Accuracy of Rhythm Detection by a Wearable Smart Watch for Cardiac Arrhythmias (The WATCH-RHYTHM Study)

Accuracy of Rhythm Detection and Managing Data Deluge by a Wearable Smart Watch for Cardiac Arrhythmias (The WATCH-RHYTHM Study)

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04499807

Enrollment

Registered

2020-08-05

Start date

2021-01-06

Completion date

2021-03-16

Last updated

2023-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Wearable technology, Smart Watch, ILR, AFib detection

Brief summary

It is an attempt to see the reliability of the Wearable Smart Watch in identifying atrial fibrillation and other arrhythmias compared to the data detected from ILRs.

Detailed description

The sensitivity, specificity, positive and negative predictive values for successful identification of normal sinus rhythm, atrial fibrillation and other rhythm disorders from the smart watch will compared to that of an ILR.

Interventions

OTHERAFib detection with wearable smart watch

Patients will transmit two rhythm strips every day through both the devices and additional transmission whenever they have symptoms (palpitations, skipped beats, shortness of breath and chest pain). The transmitted rhythm strips are de-identified and analyzed after assigning a unique ID for research purposes.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Age over 18 years old * Patients who have an implantable loop recorder for heart rhythm monitoring purposes * Having IOS iphone device that can be integrated into Apple Watch * Willing to sign a consent form and participate in the study

Exclusion criteria

* Hemodynamically unstable patients * Over 90 years of age * Presence of wrist tattoos * Presence of AV fistula on the wrist on which the wearable is worn. (If the contralateral wrist is unaffected, those patients can be included) * Presence of Implantable Cardiac Pacemaker and/or ICD * Patients with Parkinsons disease or tremors

Design outcomes

Primary

Measure	Time frame	Description
AFib detection with heart rate data measured by Smart Watch	5 months	Heart rate data generated by Smart Watch is used to assess their rhythm as confirmed by the ILR done during the same time.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026