time until atrial fibrillation is first detected (days)

    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 patients that undergo major cardiovascular events during the study period

    6 months

  • Number of emergency department visits

    6 months

  • The number of new arrhythmia diagnoses other than AF in each study arm

    6 months

Study Arms (2)

Interventional group (Apple watch)

EXPERIMENTAL

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 experiences any symptoms or 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

Control group

NO INTERVENTION

Patients in the control group received standard care, which could include conventional rhythm monitoring methods such as Holter monitoring, in-hospital telemetry, or the use of handheld mobile ECG devices, at the discretion of the treating cardiologist. At the end of the study period the investigator will either call the participant to check for these outcome measures.

Interventions

Apple WatchDEVICE

Smartwatch for detecting atrial fibrillation using photoplethysmography (PPG)

Also known as: Smartwatch
Interventional group (Apple watch)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cardiology Center of the Netherlands

Amsterdam, North Holland, Netherlands

Location

Spaarne Gasthuis

Haarlem, North Holland, 2035 RC, Netherlands

Location

Related Publications (1)

  • van Steijn NJ, Blommestijn IS, Blok S, Pepplinkhuizen S, Somsen GA, Knops RE, Breukel L, Tijssen JGP, Tulevski II, Croon PM, Winter MM. Enhanced Detection and Prompt Diagnosis of Atrial Fibrillation Using Apple Watch: A Randomized Controlled Trial. J Am Coll Cardiol. 2026 Jan 22:S0735-1097(25)10337-9. doi: 10.1016/j.jacc.2025.11.032. Online ahead of print.

    PMID: 41569211DERIVED

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

December 16, 2022

First Posted

January 17, 2023

Study Start

November 16, 2022

Primary Completion

July 17, 2025

Study Completion

July 17, 2025

Last Updated

September 16, 2025

Record last verified: 2025-09

Locations

NL(2)