Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT06425887

Smartwatch Paroxysmal Arrhythmia Detection Compared with Holter

Led by Chinese University of Hong Kong · Updated on 2024-10-28

185

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Smartwatch Paroxysmal Arrhythmia Detection Compared with Holter

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 to 80 years referred for outpatient Holter exam
  • Patients experiencing palpitations, pre-syncope, or dizziness as indications for Holter exam
Not Eligible

You will not qualify if you...

  • Patients with a prior ECG diagnosis explaining their symptoms
  • Patients whose primary symptom is syncope
  • Patients without a clear indication for Holter exam
  • Pregnant women
  • Patients unable to make a successful smartwatch recording despite teaching
  • Patients unable to understand English or Chinese consent forms
  • Patients expected to not comply with recording protocol
  • Patients without a compatible smartphone (Android 9.0 or newer, or iOS 15 or newer)
  • Patients currently under custody

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Prince of Wales Hospital

Hong Kong, Hong Kong

Actively Recruiting

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Research Team

T

Tsz Kin Mark Tam

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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