Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425887
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-03
Brief Title:
Smartwatch Paroxysmal Arrhythmia Detection Compared With Holter
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Smartwatch Paroxysmal Arrhythmia Detection Compared With Holter
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None