An observational study in Arrythmia, sponsored by Chinese University of Hong Kong. Status unknown at 1 site in Hong Kong. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-10-28.
Sponsored by Chinese University of Hong Kong · Observational
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.
915 studies on the registry are indexed under Arrhythmias, Cardiac; 234 are open to participants now.
This study's planned enrollment of 185 is close to the median of 200 across 426 observational studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →Chinese University of Hong Kong is the lead sponsor of 1,446 studies on the registry; 467 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients being referred for out-patient Holter exam will be reviewed for eligibility. Individuals aged 18 to 80 with indications for Holter including palpitation, pre-syncope \& dizziness without meeting any exclusions will be invited to participate in this study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The following indications for Holter exam will be allowed for recruitment
Exclusion Criteria:
not interventional
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%
Time frame: through study completion, an average of 1 month
Detection rate
describe the detection rate of smartwatch for various arrhythmia
Time frame: through study completion, an average of 1 month
Preference
describe patients' preference on using which modality (smartwatch or Holter) to record their arrhythmia, by means of a questionnaire
Time frame: through study completion, an average of 1 month
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2024 (actual). Primary completion is estimated for Jul 2026, 24 months after the start.
Of 181 non-industry observational studies under Arrhythmias, Cardiac, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 109. This study's planned 24 months is below that.
Counting every sponsor, half of 243 studies reached it within 37 months; a quarter within 15 and three quarters within 91.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong →