Smartwatch Paroxysmal Arrhythmia Detection Compared with Holter

Last updated: October 24, 2024
Sponsor: Chinese University of Hong Kong
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Treatment

Smart watch

Clinical Study ID

NCT06425887
Smartwatch vs Holter study
  • Ages 18-80
  • All Genders

Study Summary

The lifetime risk for development of atrial fibrillation, the commonest sustained arrhythmia in adults, is estimated to be 24%-27% for individuals of 40 years or older. Previous work showed that annual new diagnosis of AF is 11000-26000 in Hong Kong. Other arrhythmia such as supraventricular arrhythmia or premature beats were also common and of clinical significance.

12-lead ECG is a first line investigation for patients with suspected paroxysmal arrhythmia, but it has a low diagnostic yield with its 10-30 seconds recordings. 24-hour Holter exam is the usual next step of diagnosis. The diagnostic yield of Holter varies according to indication but is generally low at 1%-12%. This is because paroxysmal arrhythmia may not happen every day. In addition, even if arrhythmia is picked up in Holter, patient may not register the symptom, making the symptom arrhythmia correlation problematic.

Despite limitations, the demand for Holter exam is still high. In Prince of Wales Hospital, a tertiary referral centre with a catchment of about 1 million populations, the waiting time for a routine Holter exam is 3 years.

Smartwatch has gained popularity over past years as an adjunct to smartphone. Latest generations of smartwatch were equipped with wearer-initiated ECG rhythm strip recording capabilities. Smartwatch has evolved to become a health tracker with arrhythmia detection capabilities. It was found to be a useful tool for atrial fibrillation screening in general population. Other arrhythmias, such as supraventricular tachycardia, premature beats, and abnormal ECG patterns associated with sudden cardiac death could also be detected with smartwatch ECG recordings. Apple Heart study was the largest study utilizing smartwatch for arrhythmia detection. The general population was screened for atrial fibrillation using irregular pulse algorithm. The study found a 84% concordance rate between irregular pulse notification and ECG patches.

Therefore, investigators propose to conduct a study to compare its diagnostic yield with Holter, in patients with suspected arrhythmia and see if smartwatch recording following a systematic protocol for four-weeks will have better arrhythmia diagnosis yield than a 24-hour Holter exam.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. All patients referred for out-patient Holter exam from age 18 - 80 years old

  2. The following indications for Holter exam will be allowed for recruitment

  • Palpitation

  • Pre-syncope

  • Dizziness

Exclusion

Exclusion Criteria:

  1. Patients with a prior ECG diagnosis to explain the symptom

  2. Primary symptom is syncope

  3. Patient who has no clear indication for Holter exam

  4. Pregnant ladies

  5. Patients who failed to make a successful recording despite teaching attempts.

  6. Patients who cannot read English or Chinese version of consent.

  7. Anticipation of non-compliance with recording protocol.

  8. Patients who do not have a compatible smart phone (Android 9.0 or newer, or iOS15 ornewer)

  9. Patients under custody

Study Design

Total Participants: 185
Treatment Group(s): 1
Primary Treatment: Smart watch
Phase:
Study Start date:
July 01, 2024
Estimated Completion Date:
July 01, 2026

Connect with a study center

  • Prince of Wales Hospital

    Hong Kong,
    Hong Kong

    Active - Recruiting

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