Smartwatch Paroxysmal Arrhythmia Detection Compared With Holter

Arrythmia Clinical Trial

Official title:

Smartwatch Paroxysmal Arrhythmia Detection Compared With Holter

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06425887
• Other study ID #: Smartwatch vs Holter study
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: July 1, 2026

Study information

• Verified date: May 2024
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 185
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2026
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 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 or newer)

9. Patients under custody

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Arrythmia

Intervention

Diagnostic Test:
• Smart watch
not interventional

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison	Compare the percentage of patients with significant arrhythmia diagnosed, between smartwatch rhythm recording and 24-hour Holter arm Significant arrhythmia is defined as the presence of any one of the following; Sustained supraventricular tachycardia (>=30 seconds); Atrial fibrillation (>=30 seconds); Ventricular tachycardia of more than 3 consecutive beats; Significant AV block (defined as 2nd degree Mobitz type II or 3rd degree heart block); HR less than 40 while awake.; Pause > 2 seconds while awake (for both smartwatch and Holter), or >3 seconds while asleep (for Holter only); Premature ventricular complex with an overall burden of more than 10%	through study completion, an average of 1 month
Secondary	Detection rate	describe the detection rate of smartwatch for various arrhythmia	through study completion, an average of 1 month
Secondary	Preference	describe patients' preference on using which modality (smartwatch or Holter) to record their arrhythmia, by means of a questionnaire	through study completion, an average of 1 month