- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06425887
Smartwatch Paroxysmal Arrhythmia Detection Compared With Holter
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients referred for out-patient Holter exam from age 18 - 80 years old
The following indications for Holter exam will be allowed for recruitment
- Palpitation
- Pre-syncope
- Dizziness
Exclusion Criteria:
- Patients with a prior ECG diagnosis to explain the symptom
- Primary symptom is syncope
- Patient who has no clear indication for Holter exam
- Pregnant ladies
- Patients who failed to make a successful recording despite teaching attempts.
- Patients who cannot read English or Chinese version of consent.
- Anticipation of non-compliance with recording protocol.
- Patients who do not have a compatible smart phone (Android 9.0 or newer, or iOS15 or newer)
- Patients under custody
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison
Time Frame: through study completion, an average of 1 month
|
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
|
through study completion, an average of 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detection rate
Time Frame: through study completion, an average of 1 month
|
describe the detection rate of smartwatch for various arrhythmia
|
through study completion, an average of 1 month
|
Preference
Time Frame: through study completion, an average of 1 month
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Smartwatch vs Holter study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Arrythmia
-
Shahid Beheshti University of Medical SciencesUnknownArrythmiaIran, Islamic Republic of
-
Medical College of WisconsinMedtronic; University of Wisconsin, MilwaukeeCompletedCardiovascular Diseases | Physical Activity | Arrythmia | PacemakerUnited States
-
Centro Hospitalar e Universitário de Coimbra, E...Not yet recruiting
-
Won Young KimRecruitingCardiac Arrest | Ventricular ArrythmiaKorea, Republic of
-
Ottawa Heart Institute Research CorporationCompleted
-
MicroPort CRMUnknownHeart Failure | Ventricular Arrythmia | ICD | LeadSpain, Italy, France, Portugal
-
MicroPort CRMActive, not recruitingHeart Failure | Ventricular Arrythmia | ICD | LeadSpain, Portugal
-
Anesthesia Research Group UACompleted
-
Abbott Medical DevicesCompleted
Clinical Trials on Smart watch
-
University Hospital, BordeauxRecruiting
-
Inonu UniversityCompletedChronic Obstructive Pulmonary Disease | Breath ShortnessTurkey
-
National University of SingaporeSengkang General HospitalRecruitingFrailty | Mild Cognitive ImpairmentSingapore
-
Rambam Health Care CampusUnknownStress | Sleep DeprivationIsrael
-
Fundacio d'Investigacio en Atencio Primaria Jordi...Institut Català de la SalutRecruitingStroke | Atrial Fibrillation | Dementia | Atrial Fibrillation New OnsetSpain
-
Seoul National University HospitalRecruitingObstructive Sleep Apnea of Adult | Adherence, Treatment | Positive Airway Pressure | Smart WatchKorea, Republic of
-
Kansas City Heart Rhythm Research FoundationTerminatedAtrial FibrillationUnited States
-
Samsung Medical CenterEnrolling by invitationOccupational Exposure | Medical Emergencies | Occupational Problems | Occupational BurnoutKorea, Republic of
-
University of Kansas Medical CenterGarmin InternationalUnknownAtrial FibrillationUnited States